National Medical Policy

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1 National Medical Policy Subject: Urinary Incontinence Devices and Treatments Policy Number: NMP215 Effective Date*: March 2005 Updated: October 2015 This National Medical Policy is subject to the terms in the IMPORTANT NOTICE at the end of this document For Medicaid Plans: Please refer to the appropriate State s Medicaid Manual(s), publication(s), citation(s), and documented guidance for coverage criteria and benefit guidelines prior to applying Health Net Medical Policies The Centers for Medicare & Medicaid Services (CMS) For Medicare Advantage members please refer to the following for coverage guidelines first: Use Source Reference/Website Link X National Coverage Determination (NCD) Non-Implantable Pelvic Floor Electrical Stimulator (230.8): Biofeedback Therapy for the treatment of Urinary Incontinence (30.1.1): Sacral Nerve Stimulation (230.18): National Coverage Manual Citation X Local Coverage Determination (LCD)* Radiofrequency Treatment for Urinary Incontinence: Posterior Tibial Nerve Stimulation (PTNS) for Urinary Control: Urological Supplies: Anorectal Manometry, Anal Electromyography, and Biofeedback Training FOR Perineal Muscles and Anorectal or Urethral Sphincters: Urinary Incontinence Devices and Treatments Oct 15 1

2 X Article (Local)* Posterior Tibial Nerve Stimulation Coverage: Urological Supplies; Sacral Nerve Stimulation for Urinary and Fecal Incontinence: X Other CMS. Decision Memo for Home Biofeedback For Urinary Incontinence: k+for+urinary+incontinence&ncdid=42&ncdver=1& IsPopup=y&bc=AAAAAAAACAAAAA%3D%3D& MLN Matters. Number: MM8257 Revised, Implemented October 7, Billing Social Work and Psychological Services in Comprehensive Outpatient Rehabilitation Facilities (CORFs): Education/Medicare-Learning-Network- MLN/MLNMattersArticles/downloads/MM8257.pdf None Use Health Net Policy Instructions Medicare NCDs and National Coverage Manuals apply to ALL Medicare members in ALL regions. Medicare LCDs and Articles apply to members in specific regions. To access your specific region, select the link provided under Reference/Website and follow the search instructions. Enter the topic and your specific state to find the coverage determinations for your region. *Note: Health Net must follow local coverage determinations (LCDs) of Medicare Administration Contractors (MACs) located outside their service area when those MACs have exclusive coverage of an item or service. (CMS Manual Chapter 4 Section 90.2) If more than one source is checked, you need to access all sources as, on occasion, an LCD or article contains additional coverage information than contained in the NCD or National Coverage Manual. If there is no NCD, National Coverage Manual or region specific LCD/Article, follow the Health Net Hierarchy of Medical Resources for guidance. Current Policy Statement (Please refer to NMP on Posterior Tibial Nerve Stimulation for Voiding Dysfunction) Health Net, Inc. considers any of the following incontinence devices and treatments medically necessary when the criteria have been met: Biofeedback Training We consider biofeedback training (up to a total of 10 sessions), used in conjunction with Kegel exercises, medically necessary to help patients only with stress or urge incontinence gain awareness and control of their pelvic muscles. Sacral Nerve Stimulation Urinary Incontinence Devices and Treatments Oct 15 2

3 Health Net, Inc considers sacral nerve stimulation (SNS) using the Medtronic Interstim SNS system medically necessary when all of the following criteria have been met: 1. Patient has a diagnosis of urge incontinence, urgency-frequency, or nonobstructive urinary retention; and 2. Symptoms of incontinence have been present for at least 12 months and have resulted in significant disability, such as the limited ability to work or participate in activities outside of the home; and 3. Incontinence is not related to a neurologic condition; and 4. Previous behavioral* and pharmacological therapy** has been unsuccessful for > 6 months; and 5. A percutaneous stimulation test to determine candidacy for a permanent implantation has provided at least a 50% reduction in incontinence symptoms as documented in voiding diaries. *Behavioral interventions to help people regain control of their bladder include pelvic floor exercises (Kegel exercises), biofeedback, bladder training which teaches people to resist the urge to void and gradually expand the intervals between voiding (timed voids), toileting assistance which uses routine or scheduled toileting, habit training schedules, and prompted voiding to empty the bladder regularly to prevent leaking, and fluid management. **Based on the reason for the incontinence, pharmacologic interventions can include two different anticholinergic drugs or a combination of an anticholinergic and a tricyclic antidepressant or alpha blockers and cholinergics, with antibiotics used for urinary tract infections. Periurethral Bulking Agents Health Net, Inc considers periurethral bulking agents using either cross-linked collagen or carbon-coated beads (e.g., Durasphere) medically necessary for the treatment of stress urinary incontinence when all of the following criteria have been met: 1. The patient has been diagnosed with stress incontinence due to intrinsic sphincter deficiency, or due to post traumatic or surgical injury; and 2. Stress urinary incontinence significantly limits activities of daily living; and 3. Patient has not shown any improvement in symptoms after at least 12 months of conservative measures such as behavioral or pharmacological treatments; and 4. No other causes of stress urinary incontinence have been identified (e.g., urinary tract infection). Note: If collagen implants are used, a skin test should be performed about a month prior to the implant to rule out hypersensitivity. No skin test is required for the carbon-coated beads. Note: Treatment is usually formed over the course of two to three visits to a physician. Up to five injection treatments may be covered, beyond that, the patient would be considered a treatment failure. Urinary Incontinence Devices and Treatments Oct 15 3

4 Note: The patient who has a reoccurrence of incontinence following a successful treatment series (i.e months previously) may benefit from additional treatments. Tension-Free Vaginal Tape (TVT) Procedure Health Net, Inc. considers the tension-free vaginal tape (TVT) procedure medically necessary in females with urodynamically proven stress urinary incontinence who have failed conservative therapy and may have also have failed prior surgical therapy (i.e., primary or recurrent stress urinary incontinence (SUI), and who are considered suitable candidates for surgical therapy, whether for SUI treatment alone or concurrently with other pelvic surgeries. Posterior Tibial Nerve Stimulation (PTNS) Health Net, Inc. considers posterior tibial nerve stimulation (PTNS) for the treatment of moderate to severe urinary dysfunction and overactive bladder symptoms medically necessary only in the short-term, up to 12 weeks. (i.e. 12 treatments of PTNS, 30 minutes, once-weekly, are usually needed for symptom relief)*. This would only be considered medically necessary when the following conditions are met: 1. The member has had urinary dysfunction for at least 12 months and the condition has resulted in significant disability (i.e., the frequency and or the severity of symptoms are limiting the member's ability to participate in daily activities); and 2. The member has tried various medications (e.g., alpha blockers and cholinergics, and antibiotics for urinary tract infections) as well as intermittent catheterization have failed or are not well-tolerated. *Note - If the member fails to improve after 12 PTNS treatments, continued treatment is considered not medically necessary. Not Medically Necessary Health Net, Inc. considers the following treatments and devices not medically necessary for the treatment of urinary incontinence: Biofeedback training for mechanical incontinence Sacral nerve stimulator for stress incontinence or urge incontinence due to a neurologic condition, such as detrusor hyperreflexia, multiple sclerosis, or spinal cord injury Transvaginal radiofrequency bladder neck suspension as a treatment of urinary stress incontinence Periurethral injections of the Teflon bulking agent Other investigational bulking agents, e.g., autologous fat and autologous ear chondrocytes FemSoft Insert for the control of adult female stress urinary incontinence Health Net, Inc considers the following treatment not medically necessary: Urinary Incontinence Devices and Treatments Oct 15 4

5 1. Vaginal weight training with specially designed weights (cones). (i.e., The use of vaginal weights (cones) has not been shown to improve pelvic floor muscle strength more than Kegel exercises alone) Investigational Health Net, Inc. considers radiofrequency thermal energy (i.e., Renessa System) as a treatment of urinary stress incontinence as investigational except for the following scenario: For the transurethral treatment of non-pregnant female stress urinary incontinence due to hypermobility, only in women who have failed 12 months of conservative treatment and who are not candidates for surgical treatment. Health Net, Inc. considers the following treatment investigational for the treatment of urinary incontinence: 1. Pelvic floor stimulation by electrical or magnetic methods 2. SURx Transvaginal System Urinary Incontinence Devices for Men Health Net, Inc. considers FDA approved artificial urinary sphincter devices for males (Eg. AMS 800) medically necessary for the treatment of type III stress urinary incontinence (complex or severe stress urinary incontinence), or intrinsic sphincteric dysfunction*. *Note - Patients with intrinsic sphincteric dysfunction include men with a history of radical retropubic or perineal prostatectomy or transurethral resection of the prostate (TURP), previous pelvic trauma, a history of pelvic radiation, spinal cord injuries, myelomeningoceles, or other causes of neurogenic bladder. Contraindications for placement of an artificial urinary sphincter include any of the following: Urinary tract infection. All candidates for an artificial urinary sphincter must have a sterile urine culture result preoperatively. Recurrent urethral strictures or diverticula. Detrusor hyperreflexia or instability. These conditions generate high intravesical pressures that are transmitted to the upper tracts and cause renal damage. Small capacity bladder or poorly compliant detrusor. Some patients with this contraindication, however, are candidates for an artificial urinary sphincter with concomitant or preoperative augmentation cystoplasty. Relative contraindications include any of the following: Grade 2 or higher vesicoureteral reflux should be corrected before artificial urinary sphincter placement. Recurrent disease that requires retrograde endoscopic instrumentation, such as stone disease or bladder or ureteral tumors. Bladder neck contractures (an infrequent complication of prostate surgery) should be treated first, and cystoscopy or retrograde urethrography should be Urinary Incontinence Devices and Treatments Oct 15 5

6 performed at least 3 months afterward to ensure continued patency of the bladder neck before proceeding with artificial urinary sphincter placement. Systemic leukocytosis should be treated before surgery. The patient should have normal renal function before AMS 800 artificial urinary sphincter placement. Codes Related To This Policy NOTE: The codes listed in this policy are for reference purposes only. Listing of a code in this policy does not imply that the service described by this code is a covered or noncovered health service. Coverage is determined by the benefit documents and medical necessity criteria. This list of codes may not be all inclusive. On October 1, 2015, the ICD-9 code sets used to report medical diagnoses and inpatient procedures will be replaced by ICD-10 code sets. Health Net National Medical Policies will now include the preliminary ICD-10 codes in preparation for this transition. Please note that these may not be the final versions of the codes and that will not be accepted for billing or payment purposes until the October 1, 2015 implementation date. ICD-9 Codes Intrinsic (urethral) sphincter deficiency Stress incontinence, female Retention of urine, unspecified Incomplete bladder emptying Other specified retention of urine Urge incontinence Stress incontinence, male Mixed incontinence (male) (female) Urinary frequency ICD-10 Codes N39- N39.3 Other disorders of urinary system N39.4- N39.46 Other specified urinary incontinence R33- R33.9 Retention of urine R35.Ø Frequency of micturition R39.1- R39.19 Other difficulties with micturation N39.41 Urge incontinence CPT Codes Endoscopic injection of implant material into the submucosal tissues of the urethra and/or bladder Transurethral, radiofrequency micro-remodeling of the female bladder neck and proximal urethra for stress urinary incontinence Unlisted procedure, urinary system Percutaneous implantation of neurostimulator electrodes; peripheral nerve (excludes sacral nerve) Urinary Incontinence Devices and Treatments Oct 15 6

7 64561 Percutaneous implantation of neurostimulator electrode array; sacral nerve (transforaminal placement), including image guidance (Code revised in 2013) Incision for implantation of neurostimulator electrodes; sacral nerve (transforaminal placement) (Revised in 2012) Revision or removal of peripheral neurostimulator electrode array (Revised in 2012) Biofeedback training, perineal muscles, anorectal or urethral sphincter, including EMG and /or manometry Electronic analysis of implanted neurostimulator pulse generator system (eg, rate, pulse, amplitude, pulse duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and patient compliance measurements); simple or complex brain, spinal cord, or peripheral (ie, cranial nerve, peripheral nerve, sacral nerve, neuromuscular) neurostimulator pulse generator/transmitter, without reprogramming. (Revised in 2012) Electronic analysis of implanted neurostimulator pulse generator system (eg, rate, pulse, amplitude, pulse duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and patient compliance measurements); simple spinal cord, or peripheral neurostimulator pulse (Revised in 2012) generator/transmitter, with intraoperative or subsequent programming Application of a modality to one or more areas; electric stimulation, unattended Application of a modality to one or more areas; electric stimulation, (manual) attended, each 15 minutes Unlisted modality (specify type and time if constant attendance) HCPCS Codes A4290 A4335 E0740 E0745 E0746 G0283 L8603 L8606 L8680 L8684 L8685 L8686 L8687 L8688 Sacral nerve stimulation test lead, each Incontinence supply, miscellaneous (Femsoft) (Medicare only) Incontinence treatment system, pelvic floor stimulator, monitor, sensor and/or trainer (Medicare only) Neuromuscular stimulator, electronic shock unit EMG biofeedback device (for home use) Electrical Stimulation (unattended), to one or more areas, for indication(s) other than wound care, as part of a therapy plan of care (Medicare only) Injectable bulking agent, collagen implant, urinary tract, per 2.5 ml syringe, including shipping supplies and necessary supplies Injectable bulking agent, synthetic implant, urinary tract, 1 ml syringe, includes shipping and necessary supplies. Implantable neurostimulator electrode, each Radiofrequency transmitter (external) for use with implantable sacral root neurostimulator receiver for bowel and bladder management, replacement Implantable neurostimulator pulse generator, single array, rechargeable, includes extension Implantable neurostimulator pulse generator, single array, nonrechargeable, includes extension Implantable neurostimulator pulse generator, dual array, rechargeable, includes extension Implantable neurostimulator pulse generator, dual array, nonrechargeable, includes extension Urinary Incontinence Devices and Treatments Oct 15 7

8 Q3031 For collagen skin test Scientific Rationale October 2015 Dumoulin et al. (2014) completed a study to determine the effects of pelvic floor muscle training for women with urinary incontinence in comparison to no treatment, placebo or sham treatments, or other inactive control treatments. The authors searched the Cochrane Incontinence Group Specialised Register. Randomised or quasi-randomised trials in women with stress, urgency or mixed urinary incontinence (based on symptoms, signs, or urodynamics). One arm of the trial included pelvic floor muscle training (PFMT). Another arm was a no treatment, placebo, sham, or other inactive control treatment arm. Trials were independently assessed by two review authors for eligibility and methodological quality. Data were extracted then cross-checked. Disagreements were resolved by discussion. Data were processed as described in the Cochrane Handbook for Systematic Reviews of Interventions. Trials were subgrouped by diagnosis of urinary incontinence. Formal meta-analysis was undertaken when appropriate. 21 trials involving 1281 women (665 PFMT, 616 controls) met the inclusion criteria; 18 trials (1051 women) contributed data to the forest plots. The trials were generally small to moderate sized, and many were at moderate risk of bias, based on the trial reports. There was considerable variation in the interventions used, study populations, and outcome measures. There were no studies of women with mixed or urgency urinary incontinence alone. Women with SUI who were in the PFMT groups were 8 times more likely than the controls to report that they were cured (46/82 (56.1%) versus 5/83 (6.0%), RR 8.38, 95% CI 3.68 to 19.07) and 17 times more likely to report cure or improvement (32/58 (55%) versus 2/63 (3.2%), RR 17.33, 95% CI 4.31 to 69.64). In trials in women with any type of urinary incontinence, PFMT groups were also more likely to report cure, or more cure and improvement than the women in the control groups, although the effect size was reduced. Women with either SUI or any type of urinary incontinence were also more satisfied with the active treatment, while women in the control groups were more likely to seek further treatment. Women treated with PFMT leaked urine less often, lost smaller amounts on the short office-based pad test, and emptied their bladders less often during the day. Their sexual outcomes were also better. Two trials (one small and one moderate size) reported some evidence of the benefit persisting for up to a year after treatment. Of the few adverse effects reported, none were serious. The findings of the review were largely supported by the summary of findings tables, but most of the evidence was down-graded to moderate on methodological grounds. The exception was 'Participant perceived cure' in women with SUI, which was rated as high quality. The review provides support for the widespread recommendation that PFMT be included in first-line conservative management programs for women with stress and any type of urinary incontinence, however, long-term effectiveness of PFMT needs to be further researched. Lipp et al. (2014) completed a study to determine whether mechanical devices are useful in the management of adult female urinary incontinence. For this second update the authors searched the Cochrane Incontinence Group Specialised Register. All randomised or quasi-randomised controlled trials of mechanical devices in the management of adult female urinary incontinence determined by symptom, sign or urodynamic diagnosis. The reviewers assessed the identified studies for eligibility and risk of bias and independently extracted data from the included studies. One new trial was identified and included in this update bringing the total to eight trials involving 787 women. Three small trials compared a mechanical device with no treatment and although they suggested that use of a mechanical device might be better than no treatment, the evidence for this was inconclusive. Four trials Urinary Incontinence Devices and Treatments Oct 15 8

9 compared one mechanical device with another. Quantitative synthesis of data from these trials was not possible because different mechanical devices were compared in each trial using different outcome measures. Data from the individual trials showed no clear difference between devices, but with wide confidence intervals. One trial compared three groups: a mechanical device alone, behavioural therapy (pelvic floor muscle training) alone and behavioural therapy combined with a mechanical device. While at three months there were more withdrawals from the device-only group, at 12 months differences between the groups were not sustained on any measure. The place of mechanical devices in the management of urinary incontinence remains in question. Currently there is little evidence from controlled trials on which to judge whether their use is better than no treatment and large well-conducted trials are required for clarification. There was also insufficient evidence in favour of one device over another and little evidence to compare mechanical devices with other forms of treatment. Lim et al. (2014) completed a study with the goal to review whether patients with urinary incontinence (UI) treated with magnetic stimulation (MS) have a higher continence rate compared to sham. Inclusion criteria were randomized, blinded and sham-controlled. Eight studies involving 494 patients were included (285 patients received active MS and 209 patients received sham MS). Sample size ranged from 20 to 151 participants. Three studies were on stress UI, two studies on urgency UI, two studies on mixed UI and one study on overactive bladder. The primary outcome (i.e., cure) was not reported since only one study reported this outcome. Meta-analysis of the secondary outcome (improvement) showed patients who received active treatment were 2.3 times more likely to experience improved continence compared to sham treatment (95% confidence interval: ; P<0.001), but was subject to bias due to varying inclusion criteria, poor reporting and variable time points. There were conflicting results in the treatment effect on quality of life (QOL). Twenty out of 494 patients (5%) experienced mild side effects. The longest follow up period was six months. There is no firm evidence to support the benefits of using MS in the management of UI, although short-term outcomes suggests that MS improves UI symptoms in women. The applicability of MS as a treatment option for UI remains uncertain until larger, high-quality trials with longer follow-up periods using comparable and relevant outcomes are conducted. Myers et al. (2014) completed a study to review the diagnosis and management of mixed urinary incontinence in women, with a focus on current available evidence. The MEDLINE search resulted in 785 articles. After selection and obtainment of additional citations, a total of 73 articles were reviewed. There is high-quality (level 1) evidence for treating urinary incontinence with weight loss, for treating stress urinary incontinence by performing anti-incontinence procedures of both traditional and mid-urethral slings and retropubic urethropexies, and for managing urge urinary incontinence with anticholinergic medications. However, direct high-quality evidence for treatment of women with mixed urinary incontinence is lacking, as are clear diagnostic criteria and management guidelines. High-quality, level 1 evidence for urinary incontinence therapy can guide clinicians in the treatment of the components of mixed urinary incontinence. Because high-quality evidence is lacking regarding the treatment of mixed urinary incontinence, treatment generally begins with conservative management emphasizing the most bothersome component. Randomized trials in women with mixed urinary incontinence populations are needed. Urinary Incontinence Devices and Treatments Oct 15 9

10 Qaseem et al. (2014) The American College of Physicians (ACP) developed this guideline to present the evidence and provide clinical recommendations on the nonsurgical management of urinary incontinence (UI) in women: RECOMMENDATION 1: ACP recommends first-line treatment with pelvic floor muscle training in women with stress UI. (Grade: strong recommendation, highquality evidence). RECOMMENDATION 2: ACP recommends bladder training in women with urgency UI. (Grade: strong recommendation, moderate-quality evidence). RECOMMENDATION 3: ACP recommends pelvic floor muscle training with bladder training in women with mixed UI. (Grade: strong recommendation, moderatequality evidence). RECOMMENDATION 4: ACP recommends against treatment with systemic pharmacologic therapy for stress UI. (Grade: strong recommendation, lowquality evidence). RECOMMENDATION 5: ACP recommends pharmacologic treatment in women with urgency UI if bladder training was unsuccessful. Clinicians should base the choice of pharmacologic agents on tolerability, adverse effect profile, ease of use, and cost of medication. (Grade: strong recommendation, high-quality evidence). RECOMMENDATION 6: ACP recommends weight loss and exercise for obese women with UI. (Grade: strong recommendation, moderate-quality evidence). There are currently no ongoing Clinical Trials on the SURx Transvaginal System or on the Renessa System as treatments for urinary incontinence. Scientific Rationale October 2013 Monga et al. (2013) completed this systematic literature review of clinical trial evidence for a range of electrical stimulation therapies in the treatment of lower urinary tract symptoms (LUTS). Seventy-three studies were included, representing implanted sacral nerve stimulation (SNS), percutaneous posterior tibial nerve stimulation (PTNS), and transcutaneous electrical stimulation (TENS) therapy modalities. Median mean reductions in incontinence episodes and voiding frequency were similar for implanted SNS and PTNS. However, long-term follow-up data to validate the sustained benefit of PTNS are lacking. Despite a substantial body of research devoted to SNS validation, it is not possible to definitively define the appropriate role of this therapy owing largely to study design flaws that inhibited rigorous intention to treat analyses for the majority of these studies. Management options for stress urinary incontinence (SUI) include conservative and surgical treatments. Midurethral sling placement has replaced other procedures (eg, retropubic colposuspension, bladder neck slings) as the procedure of choice for many women. The tension-free vaginal tape (TVT), introduced by Ulmsten in 1996, was the first synthetic retropubic midurethral sling. Since that time, variations of retropubic midurethral slings as well as midurethral transobturator slings have been introduced. TVT is a minimally invasive sling procedure for management of female SUI. The TVT procedure is based on the theory that SUI in women is mainly due to laxity of the vaginal connective tissue, which results when the pelvic floor muscles fail to stretch and insufficiently close off the urethra from behind. The surgical mesh tape implanted around the midurethra is designed to provide support when needed and is Urinary Incontinence Devices and Treatments Oct 15 10

11 in a tension-free state most of the time. Ultrasound data suggest that continence is achieved by compression of the urethra between the sling and the pubic symphysis. To ensure that the sling is tension-free and does not compress the urethra while the patient is at rest, many surgeons insert an instrument (i.e., Kelly clamp, etc.) between the sling and the urethra while adjusting the sling tension. Extracorporeal magnetic stimulation (EMS) is usually done by a urologist or gynecologist, during a regular office visit. The patients typically sit fully clothed in the treatment chair while the electromagnetic field is generated from a magnetic stimulator that is located beneath the pelvic floor and controlled by an external power unit. Armchair devices include the NeoControl Pelvic Floor Therapy System, now defunct, which is currently marketed outside the U.S. Scientific Rationale October 2012 The Ranessa System The Renessa System (Novasys Medical Inc.) is a non-surgical inoffice or outpatient procedure to treat stress urinary incontinence (SUI) due to bladder outlet hypermobility. It consists of a radiofrequency (RF) generator and probe. The probe is inserted through the urethra into the bladder, and is anchored in the bladder outlet by inflation of a balloon at its tip. Four needles arranged around the probe shaft are deployed into the tissue to deliver pulses of RF energy for 60 to 90 seconds. The RF energy raises the temperature near the needle tips to 65 C to 75 C, which breaks down a small area of urethral tissue. As it heals, the urethral tissue becomes firmer and less likely to open involuntarily, thereby reducing or eliminating SUI episodes. The U.S. FDA granted 510(k) approval to Novasys Medical Inc. for the Novasys Transurethral RF System (Renessa System) on July 22, The device is indicated for the transurethral treatment of female stress urinary incontinence due to hypermobility in women who have failed conservative treatment and who are not candidates for surgical therapy. Studies Dillon et al. (2009) Stress urinary incontinence (SUI) is a socially disabling disorder that affects a large population of women around the world. Surgical treatments for SUI typically seek to recapitulate the support of the endopelvic fascia and reduce urethral hypermobility or improve urethral compressive forces. Radio-frequency energy is a potent tool for such treatment, as it is in other medical specialties. The development of transurethral approach techniques affords a major advantage because this nonsurgical procedure can be performed in an office setting with the use of an oral sedative and local anesthesia. The data collected to date suggest that radiofrequency treatment of SUI has promising efficacy and entails a minimal risk of diverse events. Further peer-reviewed randomized studies are needed to assess the ultimate role of this procedure in future urology practice. Elser et al. (2009) presented an ongoing, multicenter, prospective uncontrolled trial, to assess the efficacy of Renessa in 136 women with stress urinary incontinence (SUI) caused by bladder outlet hypermobility. The patients had SUI for 12 months and did not respond to conservative therapy; none of the patients were candidates for surgery. Twelve month analysis of outcomes from intent-to-treat (ITT) analysis were reported. The patients were part of an ongoing, 3-year, single-arm study on the efficacy and safety of this therapy. All were treated as outpatients and received periurethral local anesthesia. The primary efficacy outcome was the percentage of patients who experienced a 50% reduction from baseline in urinary incontinence Urinary Incontinence Devices and Treatments Oct 15 11

12 episodes. Secondary measures of efficacy included subjective measures assessed by the IQOL questionnaire, the UDI-6, and the PGI-I. An in-office stress pad test was also conducted. The primary safety endpoints included device related and serious complications. By 12 months, 61 patients (45%) had withdrawn, were lost to followup, so that the ITT analysis was based on the outcomes of 75 patients. However, the ITT analysis found no significant differences between the patients who withdrew, and those who were evaluable at 12 months. At 12 months (n=136), the median number of leaks per day and leaks per week caused by activity had decreased from 2.1 (range 0.1 to 35.0) to 1.1 (range 0.0 to 20.0), and from a median of 15.0 (range 1.0 to 245.0) to 7.5 (0.0 to 140.0), respectively (both (P=0.0026). Sixty-eight patients (50%) had 50% fewer leaks compared with baseline (P<0.0001). The evaluable data on stress pad weight measurements (n=75) showed that 69% of patients had 50% reduction in leakage compared with baseline (median reduction 15.2 g; P<0.0001). Forty-five percent of patients were dry including 29% with no leaks and 16% with < 1 g of leakage. Interim results at 12 months of this 36-month study suggested that the therapy is relatively safe and efficacious in the short term with patients having significant improvements in both subjective and objective measures of SUI. While 53% of patients were very satisfied with their treatment results, just under half of the patients did not express such high levels of satisfaction. The authors noted that some patients might have had unrealistic expectations of the efficacy of this treatment. Limitations of the study include the lack of controls, inadequate follow-up time, and high attrition rate. While the authors had no financial interests in this therapy, the research was supported by Novasys Medical Inc.This study is limited by the large losses to follow-up and the evidence is insufficient to alter the conclusions reached above. Elser et al. (2011) completed the study noted above in 2009, to assess treatment efficacy and quality of life in women with SUI 3 years after treatment with Renessa. This prospective study included 139 women with SUI due to bladder outlet hypermobility. Assessments included incontinence quality of life (I-QOL) and urogenital distress inventory (UDI-6) instruments. Results. In total, 139 women were enrolled and 136 women were treated (mean age, 47 years). At 36 months, intentto-treat analysis ( = ) revealed significant improvements in quality of life. Mean I-QOL score improved 17 points from baseline ( = ), while mean UDI-6 score improved (decreased) 19 points ( = ). Transurethral collagen denaturation seems to be a low-risk, office-based procedure that results in durable quality-of-life improvements in a significant proportion of women for as long as 3 years. This three year time frame was the longest time frame for any study on Renessa. A limitation of this study includes the high dropout rate with regard to patients completing all of the in-office assessments, and lack of controls. Of the 136 women included in the intention to treat (ITT) analysis at 36-months, only 76 (55.9%) actually responded to the quality of life questionnaires (20 proceeded to surgery, 37 lost to follow-up, 3 discontinued participation due to study site closure).results are also reported on an ITT basis, including all enrolled patients, following application of a missing-value imputation technique appropriate for longterm studies where the improvement rate changes over time. Sensitivity analyses were also performed to explore differences in outcomes based on best- and worstcase assumptions regarding the outcomes of patients for whom no data was available. In addition, the lack of randomization, and single-arm studies lacking an adequate comparison/control group, means that the findings from these studies must be interpreted with caution. Urinary Incontinence Devices and Treatments Oct 15 12

13 There is currently a nonrandomized Clinical Trial on 'Renessa Objective and Subjective Efficacy Study (ROSE)' that is recruiting participants with the ClinicalTrials.gov Identifier of NCT The sponsor is Novasys Medical, Inc. The purpose of this study is to demonstrate the treatment efficacy of the Renessa System in women most likely to be treated in an office setting for the condition of stress urinary incontinence, secondary to urethral hypermobility. The estimated completion date is March Professional Societies On October 15, 2008, the California Technology Assessment Forum (CTAF) completed a review on Radiofrequency Micro-remodeling for the Treatment of Female Stress Urinary Incontinence. CTAF notes the following: The use of RF micro-remodeling for the treatment of female SUI and found that while RF micro-remodeling (Renessa) for SUI does not show as high success rates as the gold standard approaches (Burch and trans-vaginal tape), it does demonstrate a good safety profile and moderate improvement in objective urinary leakage and quality of life, particularly for women with moderate-to-severe SUI. CTAF s Recommendation: It is recommended that radiofrequency microremodeling with the Renessa system meets CTAF criteria 1-5 for safety, effectiveness and improvement in health outcomes for the treatment of moderate to severe female stress urinary incontinence in non-pregnant women who are either not able or not willing to undergo surgery for their SUI treatment. Although, the Ranessa System is not indicated for the initial treatment of urinary stress incontinence, CTAF does note that, "The Renessa System is indicated for the transurethral treatment of non-pregnant female stress urinary incontinence due to hypermobility, in women who have failed 12 months of conservative treatment and who are not candidates for surgical therapy". Percutaneous Tibial Nerve Stimulation (PTNS) for the Treatment of Overactive Bladder The U.S. FDA approved PTNS On October 10, They state: The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS). The Urgent PC Neuromodulation System is intended to treat patients with Overactive Bladder (OAB) and associated symptoms of urinary urgency, urinary frequency, and urge incontinence. Position Statements California Technology Assessment Forum (CTAF, 2012) notes: It is recommended that treatment of overactive bladder with PTNS meets CTAF TA criteria 1 through 5 for short-term benefit. It is recommended that treatment of overactive bladder with PTNS does not meet CTAF TA Criteria 4 and 5 for long-term benefit. CTAF based their summary on the following studies: Urinary Incontinence Devices and Treatments Oct 15 13

14 The Overactive Bladder Innovative Therapy Trial (ORBIT) was a randomized multicenter trial that compared PTNS to extended release tolterodine, a drug commonly used for the treatment of overactive bladder. A total of 100 adults with urinary frequency were randomized to receive 12 weeks of treatment with weekly PTNS or daily extended release tolterodine (4mg dose). Participants completed a voiding diary at baseline and at follow-up. They also completed an overactive bladder questionnaire both at baseline and at follow-up. Main outcomes were 24 hour voiding frequency, number of urinary urge incontinence episodes and quality of life outcomes. Global response assessments were completed by participants and study investigators after 12 weeks. Global response was measured as the percentage of participants reporting cure or improvement in symptoms. This study showed that PTNS was safe and efficacious at 12 weeks. Compared with pharmacotherapy, it resulted in improvement in patient assessment of bladder symptoms and in objective measures of bladder dysfunction. Efficacy was similar to that seen with pharmacotherapy (tolterodine). In the second phase of the ORBIT trial, study participants who had been randomized to PTNS were offered an additional nine months of treatment. They were assessed for OAB outcomes at six and 12 months. Study outcomes included voiding diaries, overactive bladder questionnaires, global response assessments and safety assessments. Forty five participants were originally included in the PTNS arm of ORBIT. Thirty five participants were responders and of those responders, 33 chose to continue PTNS treatment for the longer follow-up study. Participants needed to remain off OAB drugs for the study duration. With investigator supervision and using sound clinical judgment, participants were allowed to select the frequency of PTNS treatment that best controlled their symptoms. These treatments were all 30 minutes in duration. OAB symptoms were evaluated at six and 12 months and were compared to baseline and to the end of the initial 12 week treatment period. A total of 32 participants completed six months of follow up and 25 completed 12 months of follow-up. During the nine month follow-up period, the participants received a mean of 12.1 ± 4.9 treatments over 263 days. At six and 12 months, all voiding diary outcomes showed improvement compared with baseline. At 12 months, frequency was decreased by 2.8 voids daily (p<0.001) and urge incontinence was decreased by 1.6 episodes daily (p<0.001). All 33 subjects who completed the PTNS therapy rated symptoms on the GRA at the end of the initial 12 weeks of therapy as improved from baseline. At six months, 94% of patients rated OAB symptoms as improved from baseline and at 12 months, 96% rated symptoms as improved from baseline. Thus among individuals who respond to a 12 week course of once weekly PTNS, continued treatment for nine months results in continued symptom improvement at 12 month follow up. The authors do not currently know how they would respond to treatment beyond one year, nor what the impact would be for those who did not respond to the initial treatment. In addition, these conclusions about long term efficacy are based on 33 patients enrolled in a single trial. National Institute for Health and Clinical Excellence (NICE) NICE issued guidance on PTNS on October, 2010 stating Current evidence on PTNS for overactive bladder syndrome (OAB) shows that it is efficacious in reducing symptoms in the short and medium term. There are no major safety concerns. American Urology Association (AUA) In partnership with the Society of Urodynamics and Female Urology, the AUA published.diagnosis and Treatment of Overactive Bladder (non-neurogenic) in Urinary Incontinence Devices and Treatments Oct 15 14

15 Adults: AUA/SUFU Guideline in May The guideline offers the following statements about PTNS: Clinicians may offer percutaneous tibial nerve stimulation (PTNS) as third-line treatment in a carefully selected patient population. PTNS can benefit a carefully selected group of patients characterized by moderately severe baseline incontinence and frequency and willingness to comply with the PTNS protocol. Patients must also have the resources to make frequent office visits in order to obtain treatment because treatment effects dissipate once treatment ceases. As a group, the PTNS studies constitute Grade C evidence because of the predominant observational designs, varying patient inclusion criteria and short follow-up durations for most studies. Centers for Medicare and Medicaid Services (CMS) There is no National Coverage Determinations (NCD) for PTNS. Medicare carriers cover PTNS through a formal LCD for AZ and OR. Medicare has coverage articles for PTNS for California. Agency for Healthcare Research and Quality (AHRQ) In April 2012, AHRQ published the report: Nonsurgical Treatments for Urinary Incontinence in Adult Women: Diagnosis and Comparative Effectiveness.9 The report can be found at this link: Through a systematic review of diagnostic, randomized and nonrandomized studies found in major databases, FDA reviews, trial registries and research grant databases, the report goals were to assess methods to diagnose urinary incontinence (UI), monitor treatment effectiveness, and assess clinical efficacy and comparative effectiveness of pharmacological and nonsurgical treatments for UI. Key report conclusions relevant to this assessment include Benefits from pelvic floor muscle training, bladder training, and electrical stimulation are large, and adverse effects are uncommon. Benefits from drugs are small. Percutaneous tibial nerve stimulation improved UI. Individual RCTs indicated no difference in adverse effects and treatment discontinuation with active or sham stimulation. Comparative effectiveness of once versus three times per week posterior tibial nerve simulation resulted in the same outcomes in 35 subjects with urgency UI who failed oxybutynin treatment. (Zanetta et al. 2007) Blue Cross Blue Shield Association (BCBSA) The BCBSA Technology Evaluation Center (TEC) published its assessment of PTNS in March, The final outcome of the assessment was that PTNS did not meet TEC criteria. Canadian Agency for Drugs and Technologies in Health (CADTH) No reports were found on this topic at the CADTH website. American College of Obstetricians and Gynecologists (ACOG) The ACOG guideline, Urinary Incontinence for Women, did not mention PTNS as a management option for urinary incontinence. Urinary Incontinence Devices and Treatments Oct 15 15

16 Nager et al. (2009) began a clinical trial to evaluate long term efficacy of PTNS. The goal was to randomize those who had responded to PTNS after 12 weeks of treatment to once a month maintenance treatment or no maintenance treatment. According to the clinical trials website, this trial was reportedly suspended in March, 2010 due to low enrollment. In summary, per CTAF, randomized controlled trials have demonstrated efficacy of PTNS compared with sham or tolterodine in improving symptoms of overactive bladder after a 12 week treatment with PTNS. One additional small study has suggested an added benefit of adding neuromodulation to anti-muscarinic therapy at short term follow-up. Two small studies of initial responders has shown that treatment benefit continues up to 24 months, although neither study had a comparison group that did not receive ongoing PTNS. SURx Transvaginal System The SURx Transvaginal System is a radiofrequency device that has been specifically designed as a transvaginal treatment of urinary stress incontinence. An incision is made through the vagina lateral to the urethra, exposing the endopelvic fascia. Radiofrequency energy is then applied over the endopelvic fascia, resulting in blanching and shrinkage of the tissue. There is insufficient evidence to conclude that transvaginal radiofrequency therapy is effective for treating urinary incontinence. Studies report low cure rates and high rates of additional corrective treatment. A draft assessment by the California Technology Assessment Forum (2008) on RF micro-remodeling for the treatment of female SUI stated that RF micro-remodeling with the SURx System (paraurethral or transvaginal) does not meet its criteria for safety, effectiveness and improvement in health outcomes for the treatment of female SUI. Scientific Rationale January 2012 Pelvic Floor Muscle Training Yamanishi et al. (2010) completed a randomized double-blind trial. Electrical stimulation was compared to a sham-control group. This trial, conducted in Japan, in which 56 men with severe urinary incontinence and post-prostatectomy were randomized to receive active (n=26) or sham (n=30) electrical stimulation. All men performed pelvic floor muscle training. Active or sham electrical stimulation was performed until incontinence was resolved or until the end of the study. A total of 47 patients (22 in the active stimulation group and 25 in the sham group) completed the 12-month study. The continence rate, defined as loss of 8 gm or less or urine during a 24-hour pad test, was the primary efficacy outcome. There was a statistically significantly higher rate of continence at 1, 3 and 6 months in the active stimulation group compared to the sham group but the difference between groups was not statistically significant at 12 months. Rates of continence in the active electrical stimulation group were 8 (36%), 14 (63%), 18 (81%) and 19 (86%) at 1, 3, 6 and 12 months respectively. Corresponding rates in the sham group were 1 (4%), 4 (16%), 11 (44%) and 17 (86%). Findings of the 24-hour pad tests were also reported in several other ways. Differences in the amount (number of grams) of daily leakage were not significantly different between groups at any follow-up time point. For example, after one month, the mean amount of leakage was 210 gm in the active treatment group and 423 in the sham group, p>0.05. Change in the amount of daily leakage from baseline differed significantly between groups at 1 Urinary Incontinence Devices and Treatments Oct 15 16

17 month (-528 gm in the active treatment group and -257 gm in the sham group, p<0.01) but not at the other follow-up time points. Goode et al. (2010) completed a randomized trial comparing behavioral therapy alone to behavioral therapy in combination with biofeedback and pelvic floor electrical stimulation. The trial included 208 men with urinary incontinence persisting at least 1 year after radical prostatectomy. Men with pre-prostatectomy incontinence were excluded. Participants were randomized to one of 3 groups; 8 weeks of behavioral therapy (pelvic floor muscle training and bladder control exercises) n=70), behavioral therapy plus biofeedback and electrical stimulation (n=70) and a delayed-treatment control group (n=68). The biofeedback and electrical stimulation intervention, called behavior-plus, consisted of in-office electrical stimulation with biofeedback using an anal probe and daily home pelvic floor electrical stimulation. After 8 weeks, patients in the 2 active treatment groups were given instructions for a maintenance program of pelvic floor exercises and fluid control and were followed up at 6 and 12 months. The primary efficacy outcome was reduction in the number of incontinent episodes at 8 weeks as measured by a 7-day bladder diary. A total of 176 of 208 (85%) of randomized men completed the 8 weeks of treatment. In an intention-to-treat analysis of the primary outcome, the mean reduction in incontinent episodes was 55% (28 to 13 episodes per week) in the behavioral therapy group, 51% (from 26 to 12 episodes per week) in the behavior-plus group and 24% (from 25 to 20 episodes per week) in the control group. The overall difference between groups was significantly significant (p=0.001) but the behavior-plus intervention did not result in a significantly better outcome than behavioral therapy alone. Findings were similar on other outcomes. For example, at the end of 8 weeks, there was a significantly higher rate of complete continence in the active treatment groups (11 of 70, 16% in the behavior group and 12 of 70, 17% in the behavior-plus group) than the control group (4 of 68, 6%), but the group receiving biofeedback and electrical stimulation did not have a significantly higher continence rate than the group receiving behavioral therapy alone. The study did not isolate the effect of pelvic floor electrical stimulation. However, the combined intervention of biofeedback and electrical stimulation along with behavioral therapy did not result in better outcomes than behavioral therapy alone. Vaginal Weight Training Vaginal weight training is a behavioral therapy that employs weights during Kegel or pelvic floor exercises to strengthen pelvic floor muscles. The use of vaginal weights (cones) has not been shown to improve pelvic floor muscle strength more than Kegel exercises alone. Vaginal weight training involves the use of small, specially designed weights ("cones") that a woman may place in the vagina and hold there, to strengthen the muscles in the pelvic area. Over time, increasingly heavier weights are used and this is thought to increase muscle strength. The vaginal cones are made from surgical grade stainless steel surrounded by a double welded plastic case. They are smooth with a plastic coated retrieval cord. Pelvic muscle exercises (PME) training can be supplemented by the use of weighted vaginal cones, which a patient inserts in her vagina and uses pelvic muscle contractions to hold in place during activity. Small trials in younger women show efficacy compared with no treatment, but it is unclear whether outcomes are comparable to other behavioral therapies Gameiro et al. (2010) completed a study in which 103 incontinent women were randomly distributed into two groups: group G1 (n = 51) treated with VWC and G2 Urinary Incontinence Devices and Treatments Oct 15 17

18 (n = 52), APFMT. The following parameters were performed initially and after treatment: (1) clinical questionnaire, (2) visual analogue scale (VAS), (3) 60-min pad test, and (4) subjective and objective assessment of pelvic floor muscle (PFM). There was a significant decrease in nocturia and urine loss after treatment in both groups (p < 0.05). In VAS, there was a significant improvement of all parameters in both groups (p < 0.05). The pad test showed significant decrease in both groups (p < 0.05). There was a significant increase of PFM strength in both groups (p < 0.05). There was no difference between groups treated with VWC and APFMT. Scientific Rationale September 2011 Garneiro et al (2010) compared vaginal weight cone (VWC) versus assisted pelvic floor muscle training (APFMT) in the treatment of urinary incontinence (UI) in women. One hundred three incontinent women were randomly distributed into two groups: group G1 (n = 51) treated with VWC and G2 (n = 52), APFMT. The following parameters were performed initially and after treatment: clinical questionnaire, visual analogue scale (VAS), 60-min pad test, and subjective and objective assessment of pelvic floor muscle (PFM). There was a significant decrease in nocturia and urine loss after treatment in both groups (p < 0.05). In VAS, there was a significant improvement of all parameters in both groups (p < 0.05). The pad test showed significant decrease in both groups (p < 0.05). There was a significant increase of PFM strength in both groups (p < 0.05). The investigators concluded there was no difference between groups treated with VWC and APFMT. Santos et al (2009) compared the effects of functional electrostimulation of the pelvic floor and therapy with cones in women with stress urinary incontinence (SUI) in a randomized clinical study of 45 patients with SUI. The effects of functional electrostimulation of the pelvic floor were evaluated in the SUI treatment of 24 women, with the use of clinical data (micturition diary, pad test and a questionnaire about quality of life - I-QoL). The patients were submitted to two 20' weekly sessions for four consecutive months, under the supervision of a physiotherapist. The electrode used had 10 cm length and 3.5 cm width with a double metallic ring and a cylindrical shape, positioned in the medium third of the vagina. The electric parameters used were: intensity varying from 10 to 100 ma and 50 Hz of fixed frequency, with pulse duration of 1 ms. Also, 21 patients who were submitted to vaginal cone treatment were evaluated. The cone therapy was done with two 45 minute sessions per week. The cones' weight varied from 20 to 100 gr. There was no difference between the outcomes of electrostimulation of the pelvic floor and the vaginal cones for the treatment of SUI (p>0.05). After four months, there was a significant improvement in the I-QoL index of the patients treated both with electrostimulation (40.3 versus 82.9) or with the cones (47.7 versus 84.1). There was a significant decrease in pad weight in both groups, measured before and after the treatment (28.5 and 32 g versus 2.0 and 3.0 g for the electrostimulation and cone group, respectively). Finally, there was a significant decrease in the number of urinary leakage evaluated by the micturition diary in both groups (p<0.0001). The investigators concluded both electrostimulation and vaginal cones were effective in the treatment of women with SUI. Eyjólfsdóttir H et al (2009) compared the effectiveness of pelvic floor muscle training with and without electrical stimulation in treatment of stress urinary incontinence in 24 women, years of age, diagnosed with stress urinary incontinence. Exclusion criteria were pregnancy and urge urinary incontinence. Participants were randomly divided into group 1 and 2. Both groups trained 15 min. twice a day for 9 weeks. Group 2 used simultaneously intermittent electrical stimulation. The pelvic floor Urinary Incontinence Devices and Treatments Oct 15 18

19 muscles were evaluated using the Oxford scale, vaginal palpation, and by electromyogram, (Myomed 930, Enraf Nonius). The quantity and frequency of urinary incontinence episodes was evaluated using a questionnaire and a VAS scale before and after the treatment. The groups were demographically similar, except group 2 was significantly younger. Both groups had significantly increased pelvic floor muscle strength (p=0.007; p=0.005 respectively) after the treatment and 70% of all the women had reduced or no stress urinary incontinence. Group 2 had significantly (p=0.013) better relaxation post treatment. The investigators concluded pelvic floor muscle training is an effective treatment for stress urinary incontinence, but electrical stimulation gave no additional effect for this patient group. The significantly lower relaxation threshold in group 2 indicates that electrical stimulation could be a possible treatment for symptoms caused by hypertensive pelvic floor muscles. Scientific Rationale November 2010 The Centers for Medicare and Medicaid (CMS) does not have a National Coverage Determination (NCD) for transurethral radiofrequency (RF) energy therapy for stress urinary incontinence (SUI) in women. Several local Medicare carriers have begun to provide coverage of transurethral RF energy therapy for the treatment of SUI in women who have failed conservative treatment, do not wish or are not candidates for surgical procedures and do not have structural abnormalities that would contraindicate the procedure. Physicians performing the procedure must have proof of adequate training (either a certificate from the manufacturer or equivalent certification.) The available evidence on the efficacy and safety of transurethral radiofrequency therapy with the Renessa system for treatment of SUI continues to be limited. No new studies evaluating the long-term safety and efficacy of the Renessa procedure for the treatment of stress urinary incontinence was identified in the current literature. In addition, no studies comparing this technique to other standard therapies was idenitifed. Although the data collected to date suggests that radiofrequency treatment of SUI has promising efficacy and entails a minimal risk of adverse events, further prospective randomized studies with longer follow-up are needed to assess the ultimate role of this procedure. CMS has National Coverage Decisions (NCD) regarding various treatments for urinary incontinence, including biofeedback, sacral nerve stimulation and non-implantable pelvic floor electrical stimulators. CMS does not have a NCD regarding urethral inserts (e.g. Femsoft). Several local Medicare carriers have local coverage determination s on urological supplies. These LCD s state, effective 1/1/2010, There are no indications for which urethral inserts (A4336) have been demonstrated to have any therapeutic effect. Claim lines billed with this code will be denied a not medically necessary. More recently, however, effective 9/2/2010, CMS issued an article regarding urethral inserts, noting the inserts would be covered when criteria is met. Scientific Rationale February 2009 Two radiofrequency devices, the SURx Transvaginal System and the Renessa System, are FDA approved for the treatment of stress urinary incontinence. Transurethral radiofrequency therapy with the Renessa system is typically undertaken in outpatient surgery under conscious sedation; however, data suggests that the procedure may be performed in the office using oral sedatives and local anesthetics. The available evidence on the efficacy and safety of transurethral Urinary Incontinence Devices and Treatments Oct 15 19

20 radiofrequency therapy with the Renessa system for treatment of SUI continues to be limited. In addition, much of the available published literature comes from the same group of investigators. In a prospective randomized trial sponsored by the manufacturer, Novasys Medical Inc, Appell et al (2006) investigated the 12 month safety and efficacy of transurethral radiofrequency energy (RF) collagen microremodeling in women with stress urinary incontinence (SUI). 173 non-pregnant women with SUI, bladder outlet hypermobility, and leak point pressure (LPP) > 60 cm H2O were randomized to RF micro-remodeling (n=110) or sham treatment (n=63) in which all but the actual delivery of the RF energy was the same. The subjective outcome was based on a validated incontinence quality of life (I-QOL) score. Incidence of > 10 point I-QOL score improvement, a magnitude of improvement with a demonstrated responsiveness to patient satisfaction with treatment and to > 25% reduction in both incontinence episode frequency and stress pad weight, served as a subjective outcome measurement. The objective outcome measure was leak point pressure (LPP) in which the clinician/investigator measures the minimal abdominal pressure required to drive urine across the urethral sphincter. An increase in LPP is considered an improvement (decrease) in SUI. Patients were blinded to treatment group, however, there was no mention of investigator blinding. There was a loss to follow-up of nearly 20%. The 12 months RF micro-remodeling safety profile was statistically no different than that of sham treatment. At 12 months, there was no difference in the percentage of RF versus sham recipients who achieved a > 10-point improvement in I-QOL score at 12 months (48% versus 44%, respectively). When patients were retrospectively stratified by baseline I-QOL scores, RF recipients with moderate to severe baseline SUI experienced > 10 point I- QOL score improvement. At 12 months, RF recipients demonstrated LPP elevation, while sham treated women demonstrated LPP reduction. Although the results indicate a positive treatment effect in severe cases of SUI supported by the LPP results, the study is limited by the retrospective stratification of the patient group to obtain a statistically significant difference in QOL score improvements in the face of high placebo response rates, loss to follow-up of nearly 20%, and lack of investigator blinding. Other small studies have investigated the Renessa system, however, they have been small, uncontrolled trials with lack of any long-term data regarding safety and efficacy. There also lacks large randomized controlled trials that compare this technique to other standard therapies. A Tec assessment by the California Technology Assessment Forum (CTAF) concluded While RF micro-remodeling (Renessa) for SUI does not show as high success rates as the gold standard approaches (Burch and tension-free vaginal tape), it does demonstrate a good safety profile and moderate improvement in objective urinary leakage and quality of life, particularly for women with moderate to severe SUI. The CTAF states that some questions remain, including whether there is drop-off in improvement over time and how much, and whether women who undergo RF microremodeling (Renessa) can subsequently undergo other SUI procedures such as the Burch and TVT without undo complication, and confirmation in larger studies that RF micro-remodeling (Renessa) can be comfortably undergone as a simple office procedure with local anesthesia and oral analgesia/sedation. The CTAF concluded that the Renessa system meets criteria for safety, effectiveness and improvement in health outcomes for the treatment of moderate to severe female stress urinary incontinence in non-pregnant women who are either not able or not willing to undergo surgery for their SUI treatment. Urinary Incontinence Devices and Treatments Oct 15 20

21 Investigators are also researching the use of RF energy to stabilize pelvic muscles using a transvaginal approach. In this procedure, performed under general anesthesia, an incision is made through the vagina and RF energy applied in a sweeping motion over the endopelvic fascia to shrink and stabilize the tissue, improving the support for the urethra and bladder neck (Surx RF System, Surx Inc). Per its FDA 510(k) clearance, the SURx Transvaginal System is indicated for shrinkage and stabilization of female pelvic tissue for treatment of Type II stress urinary incontinence due to hypermobility in women not eligible for major corrective surgery. The available literature addressing this technique is even more limited. Ismail (2008) investigated this technique in a small study of 24 women. He noted a rising failure rate as early as 3 months following the procedure. Buchsbaum et al (2007) reported similar findings in a retrospective chart review of 18 women treated with the transvaginal radiofrequency bladder neck suspension. The investigator reported a low cure rate, low patient satisfaction, and a high rate of additional treatment was necessary. The CTAF Tec assessment reported that RF micro-remodeling using the SURx system has not been directly compared to either a sham procedure or a gold-standard surgical approach to SUI, nor has it been studied in an RCT. They recommended that radiofrequency micro-remodeling with the SURx system does not meet CTAF criteria for safety, effectiveness and improvement in health outcomes for the treatment of female stress urinary incontinence. An ACOG practice bulletin on urinary incontinence in women does not address the use of radiofrequency remodeling. They note treatment of SUI may include behavioral modification, pelvic floor therapy, bulking agents, tension free vaginal tape and surgical repair (e.g., retropubic colposuspension, sling procedures) At this time there is minimal evidence in the peer-reviewed literature that demonstrates the efficacy and long-term effectiveness of transvaginal radiofrequency surgery or transurethral radiofrequency tissue micro-remodeling in the treatment of stress urinary incontinence. Scientific Rationale Update December 2008 A biological urinary sphincter prevents urinary flow by mucosal coaptation, compression, and pressure transmission. An artificial urinary sphincter (AUS) is the only device that closely simulates the function. The AUS mimics the biological urinary sphincter by providing a competent bladder outlet during urinary storage and an open unobstructed outlet to permit voluntary voiding. This device is reserved for treatment of complex or severe stress urinary incontinence, known as type III stress urinary incontinence, or intrinsic sphincteric dysfunction, which is the inability of the urethra to maintain effective resting urethral closure pressure, sufficient to keep the patient clinically dry at rest and during periods of reasonable physical activity. Patients with intrinsic sphincteric dysfunction include men with a history of radical retropubic or perineal prostatectomy or transurethral resection of the prostate (TURP); patients with previous pelvic trauma or a history of pelvic radiation; patients with spinal cord injuries, myelomeningoceles, or other causes of neurogenic bladder. All individuals must understand the potential complications of the operation and the possibility of future surgical interventions for tissue atrophy, cuff erosion, cuff migration, mechanical failure, and device infection. Long-term reoperation rate is about 20%. Urinary Incontinence Devices and Treatments Oct 15 21

22 The AMS 800 (American Medical Systems, Minnetonka, Minn) device has received a summary of safety and effectiveness, by the US FDA on June 14, 2001, for this device. The AMS 800 artificial urinary sphincter is composed of a pressure-regulatin balloon, an inflatable cuff, and a control pump. The balloon has a dual function: it is a pressure regulator and a fluid reservoir. Balloon reservoirs come in 5 preset pressures 41-50, 51-60, 61-70, 71-80, and cm water. The lowest pressure required to close the urethra is used. Balloon reservoirs typically are placed in the lower abdomen. For uncomplicated bulbar urethral cuffs, the most commonly chosen balloon reservoirs are the ones with preset pressures of and cm water. For bladder neck cuffs, the balloon reservoir with pressures of cm water is chosen because higher pressures are necessary to occlude the bladder neck. Patients with prior radiation or surgical changes that present a higher risk of erosion may benefit from a cm water reservoir. The inflatable cuff has a variable length that compresses the urethra or the bladder neck circumferentially. Cuff sizes range from 4-11 cm, in 0.5-cm increments. The cuff is placed around the bulbar urethra in adult males. The control pump contains unidirectional valves, a delayed-fill resistor, a locking mechanism, and a deflate pump. The control pump is small and easily concealed within a subcutaneous or dartos pouch in the scrotum or the labia. The delayed-fill resistor is responsible for automatic cuff refilling. The cuff inflation takes 3-5 minutes, although bladder emptying takes less time. A unique feature of this model is the locking mechanism that can keep the cuff deflated for a prolonged period. The locking mechanism is a small button located on the side of the control pump. To void, the patient must open the artificial sphincter. The patient manually squeezes the control pump that is located in the scrotum or the labia. When the control pump is squeezed, the fluid in the control pump is sent up to the balloon reservoir. The control pump then automatically reexpands; as it reexpands, it pulls the fluid out from the cuff, which causes the sphincter cuff to deflate. The patient repeats this maneuver 3-4 times until the pump remains flat, which indicates that the cuff is completely empty. At this point, the urine flows freely from the bladder. Urination continues until the bladder is empty. After 3-5 minutes, the fluid from the balloon reservoir automatically flows through a delayed-fill resistor within the pump and down back to the cuff. When the cuff reinflates, the urethra becomes effectively closed and the patient becomes dry. The locking mechanism (button on the side of the control pump) allows the physician to lock the cuff in an open or closed position. Typically, the AMS 800 device is left locked (deactivated) in an open position at the time of surgical implantation to allow for adequate tissue healing and is unlocked in the physician's office 6-8 weeks after operation. If the patient inadvertently locks the button when the cuff is closed, urinary retention occurs. Conversely, if the button is locked when the cuff is open, persistent incontinence occurs. Patients should be instructed on the locking mechanism to understand and be able to respond to these problems. Patients with intrinsic sphincteric dysfunction present with the classic history for stress urinary incontinence. They experience predictable loss of urine whenever the intravesical pressure exceeds that of the urethral pressure (eg, when coughing, laughing, sneezing, sitting down, or performing the Valsalva maneuver). Intrinsic sphincteric dysfunction can often be distinguished from other causes of incontinence by patient history and physical examination. For patients with pure intrinsic sphincteric dysfunction, symptoms of urinary frequency, urgency, and nocturia are typically absent. However, when irritative voiding symptoms are also present, coexisting overactive bladder should be suspected. As such, patients should undergo preoperative endoscopic and urodynamic evaluations Urinary Incontinence Devices and Treatments Oct 15 22

23 Simon et al. (2005) presented the results of 47 patients from 1990 to 2003, who had AMS 800 inserted by the same operator and according to the same technique. The etiologies of urinary incontinence were: radical prostatectomy (45% of cases), transurethral resection of the prostate (36%), open prostatectomy (10.5%), and others (8.5%). The mean age of the patients was 65 years. The mean follow-up was 36 months. 23.4% of patients presented one or several complications (mechanical failure: 19%; infection; 10.6%; erosion: 4%; bladder stones: 2%), 21% of patients required one or several surgical revisions after a mean interval of 25.5 months (range: 2-80 months). The actuarial 5-year revision rate was 25.5%. With a mean follow-up of 36 months, 98% of patients had a functioning artificial urinary sphincter and 83% still had their original artificial urinary sphincter. These results are comparable to those of similar published series. The AMS 800 is associated with high continence and patient satisfaction rates and currently remains the reference treatment for refractory sphincter incompetence in men. Ramsay et al. (2007) assessed patient satisfaction and continence post operatively as well as complication rate and need for revision or replacement surgery in a retrospective single center study over a ten year period. The study included thirtyeight male patients and 1 female patient that had an AMS 800 AUS inserted. The investigator reported that five patients have required replacement surgery to date. Male patients were divided into two groups according to the etiology of their incontinence: neuropathic (n = 11) and non-neuropathic (n = 27). Social continence was achieved in all patients. Three non-neuropathic patients developed complications. Revision surgery was undertaken in 4 of non-neuropathic patients and in 1 neuropathic patient. The mean lifespan of the AUS in patients who required further surgery is 6.6 years. The author concluded that patients with severe sphincter weakness incontinence, the AMS 800 AUS is a safe and reliable solution. They noted that their results are comparable with previous published studies of larger patient numbers from dedicated reconstructive units. O'Connor et al (2007) investigated the outcomes of AUS for the treatment of postprostatectomy stress urinary incontinence in 33 patients aged 75 years or older at the time of surgery. Four patients were lost to follow-up and were excluded from the analysis. The average follow-up was 5.0 years. After AUS insertion, the mean pad use improved from 6.7 (range 3 to 10) to 0.8 (range 0 to 2) per day. Overall, 16 of 29 men reported no complications. AUS revision was necessary in 4 men and sphincter removal in 4. Six men required deactivation of the implant because of poor overall health an average of 47 months after placement. The "success" rate improved to 72% when cuff deactivation without revision or removal was not considered a complication. The investigators concluded that elderly men did well after AUS placement for postprostatectomy stress urinary incontinence and the procedure should not be withheld solely on the basis of the age of the patient. Success with the AUS for the treatment of post prostatectomy incontinence (PPI) is generally excellent, with continence rates between 75% and 90% in most modern series and patient satisfaction rates of 85% to 95% despite revisions. Since the modification of the AMS 800 in 1987 to include the narrow-backed cuff, success has improved and complications have diminished, particularly with respect to urethral erosion and atrophy. The largest series to date was presented by investigators at the Mayo Clinic, who reported that in 323 patients with a mean follow-up of nearly 6 years, 90% of patients were alive with a well-functioning AUS. Revision rate was 42% prior to the development of the narrow-backed cuff (21% mechanical failure, Urinary Incontinence Devices and Treatments Oct 15 23

24 17% nonmechanical failure) but decreased to 17% when using the narrow-backed cuff (8% mechanical failure, 9% nonmechanical failure). In a report of patients with at least 10-year follow-up, an excellent continence rate of 75% was realized, despite a revision rate of 80%. Other groups have reported similar excellent continence at a minimum of 10 years' follow-up, with 84% of 100 patients remaining continent, with two thirds requiring at least one revision (27% due to mechanical failure and 21% due to nonmechanical failure. After appropriate diagnostic workup, surgery is often elected by those patients with bothersome sphincteric incompetence who fail conservative management, such as treatment with collagen bulking injections or male sling procedures. With the continuing popularity of prostate cancer screening, post-prostatectomy incontinence remains the most common indication for AUS placement. AUS has been the gold standard treatment for post-prostatectomy incontinence, with excellent patient satisfaction despite the need for approximately 20% operative revision. However, recent modifications of the male sling, resulting in intermediate-term success rates have rendered the perineal bone-anchored male sling a viable alternative for the treatment of PPI. (2006) According to the Canadian Urological Association guidelines on urinary incontinence, AUS is the treatment of choice in neurogenic and non-neurogenic SUI in men. Scientific Rationale Update September 2006 Posterior tibial nerve stimulation (PTNS) also commonly referred to as percutaneous tibial neuromodulation (PTN) has been proposed as a minimally invasive alternative treatment option for patients with lower urinary tract dysfunction, such as urge incontinence or urgency/frequency. The posterior tibial nerve is a mixed sensorymotor nerve containing fibers originating from spinal roots L4 through S3, comprising the outflow of the sacral nerves, which modulate the somatic and autonomic nervous supply to the pelvic floor, innervating directly the bladder and urinary sphincter. Unlike sacral nerve stimulation, percutaneous tibial nerve stimulation does not require implantation of a permanent device. 510k clearance from the FDA has been given for the Stoller Afferent Nerve Stimulator (PerQ SANS) and the Urgent PC Stimulator. These devices are designed for use in an office setting and consists of a small 34-G needle electrode, surface electrode, lead wire and handheld electrical generator. The percutaneous needle is inserted approximately 5cm cephalad to the medial malleous. The stimulator produces an adjustable electrical pulse that travels up to the sacral nerve plexus via the tibial nerve. Amplitude is then reduced slightly and treatment is continued for 30 minutes. Per the manufacturer of the Urgent PC Stimulator, significant reductions in urge frequency and intensity have been observed after approximately 12 weeks without any significant adverse effects. The manufacturer states that once symptoms have abated, treatment frequency may be reduced. If symptoms reappear or increase in severity, the last previously effective treatment schedule should be reinstated. Van der Pal et al. investigated the relationship between quality of life (QoL) and voiding variables in patients with lower urinary tract dysfunction treated with percutaneous tibial nerve stimulation (PTNS). The study included 30 patients with urge urinary incontinence who were treated with PTNS; 24-h bladder diaries and QoL questionnaires were completed at baseline and after PTNS. The investigator concluded that PTNS may be useful for treating refractory urge incontinence and should at least be considered as a therapeutic alternative before resorting to Urinary Incontinence Devices and Treatments Oct 15 24

25 aggressive surgery. Patients must have a reduction of >or = two pads/day before their QoL improves, and per the investigator, this might be the best definition of successful therapy for patients with urge urinary incontinence. Finazzi et al. investigated PTNS performed weekly in patients with overactive bladder syndrome to those of PTNS performed 3 times per week. Thirty-five patients (28 females, 7 males) with overactive bladder syndrome not responding to antimuscarinic therapy were included in this randomized prospective study. 17 patients in group A were randomly assigned to receive PTNS on weekly stimulation sessions while the remaining 18 patients in group B received the treatment 3 times weekly. All subjects were evaluated by means of 24 h bladder diaries, quality of life questionnaires and urodynamic evaluation before and after treatment. Patients were asked after each stimulation session to give their opinion on the efficacy of the treatment. The author considered ''success'' in patients who presented a reduction >50% of the micturition episodes or incontinence episodes/24 h. Results before and after treatments in both groups were collected and statistically compared. The investigator found that as a whole, 11/17 patients (63%) in group A and 12/18 patients (67%) in group B were considered ''success''; 4/11 (36%) incontinent patients in group A and 5/11 (45%) incontinent patients in group B were completely cured after treatment. In both groups, patients reported subjective improvement after 6-8 stimulation sessions. The author concluded that the findings seem to show that the periodicity of stimulation does not effect the results of PTNS treatment. The advantage of more frequent stimulation sessions is to achieve earlier a clinical improvement. Degennaro et al. evaluated pain tolerability and the preliminary results of percutaneous tibial nerve stimulation (PTNS) in 23 children with unresponsive lower urinary tract symptoms, refractory to conventional treatment. Each had 30-minute weekly sessions for 12 weeks. Evaluation was done at the first, sixth and last sessions. All 23 children underwent clinical and urodynamic evaluation before and after treatment. All but one completed the treatment. The investigator concluded that PTNS was safe, minimally painful and feasible in children. Hoebeke et al tested 18 weekly sessions of PTNS using the SANS device among 32 children (mean age 11.7, 46% female) with nonneuropathic bladder sphincter dysfunction refractory to a variety of prior treatments. Urinary urgency disappeared in 25% of the children, and improved in another 36%. Of 23 children who complained of pretreatment incontinence, 17% became dry and 52% enjoyed improvement in terms of frequency or volume. Urodynamic parameters also improved: 9 of 21 patients with abnormal uroflowmetry curves before treatment normalized after treatment, and mean bladder capacity increased from 185 to 279 ml. Krivoborodov GG et al investigated PTNS in 36 patients with overactive bladder. Again, patients were treated for 30 minutes weekly for 12 weeks. An objective effect was analysed by urodynamic studies. A decrease in the average voiding frequency, number of leakage episodes and pad use per 24 hours after 12 sessions of the stimulation was noted. Symptomatic improvement of more than 50% was achieved in 28 of 36 patients leading the investigator to conclude that stimulation of the posterior tibial nerve is effective in patients with overactive bladder. Govier et al reported the only prospective, multicenter United States experience with the SANS device. Fifty-three patients (90% women) with overactive bladder (OAB) refractory to standard medical treatments were treated with 12 weekly bilateral SANS sessions. Eighty-nine percent of patients completed the study. Seventy-one Urinary Incontinence Devices and Treatments Oct 15 25

26 percent of patients overall met the study goal of a greater than or equal to 25% reduction in diurnal or nocturnal urinary frequency, with mean reductions in diurnal, nocturnal, 24-hour, and excess (>10 episodes per day) frequency of 25%, 21%, 22%, and 70%, respectively. On standardized questionnaires administered during the study, participants reported a mean 35% improvement in urge incontinence episodes, a 30% improvement in pain, and a 20% improvement in incontinencerelated quality of life. No serious adverse events were reported. Finally, in a prospective multicenter trial (van Balken et al, 2001) posterior tibial nerve stimulation was evaluated in 37 patients who presented with symptoms of bladder overactivity (i.e., urgency and frequency) and/or urge incontinence, and 12 with nonobstructive urinary retention. Overall, a positive response was seen in 60% of all patients. In patients with bladder overactivity a statistically significant decrease was observed in leakage episodes, number of pads used, voiding frequency and nocturia, and an equal increase in mean and smallest volume voided. Improvements were also seen in nonobstructive urinary retention, including number of catheterizations, total and mean volume catheterized, and total and mean volume voided. Disease specific quality of life and some domains of general quality of life improved, especially of bladder overactivity. Only mild side effects were observed. The investigator concluded that PTNS is a minimally invasive and successful treatment option for patients with certain types of lower urinary tract dysfunction. Peripheral neuromodulation is a technology still in the relatively early stages of development. Small published studies have been promising, with a wide variation in degrees of success, even when they used relatively objective measures, such as diary-assessed frequency of incontinence episodes. Fewer patients may respond to peripheral than to sacral neuromodulation. Their exists a need for more randomized, controlled trials that use standardized, validated HRQOL questionnaires in addition to diaries and uroflowmetry studies. The additional benefit beyond 12 weekly treatment sessions, the potential use of more frequent stimulation, and the ultimate durability of responses are some questions regarding PTNS that have not yet been answered definitively. Scientific Rationale Update May 2006 The Renessa System has been proposed as a therapeutic option in the treatment of stress urinary incontinence. The Renessa procedure uses radiofrequency energy to generate controlled heat at low temperatures in tissue targets within the lower urinary tract. This procedure can be performed in the physcians office using local anesthesia and utilizes a single-use, hand-held, balloon-tip probe, which is attached to a generator. The probe has four deployable needles that applies controlled heat to tissue targets within the lower urinary tract, and delivers heat using a low temperature radiofrequency (65 degrees Centigrade) so tissue is not burned or melted. The heat causes the collagen in that area to separate and denature, tightening the area and resulting in less give. Per the manufacturer, this increases resistance to involuntary leakage at times of heightened intra-abdominal pressure, such as laughing, coughing or during exercise, thereby reducing or eliminating SUI episodes. FDA indications include those who have failed conservative care and are not candidates for surgical therapy. A Medline search of the peer review literature lacks any published long term clinical studies to determine the safety and effectiveness of this procedure. In addition, there also lacks any published clinical studies that compare the efficacy of this procedure to other treatment options for stress urinary incontinence. As such, this treatment remains unproven and investigational. Urinary Incontinence Devices and Treatments Oct 15 26

27 Initial Scientific Rationale for Femsoft Insert Urinary incontinence (the involuntary loss of urine) is a medical problem that impacts the lives of millions of women of all ages, most of whom have stress urinary incontinence. In women between the ages of 15 and 64 years, the incidence of incontinence can be as high as 30 percent. Stress urinary incontinence is marked by the involuntary leakage of urine during coughing, laughing, sneezing, or other physical activities that increase pressure on the bladder. The FemSoft Insert is a single use, self-inserted, intra-urethral device composed of a narrow silicone tube entirely encased in a soft, thin, mineral oil-filled sleeve. The silicone sleeve forms a balloon on its tip of the catheter. On the opposite end, the catheter and sleeve to form a soft, oval-shaped external retainer. A disposable applicator is used to provide a means for insertion. The insert comes in various sizes and lengths and needs to be properly fitted. When the insert is advanced into the urethra, the fluid in the sleeve flows toward the external retainer to facilitate the insert's passage through the urethra. When the tip of the FemSoft Insert has entered the bladder, the fluid automatically returns to fill the balloon, creating a seal at the bladder neck and urethra. The fluid-filled sleeve readily adjusts to anatomical variations among women. The sleeve further adjusts to changes in urethral shape that occur with body movement and/or changes in intraabdominal pressure. This feature allows the insert to maintain constant contact with the urethral tissues, thereby preventing urine leakage. The insert should be replaced at least once every six hours and at night to reduce the chance of adverse events. The FDA approved the FemSoft Insert in 1999 based on the results of a multi-center clinical study involving 150 women. Forty two percent of the women had prior treatment for their incontinence including pelvic exercises, surgical procedures or pharmacological agents, Study parameters included incontinence history, physical examination, urinalysis, urine culture, pad weight test, voiding diaries, QOL questionnaires, cystometries and cystoscopies and abdominal leak point pressure measurements. Adverse events reported during the first year of the study included: bacteriuria >100,000 CFU (30%), symptomatic UTI (24%), urinary symptoms (23%), insertion trauma (6%), device performance (5%) and bladder/urethral trauma (3%). Scientific Rationale for Urinary Incontinence Devices and Treatments - Initial Urinary incontinence (UI), or the unintentional loss of urine, is a medical problem for more than 13 million Americans 85% of them are women. In women between the ages of 15 and 64 years, the incidence of incontinence can be as high as 30 percent because of weakened pelvic muscles. When the loss of urine is frequent enough or severe enough, it can become a social or hygiene problem. Older men can become incontinent as the result of prostate surgery. Pelvic trauma, spinal cord damage, caffeine, or medications including cold or over-the-counter diet tablets also can cause episodes of incontinence. There are four common types of incontinence: (1) stress incontinence, resulting from urethral sphincter failure due to either an anatomic changes or intrinsic sphincter deficiency (ISD), is marked by the involuntary leakage of urine during coughing, Urinary Incontinence Devices and Treatments Oct 15 27

28 laughing, sneezing, or other physical activities that increase pressure on the bladder; (2) urge incontinence, usually a result of detrusor instability, is caused by a sudden, involuntary bladder contraction or involuntary sphincter relaxation and is more common in older adults; (3) mixed incontinence is a combination of both stress and urge incontinence, and is most common in older women; (4) overflow incontinence results from bladder obstruction or injury together with hypotonic detrusor activity secondary to drugs, fecal impaction, diabetes, lower spinal cord injury, disruption of the motor innervation of the detrusor muscle, urethral obstruction or genital prolapse, where the bladder becomes too full because it can't be fully emptied; it is rarer and can be the result of an enlarged prostate. The three major categories of treatment for urinary incontinence are behavioral, pharmacologic, and surgical. In general, the first choice should be the least invasive treatment with the fewest potential adverse complications for the patient. Before treatment commences, a complete evaluation and appropriate urodynamic testing should be completed. The goal of behavioral treatment is to help a woman understand why leakage occurs and how to avoid it. Behavior modification treatment may include bladder retraining, Kegel exercises and biofeedback. For urge or mixed incontinence, "retraining" the bladder to resist the urge to void by going to the bathroom at specific times, such as every hour on the hour or every two hours and increasing the time between urinations, may help avoid accidents. For moderate stress incontinence in women, Kegel exercises may be helpful as the urinary sphincter, with the help of surrounding pelvic floor muscles, controls release of urine from the bladder. These involve contracting the pelvic muscles several times a day for 3 to 6 months. Kegel exercises also can be used with or without biofeedback. Biofeedback is a process that helps a patient to control body functions by providing immediate information about the body's responses. Periodic drainage of the bladder with a catheter may be necessary for some people. Specific drugs are available to improve storage or emptying of the bladder and, depending on the problem, may be useful. Medications used to help prevent urine leakage include drugs that control bladder spasms, such as oxybutynin (Ditropan) or tolterodine (Detrol); drugs that strengthen the smooth muscle of the urethra, such as alpha-blockers; antibiotics to treat incontinence that is related to a urinary tract infection; and conjugated estrogens (in postmenopausal women) to improve the elasticity of pelvic muscles and surrounding tissues. Unfortunately, pharmacologic agents rarely are effective, and, when they are effective, adverse effects diminish the results. Behavior and dietary modifications have a rather limited role in the treatment of UI. The FemSoft Insert is a single use, self-inserted, intra-urethral device composed of a narrow silicone tube entirely encased in a soft, thin, mineral oil-filled sleeve. The silicone sleeve forms a balloon on its tip of the catheter. On the opposite end, the catheter and sleeve to form a soft, oval-shaped external retainer. A disposable applicator is used to provide a means for insertion. The insert comes in various sizes and lengths and needs to be properly fitted. The FDA approved the FemSoft Insert in 1999 based on the results of a multi-center clinical study involving 150 women. Forty two percent of the women had prior treatment for their incontinence including pelvic exercises, surgical procedures or pharmacological agents, Study parameters included incontinence history, physical examination, urinalysis, urine culture, pad weight test, voiding diaries, QOL questionnaires, cystometries and cystoscopies and abdominal Urinary Incontinence Devices and Treatments Oct 15 28

29 leak point pressure measurements. Adverse events reported during the first year of the study included: bacteriuria >100,000 CFU (30%), symptomatic UTI (24%), urinary symptoms (23%), insertion trauma (6%), device performance (5%) and bladder/urethral trauma (3%). As a treatment of moderate to severe stress incontinence, collagen can be injected to artificially inflate the submucosal tissues of the bladder neck, and thus increase urethral resistance to outflow of urine. It is a minimally invasive method and extremely useful for treating women with incontinence who wish to avoid an open surgical procedure. Periurethral bulking agents also are useful for patching up persistent mild stress incontinence after an anti-incontinence operation. Sacral nerve stimulation (SNS) is an implantable, permanent device that modulates the neural pathways controlling bladder function. This is one of several methods used to treat urinary urge incontinence, significant symptoms of urgency-frequency or nonobstructive urinary retention, when other behavioral and/or pharmacologic therapies have failed. Surgery is used to treat the lack of support at the bladder neck when other treatment methods have been ineffective. Surgical procedures include, but are not limited to, sling procedures, augmentation cystoplasty, bladder denervation or detrusor myomectomy, enterocystoplasty, bladder diversion, artificial urinary sphincter and cystectomy. Recently, radiofrequency energy has been investigated as a technique to shrink and stabilize the endopelvic fascia, thus improving the support for the urethra and bladder neck. The minimal published literature regarding transvaginal radiofrequency bladder neck suspension is inadequate to permit scientific conclusions concerning the safety and long-term efficacy of this procedure. Review History for Femsoft Insert Policy September 9, 2003 Medical Advisory Council Review History March 22, 2005 May 2006 September 2006 March 2007 December 2008 February 2009 September 2009 November 2010 September 2011 January 2012 Medical Advisory Council Added Renessa System as investigational treatment of stress urinary incontinence Coding updates Combined Femsoft Medical Policy and Urinary Incontinence Devices and Treatments Policy Added Tibial Nerve Stimulation as investigational treatment of stress urinary incontinence Added coverage for non-implantable pelvic floor electrical stimulator for Medicare members when Medicare criteria met Coding Updates Added FDA approved artificial urinary sphincter devices for males (Eg. AMS 800) medically necessary for the treatment of type III stress urinary incontinence, or intrinsic sphincteric dysfunction Added SURx Transvaginal System as investigational treatment of stress urinary incontinence Update - no revisions. Update - No revisions for commercial members. Medicare table and links to LCD added for Medicare members. Code updates. Update no revisions. Code updates. Update - no revisions Urinary Incontinence Devices and Treatments Oct 15 29

30 October 2012 February 2013 October 2013 October 2014 October 2015 Update Added Renessa System as a treatment of urinary stress incontinence as investigational except for the following scenario: For the transurethral treatment of non-pregnant female stress UI due to hypermobility, only in women who have failed 12 months of conservative treatment and are not candidates for surgical treatment. Added PTNS for moderate to severe urinary dysfunction and overactive bladder symptoms, as medically necessary, up to 12 weeks only. This would be considered medically necessary when specific criteria noted within the policy statement are met. If the member fails to improve after 12 PTNS treatments, continued treatment is considered not medically necessary. Code Updates. Update. Added tension-free vaginal tape (TVT) procedure as medically necessary in females with urodynamically proven stress urinary incontinence who have failed conservative therapy and may have also have failed prior surgical therapy, for primary or recurrent stress urinary incontinence. Update no revisions. Codes updated. Update no revisions. Codes updated. This policy is based on the following evidence-based guidelines: 1. Agency for Healthcare Research and Quality. Overview: Urinary Incontinence in Adults, Clinical Practice Guideline Update The Chartered Society Of Physiotherapy. Clinical guidelines for the physiotherapy management of females aged years with stress urinary incontinence Society of Obstetricians and Gynaecologists of Canada. The Evaluation Of Stress Incontinence Prior To Primary Surgery. April, Scottish Intercollegiate Guidelines Network. Management of Urinary Incontinence in Primary Care. December National Institute for Health and Clinical Excellence. Urinary Incontinence the Management of Urinary incontinence in Women. May Updated March 30, Available at: 6. Hayes Health Technology Brief. Transurethral Radiofrequency Micro-Remodeling Using the Renessa System (Novasys Medical Inc.) for Female Stress Urinary Incontinence. Jan Updated Jan Updated Mar Archived April 19, California Technology Assessment Forum (CTAF). Radiofrequency Microremodeling for the Treatment of Female Stress Urinary Incontinence. Oct. 15, The American College of Obstetricians and Gynecologists. ACOG Pactice Bulletin. Urinary Incontinence in Women. Number 63, June (Reaffirmed 2007) 9. Appell RA, Dmochowski RR, Blaivas J et al. Female Stress Urinary Incontinence Guideline Update Panel. Diagnosis and Treatment Recommendations. In: Guideline for the Surgical Management of Female Stress Urinary Incontinence: 2009 Update. 2009:1-44. American Urological Association (AUA). 10. Karliner L. Radiofrequency micro-remodeling for the treatment of female stress urinary incontinence. A Technology Assessment. California Technology Assessment. October 15, California Technology Assessment Forum (CTAF). Percutaneous Tibial Nerve Stimulation for the Treatment of Overactive Bladder. June 20, Urinary Incontinence Devices and Treatments Oct 15 30

31 12. Hayes. Medical Technology Directory. Tension-Free Vaginal Tape Procedure for Treatment of Female Stress Urinary Incontinence. February 9, Updated April 26, Archived Hayes. Medical Technology Directory. Pelvic Floor Electrical Stimulation for the Treatment of Urinary Incontinence. March 31, Updated March 24, Archived Hayes. Medical Technology Directory. Implantable Sacral Nerve Stimulation for Urinary Voiding Dysfunction. July 12, Updated June 6, Updated May 22, Archived August Hayes. Medical Technology Directory. Extracorporeal Magnetic Stimulation for Urinary Incontinence. May 2, Updated April 29, Updated April 9, Updated Feb 24, Gormley EA, Lightner DJ, Burgio KL, et al. Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU Guideline. American Urologic Association (AUA); Available at: References Update October Dumoulin C, Hay-Smith EJ, Mac Habée-Séguin G. Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women. Cochrane Database Syst Rev 2014; 5:CD Lim R, Lee SW, Tan PY, et al. Efficacy of electromagnetic therapy for urinary incontinence: A systematic review. Neurourol Urodyn Sep 22. doi: /nau [Epub ahead of print]. 3. Lipp A, Shaw C, Glavind K. Mechanical devices for urinary incontinence in women. Cochrane Database Syst Rev. 2014;12:CD Myers DL. Female mixed urinary incontinence: a clinical review. JAMA May;311(19): Qaseem A, Dallas P, Forciea MA, et al. Nonsurgical management of urinary incontinence in women: a clinical practice guideline from the American College of Physicians. Clinical Guidelines Committee of the American College of Physicians. Ann Intern Med Sep;161(6): Tsai PY, Wang CP, Hsieh CY, et al. Arch Phys Med Rehabil Dec;95(12): doi: /j.apmr Epub 2014 Jul Yaminishi T, Homma Y, Nishizawa O, et al. Multicenter, randomized, shamcontrolled study on the efficacy of magnetic stimulation for women with urgency urinary incontinence. Int J Urol Apr;21(4): doi: /iju Epub 2013 Oct 14. References Update October Carr LK, Robert M, Kultgen PL, et al. Autologous muscle derived cell therapy for stress urinary incontinence: A prospective, dose ranging study. J Urol. 2013;189(2): Paik SH, Han SR, Kwon OJ, et al. Acupuncture for the treatment of urinary incontinence: A review of randomized controlled trials. Exp Ther Med. 2013;6(3): Peters KM, Carrico DJ, Wooldridge LS, et al. Percutaneous tibial nerve stimulation for the long-term treatment of overactive bladder: 3-year results of the STEP study. J Urol. 2013;189(6): Phe V, Nguyen K, Roupret M, et al. A systematic review of the treatment for female stress urinary incontinence by ACT balloon placement (Uromedica, Irvine, CA, USA). World J Urol Jun 20. [Epub ahead of print), Urinary Incontinence Devices and Treatments Oct 15 31

32 References Update October Monga AK, Tracey MR, Subbaroyan J. A systematic review of clinical studies of electrical stimulation for treatment of lower urinary tract dysfunction. Int Urogynecol J Aug;23(8): doi: /s Epub 2012 Mar Nager CW, Tan-Kim J. Stress urinary incontinence in women: Retropubic midurethral slings. UpToDate. February 4, Zhu VP et al. Pelvic floor electrical stimulation for postprostatectomy urinary incontinence: a meta-analysis. Urology, Vol 79, Iss 3 (March 2012). References Update October Clinicaltrials.gov. Renessa Objective and Subjective Efficacy Study (ROSE). ClinicalTrials.gov Identifier NCT January Available at: 2. Davilla GW. Nonsurgical Outpatient Therapies for the Management of Female Stress Urinary Incontinence: Long-Term Effectiveness and Durability. Adv Urol. 2011; 2011: DuBeau C. Treatment of urinary incontinence. UpToDate. July 6, Elser DM, Mitchell Gk, Miklos JR, et al. Nonsurgical Transurethral Radiofrequency Collagen Denaturation: Results at Three Years after Treatment. Advances in Urology. Volume 2011,(2011), Article ID , 9 pages. 5. Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). 510(k) Premarket Notification Database. K Novasys Transurethral RF System. July 22, Available at: 6. Jelovsik JE, Reddy J, Stress urinary incontinence in women: Preoperative evaluation for a primary procedure. UpToDate. June 6, Lukban JC. Transurethral Radiofrequency Collagen Denaturation for Treatment of Female Stress Urinary Incontinence: A Review of the Literature and Clinical Recommendations. Obstet Gynecol Int. 2012; 2012: Nager C. Trial of Maintenance Therapy with Posterior Tibial Nerve Stimulation for Overactive Bladder Available at: 9. Peters KM, Carrico DJ, Perez-Marrero RA, et al. Randomized Trial of Percutaneous Tibial Nerve Stimulation Versus Sham Efficacy in the Treatment of Overactive Bladder Syndrome: Results From the SUmiT Trial. The Journal of Urology. 2010;183 (4): Peters KM, Carrico DJ, Macdiarmid SA, et al. Sustained therapeutic effects of percutaneous tibial nerve stimulation: 24-month results of the STEP study. Neurourol Urodyn. Jun Ranessa System. Novasys Medical Available at: Zanetti MR, Castro Rde A, Rotta AL, et al. Impact of supervised physiotherapeutic pelvic floor exercises for treating female stress urinary incontinence. Sao Paulo Med J Sep 6; 125(5): References Update January Dumoulin C, Hay-Smith J. Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women. Cochrane Database Syst Rev Jan 20;(1):CD Goode PS, Burgio KL, Johnson TM, 2nd, et al. Behavioral therapy with or without biofeedback and pelvic floor electrical stimulation for persistent Urinary Incontinence Devices and Treatments Oct 15 32

33 postprostatectomy incontinence: a randomized controlled trial. JAMA Jan 12;305(2): Yamanishi T, Mizuno T, Watanabe M, et al. Randomized, placebo controlled study of electrical stimulation with pelvic floor muscle training for severe urinary incontinence after radical prostatectomy. J Urol Nov;184(5): References Update September de Sèze M, Raibaut P, Gallien P, et al. Transcutaneous posterior tibial nerve stimulation for treatment of the overactive bladder syndrome in multiple sclerosis: results of a multicenter prospective study. Neurourol Urodyn Mar;30(3): Eyjólfsdóttir H, Ragnarsdóttir M, Geirsson G. Pelvic floor muscle training with and without functional electrical stimulation as treatment for stress urinary incontinence. Laeknabladid Sep;95(9):575-80; 3. Finazzi-Agrò E, Petta F, Sciobica F, et al. Percutaneous tibial nerve stimulation effects on detrusor overactivity incontinence are not due to a placebo effect: a randomized, double-blind, placebo controlled trial. J Urol Nov;184(5): Gameiro MO, Moreira EH, Gameiro FO et al. Vaginal weight cone versus assisted pelvic floor muscle training in the treatment of female urinary incontinence. A prospective, single-blind, randomized trial. Int Urogynecol J Pelvic Floor Dysfunct Apr;21(4): Gobbi C, Digesu G, Khullar V, et al. Percutaneous posterior tibial nerve stimulation as an effective treatment of refractory lower urinary tract symptoms in patients with multiple sclerosis: preliminary data from a multicentre, prospective, open label trial. Mult Scler Jul Peters KM, Carrico DJ, Perez-Marrero RA,et al. Randomized trial of percutaneous tibial nerve stimulation versus Sham efficacy in the treatment of overactive bladder syndrome: results from the SUmiT trial. J Urol Apr;183(4): Santos PF, Oliveira E, Zanetti MR, et al. Electrical stimulation of the pelvic floor versus vaginal cone therapy for the treatment of stress urinary incontinence. Rev Bras Ginecol Obstet Sep;31(9): Schreiner L, dos Santos TG, Knorst MR, da Silva Filho IG. Randomized trial of transcutaneous tibial nerve stimulation to treat urge urinary incontinence in older women. Int Urogynecol J Pelvic Floor Dysfunct Sep;21(9): References Update November Carpenter DA, Visovsky C. Stress urinary incontinence: a review of treatment options. AORN J Apr;91(4):471-8; quiz Dillon B, Dmochowski R. Radiofrequency for the treatment of stress urinary incontinence in women. Curr Urol Rep Sep;10(5): References Update September Atala A. Regenerative Medicine and Tissue Engineering in Urology. Urologic Clinics of North America. Volume 36, Issue 2 (May 2009). References Update February Elser DM, Mitchell GK, Miklos JR et al. Nonsurgical transurethral collagen denaturation for stress urinary incontinence in women: 12-month results from a prospective long-term study. J Minim Invasive Gynecol Jan-Feb; 16(1): Urinary Incontinence Devices and Treatments Oct 15 33

34 2. Appell RA. Transurethral collagen denaturation for women with stress urinary incontinence. Curr Urol Rep Sep; 9(5): Ismail SI. Radiofrequency remodelling of the endopelvic fascia is not an effective procedure for urodynamic stress incontinence in women. Int Urogynecol J Pelvic Floor Dysfunct Sep; 19(9): Appell RA, Singh G, Klimberg IW, et al. Nonsurgical, radiofrequency collagen denaturation for stress urinary incontinence: retrospective 3-year evaluation. Expert Rev Med Devices Jul; 4(4): Buchsbaum GM, McConville J, Korni R, Duecy EE. Outcome of transvaginal radiofrequency for treatment of women with stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct Mar; 18(3): Vianello A, Costantini E, Del Zingaro M, Porena M. Mini-invasive techniques for the treatment of female stress urinary incontinence. Minerva Ginecol Dec; 59(6): Wells WG, Lenihan JP Jr. Use of in-office anesthesia during non-surgical radiofrequency collagen denaturation for stress urinary incontinence. Curr Med Res Opin Jun; 23(6): Appell RA, Juma S, Wells WG, Lenihan JP et al, Transurethral radiofrequency energy collagen micro-remodeling for the treatment of female stress urinary incontinence. Neurourol Urodyn. 2006; 25(4): Lenihan JP. Comparison of the quality of life after nonsurgical radiofrequency energy tissue micro-remodeling in premenopausal and postmenopausal women with moderate-to-severe stress urinary incontinence. Am J Obstet Gynecol Jun; 192(6): Lenihan JP, Palacios P, Sotomayor M. et al. Oral and local anesthesia in the nonsurgical radiofrequency-energy treatment of stress urinary incontinence. J Minim Invasive Gynecol Sep-Oct; 12(5): Ross JW, Galen DI, Abbott K, et al. A prospective multisite study of radiofrequency bipolar energy for treatment of genuine stress incontinence. J Am Assoc Gynecol Laparosc Nov; 9(4): Novasys Medical. Renessa. Available at: References Update December Staskin DR, Comiter CV. Wein: Campbell-Walsh Urology, 9th Edition. Chapter 74, Surgical Treatment of Male Sphincteric Urinary Incontinence: The Male Perineal Sling and Artifiical Urinary Sphincter. Prosthetics for Male Incontinence. 2. Ramsay AK, Granitsiotis P, Conn IG. The use of the artificial urinary sphincter in the West of Scotland: a single centre 10-year experience. Scott Med J May; 52(2): O'Connor RC, Nanigian DK, Patel BN, et al. Artificial urinary sphincter placement in elderly men. Urology Jan; 69(1): Sajad KP. Artificial Urinary Sphincter. emedicine. June 13, Available at: 5. Corcos J, Gajewski J, Heritz D, et al. Canadian Urological Association guidelines on urinary incontinence. Can J Urol Jun; 13(3): Wilson SK, Delk JR 2nd. Ectopic placement of AMS 800 urinary control system pressure-regulating balloon. Urology. Jan 2005; 65(1): Patki P, Hamid R, Shah PJ. Long-term efficacy of AMS 800 artificial urinary sphincter in male patients with urodynamic stress incontinence due to spinal cord lesion. Spinal Cord May; 44(5): Urinary Incontinence Devices and Treatments Oct 15 34

35 8. Simon P, Zerbib M, Debré B, et al. Results of the AMS 800 artificial urinary sphincter in men, based on a series of 47 patients. 1: Prog Urol Apr; 15(2): Pichon Riviere A, Augustovski F, Cernadas C, et al. AMS 800 artificial urinary sphincter for children with urinary incontinence [summary]. Report IRR No. 3. Buenos Aires, Argentina: Institute for Clinical Effectiveness and Health Policy (IECS); U.S. Food and Drug Administration (FDA). Summary of Safety and Effectiveness of Sphincter AMS 800. References Update September Amaro JL, Gameiro MO, Kawano PR, et al. Intravaginal electrical stimulation: a randomized, double-blind study on the treatment of mixed urinary incontinence. Acta Obstet Gynecol Scand. 2006;85(5): Berghmans B. The role of the pelvic physical therapist. Actas Urol Esp Feb;30(2): Bosch JL. Electrical neuromodulatory therapy in female voiding dysfunction. BJU Int Sep;98 Suppl 1:43-8. Centers for Medicare and Medicaid Services. National Coverage Decision for Non- Implantable Pelvic Floor Electrical Stimulator. 4. Cystomedix. Urgent PC Neuromodulation System for Percutaneous Tibial Nerve Stimulation. 5. Neumann PB, Grimmer KA, Deenadayalan Y. Pelvic floor muscle training and adjunctive therapies for the treatment of stress urinary incontinence in women: a systematic review. BMC Womens Health Jun 28;6(1):11 6. van Balken MR, Verguns H, Bemelmans BL. Sexual functioning in patients with lower urinary tract dysfunction improves after percutaneous tibial nerve stimulation. Int J Impot Res Mar 9; 7. van Balken MR, Vergunst H, Bemelmans BL. Prognostic factors for successful percutaneous tibial nerve stimulation. Eur Urol Feb;49(2): Van der Pal F, van Balken MR, Heesakkers JP, et al. Percutaneous tibial nerve stimulation in the treatment of refractory overactive bladder syndrome: is maintenance treatment necessary? BJU Int Mar;97(3): Van der Pal F, van Balken MR, Heesakkers JP, et al. Correlation between quality of life and voiding variables in patients treated with percutaneous tibial nerve stimulation. BJU Int Jan;97(1): Cooperberg MR, Stoller ML. Percutaneous neuromodulation. Urol Clin North Am Feb;32(1):71-8, vii 11. Finazzi Agro E, Campagna A, Sciobica F, et al. Posterior tibial nerve stimulation: is the once-a-week protocol the best option? Minerva Urol Nefrol Jun;57(2): De Gennaro M, Capitanucci ML, Mastracci P, et al. Percutaneous tibial nerve neuromodulation is well tolerated in children and effective for treating refractory vesical dysfunction. J Urol May;171(5): Karademir K, Baykal K, Sen B, et al. A peripheric neuromodulation technique for curing detrusor overactivity: Stoller afferent neurostimulation. Scand J Urol Nephrol. 2005;39(3): Pannek J, Nehiba M. Initial results of Stoller peripheral neuromodulation in disorders of bladder function. Urologe A Nov;42(11): van Balken M.R., Vandoninck V., Messelink B.J., Percutaneous tibial nerve stimulation as neuromodulative treatment of chronic pelvic pain. Eur Urol (2003) 43 : pp Urinary Incontinence Devices and Treatments Oct 15 35

36 16. Vandoninck V, Van Balken MR, Finazzi Agro E, et al. Posterior tibial nerve treatment of urge incontinence. Neurourol Urodyn. 2003;22(1): Krivoborodov GG, Mazo EB, Shvarts PG. Afferent stimulation of the tibial nerve in patients with hyperactive bladder. Urologiia Sep-Oct;(5): Govier FE, Litwiller S, Nitti V, et al. Percutaneous afferent neuromodulation for the refractory overactive bladder: results of a multicenter study. J Urol Apr;165(4): van Balken M.R., Vandoninck V., Gisolf K.W., Posterior tibial nerve stimulation as neuromodulative treatment of lower urinary tract dysfunction. J Urol (2001) 166 : pp References Update May Lenihan JP. Comparison of the quality of life after nonsurgical radiofrequency energy tissue micro-remodeling in premenopausal and postmenopausal women with moderate-to-severe stress urinary incontinence. Am J Obstet Gynecol Jun;192(6): Sotomayor M, Bernal GF. Twelve-month results of nonsurgical radiofrequency energy micro-remodeling for stress incontinence. Int Urogynecol J Pelvic Floor Dysfunct May-Jun;16(3): Sotomayor M, Bernal GF. Transurethral delivery of radiofrequency energy for tissue micro-remodeling in the treatment of stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct Dec;14(6): References for Femsoft Insert Initial 1. Rochester Medical Corporation (website) Femsoft Insert. Updated July 2003 Accessed August 4, Sirls, LT, Foot JE, Kaufmanns, JM et al. Long-term results of the Femsoft urethral insert for the management of female stress urinary incontinence Int Urogynecol J Pelvic Floor Dysfunct. 2002;13(2):88-95 U.S. Food and Drug Administration. Femsoft insert. 3. Centers of Medicare and Medicaid Services (CMS) DMERC. 4. Versi E, Griffiths DJ, Harvey MA. A new external urethral occlusive device for female urinary incontinence. Obstet Gynecol. 1998;92(2): Staskin D, Bavendam T, Miller J, et al. Effectiveness of a urinary control insert in the management of stress urinary incontinence: early results of a multicenter study. Urology. 1996;47(5): Moore KH, Simons A, Dowell C, et al. Efficacy and user acceptability of the urethral occlusive device in women with urinary incontinence. J Urol. 1999b;162(2): References for Urinary Incontinence Devices and Treatments - Initial 1. Wein AJ. Pharmacotherapy for stress urinary incontinence. Present and future options. J Urol Mar;173(3): American Academy of Familiy Physicians. Information from your family doctor. Pelvic floor muscle exercises. Am Fam Physician Jan 15;71(2): Weiss BD. Selecting medications for the treatment of urinary incontinence. Am Fam Physician Jan 15;71(2): Andersson KE, Wein AJ. Pharmacology of the lower urinary tract: basis for current and future treatments of urinary incontinence. Pharmacol Rev Dec;56(4): Urinary Incontinence Devices and Treatments Oct 15 36

37 5. Dmochowski RR, Avon M, Ross J et al. Transvaginal radio frequency treatment of the endopelvic facsia: a prospective evaluation for the treatment of genuine stress urinary incontinence. J Urol 2003;169(3): Aksac B, Aki S, Karan A et al. Biofeedback and pelvic floor exercises for the rehabilitation of urinary stress incontinence. Gynecol Obstet Invest 2003;56: Wille S, Sobottka A, Heidenreich A, Hofmann R. Pelvic floor exercises, electrical stimulation and biofeedback after radical prostatectomy: results of a prospective randomized trial. J Urol 2003;170: Parekh AR, Feng MI, Kirages D et al. The role of pelvic floor exercises on postprostatectomy incontinence. J Urol 2003;170: Ross JW, Galen DI, Abbott K et al. A prospective multisite study of radiofrequency bipolar energy for treatment of genuine stress incontinence. J Am Assoc Gynecol Laparosc 2002;9(4): Floratos DL, Sonke GS, Rapidou CA et al. Biofeedback vs. verbal feedback as learning tools for pelvic muscle exercises in the early management of urinary incontinence after radical prostatectomy. BJU Int 2002;89(7): Hay-Smith EJC, Bo K, Berghamans LCM et al. Pelvic floor muscle training for urinary incontinence in women (Cochrane Review). In: The Cochrane Library, Issue 3, Morkved S, Bo K, Fjortoft T. Effect of adding biofeedback to pelvic floor muscle training to treat urodynamic stress incontinence. Obstet Gynecol Oct;100(4): Burgio KL, Goode PS, Locher JL, et al. Behavioral training with and without biofeedback in the treatment of urge incontinence in older women: a randomized controlled trial. JAMA Nov 13;288(18): Sirls, LT, Foot JE, Kaufmanns, JM et al. Long-term results of the Femsoft urethral insert for the management of female stress urinary incontinence Int Urogynecol J Pelvic Floor Dysfunct. 2002;13(2): Pages IH, Jahr S, Schaufele MK et al. Comparative analysis of biofeedback and physical therapy for treatment of urinary stress incontinence in women. Am J Phys Med Rehabil 2001;80(7): Bales GT, Gerber GS, Minor TX et al. Effect of preoperative biofeedback/pelvic floor training on continence in men undergoing radical prostatectomy. Urology 2000;56(4): Franke JJ, Gilbert WB, Grier J et al. Early post-prostatectomy pelvic floor biofeedback. J Urol 2000;163(1): Van Kampen M, De Weerdt W, Van Poppel H et al. Effect of pelvic-floor reeducation on duration and degree of incontinence after radical prostatectomy: a randomised controlled trial. Lancet 2000;355(9198): Burgio KL, Locher JL, Goode PS. Combined behavioral and drug therapy for urge incontinence in older women. J Am Geriatr Soc 2000;48(4): Jeyaseelan SM,Haslam EJ,Winstanly J et al. An evaluation of a new pattern of electrical stimulation as a treatment for urinary stress incontinence: a randomized,double-blind, controlled trial. Clin Rehabil 2000;14(6): Yamanishi,T, Yasuda K, Sakakibara R et al. Randomized,double-blind study of electrical stimulation for urinary incontinence due to detrusor overactivity. Urology 2000;55(3): McDougall EM, Heidorn CA, Portis AJ et al. Laparoscopic bladder neck suspension fails the test of time. J Urol 1999;162(6): McDowell BJ, Engberg S, Sereika S et al. Effectiveness of behavioral therapy to treat incontinence in homebound older adults. J Am Geriatr Soc 1999;47(3): Urinary Incontinence Devices and Treatments Oct 15 37

38 24. Weatherall M. Biofeedback or pelvic floor muscle exercises for female genuine stress incontinence and sexual function after anatomic radical prostatectomy: a meta-analysis of trials identified in a systematic review. BJU Int 1999;83(9): Galloway. N, El-Galley R, Appell R et al. Extracorporeal Magnetic Innervation Therapy for Stress Urinary Incontinence. Urology 1999;53: Schmidt RA, et al. Sacral nerve stimulation for the treatment of refractory urinary urge incontinence. J Urol. 1999;162(2); Burgio KL, Locher JL, Goode PS et al. Behavioral vs. drug treatment for urge urinary incontinence in older women: a randomized controlled trial. JAMA 1998;280(23): Berghmans LC, Hendriks HJ, Bo K et al. Conservative treatment of stress urinary incontinence in women: a systematic review of randomized clinical trials. Br J Urol 1998;82(2): Versi E, Griffiths DJ, Harvey MA. A new external urethral occlusive device for female urinary incontinence. Obstet Gynecol. 1998;92(2): Shaker HS, Hassouna M. Sacral nerve root neuromodulation: An effective treatment for refractory urge incontinence. J Urol. 1998;159: Bo K, Talseth T. Change in Urethral Pressure During Voluntary Pelvic Floor Muscle Contraction and Vaginal Electrical Stimulation. International Urogynecology Journal and Pelvic floor dysfunction 1997; 8: Choe JM, Staskin DDR, Clinical usefulness of urinary control urethral insert devices International Urogynecology Journal and Pelvic floor dysfunction 1997; 8: Gallo ML, Hancock R, Davila W. Clinical experience with a balloon-tipped urethral insert for stress urinary incontinence. Journal of Wound, Ostomy and Continence Nurses Society 1997:24: Janknegt RA, et al. Improving neuromodulation techniques for refractory voiding dysfunctions: Two-stage implant. Urology. 1997;49: Staskin D, Bavendam T, Miller J, et al. Effectiveness of a urinary control insert in the management of stress urinary incontinence: early results of a multicenter study. Urology. 1996;47(5): Bosch J, Groen J. Sacral (S3) segmental nerve stimulation as a treatment for urge incontinence in patients with detrusor instability: Results of chronic electrical stimulation using an implantable neural prosthesis. J Urol. 1995;154: Important Notice General Purpose. Health Net's National Medical Policies (the "Policies") are developed to assist Health Net in administering plan benefits and determining whether a particular procedure, drug, service or supply is medically necessary. The Policies are based upon a review of the available clinical information including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the drug or device, evidence-based guidelines of governmental bodies, and evidence-based guidelines and positions of select national health professional organizations. Coverage determinations are made on a case-by-case basis and are subject to all of the terms, conditions, limitations, and exclusions of the member's contract, including medical necessity requirements. Health Net may use the Policies to determine whether under the facts and circumstances of a particular case, the proposed procedure, drug, service or supply is medically necessary. The conclusion that a procedure, drug, service or supply is medically necessary does not constitute coverage. The member's contract defines which procedure, drug, service or supply is covered, excluded, limited, or subject to dollar caps. The policy provides for clearly written, reasonable and current criteria that have been approved by Health Net s National Medical Advisory Council (MAC). The clinical criteria and medical policies provide guidelines for determining the medical necessity criteria for specific procedures, equipment, and services. In order to be eligible, all services must be medically necessary and otherwise defined in the member's benefits contract as described this "Important Notice" disclaimer. In all cases, final benefit determinations are based on the applicable contract language. To the extent there are any conflicts between medical policy guidelines and applicable contract language, the contract language Urinary Incontinence Devices and Treatments Oct 15 38

39 prevails. Medical policy is not intended to override the policy that defines the member s benefits, nor is it intended to dictate to providers how to practice medicine. Policy Effective Date and Defined Terms. The date of posting is not the effective date of the Policy. The Policy is effective as of the date determined by Health Net. All policies are subject to applicable legal and regulatory mandates and requirements for prior notification. If there is a discrepancy between the policy effective date and legal mandates and regulatory requirements, the requirements of law and regulation shall govern. * In some states, prior notice or posting on the website is required before a policy is deemed effective. For information regarding the effective dates of Policies, contact your provider representative. The Policies do not include definitions. All terms are defined by Health Net. For information regarding the definitions of terms used in the Policies, contact your provider representative. Policy Amendment without Notice. Health Net reserves the right to amend the Policies without notice to providers or Members. In some states, prior notice or website posting is required before an amendment is deemed effective. No Medical Advice. The Policies do not constitute medical advice. Health Net does not provide or recommend treatment to members. Members should consult with their treating physician in connection with diagnosis and treatment decisions. No Authorization or Guarantee of Coverage. The Policies do not constitute authorization or guarantee of coverage of particular procedure, drug, service or supply. Members and providers should refer to the Member contract to determine if exclusions, limitations, and dollar caps apply to a particular procedure, drug, service or supply. Policy Limitation: Member s Contract Controls Coverage Determinations. Statutory Notice to Members: The materials provided to you are guidelines used by this plan to authorize, modify, or deny care for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract. The determination of coverage for a particular procedure, drug, service or supply is not based upon the Policies, but rather is subject to the facts of the individual clinical case, terms and conditions of the member s contract, and requirements of applicable laws and regulations. The contract language contains specific terms and conditions, including pre-existing conditions, limitations, exclusions, benefit maximums, eligibility, and other relevant terms and conditions of coverage. In the event the Member s contract (also known as the benefit contract, coverage document, or evidence of coverage) conflicts with the Policies, the Member s contract shall govern. The Policies do not replace or amend the Member s contract. Policy Limitation: Legal and Regulatory Mandates and Requirements The determinations of coverage for a particular procedure, drug, service or supply is subject to applicable legal and regulatory mandates and requirements. If there is a discrepancy between the Policies and legal mandates and regulatory requirements, the requirements of law and regulation shall govern. Reconstructive Surgery CA Health and Safety Code requires health care service plans to cover reconstructive surgery. Reconstructive surgery means surgery performed to correct or repair abnormal structures of the body caused by congenital defects, developmental abnormalities, trauma, infection, tumors, or disease to do either of the following: (1) To improve function or (2) To create a normal appearance, to the extent possible. Reconstructive surgery does not mean cosmetic surgery," which is surgery performed to alter or reshape normal structures of the body in order to improve appearance. Requests for reconstructive surgery may be denied, if the proposed procedure offers only a minimal improvement in the appearance of the enrollee, in accordance with the standard of care as practiced by physicians specializing in reconstructive surgery. Reconstructive Surgery after Mastectomy California Health and Safety Code requires treatment for breast cancer to cover prosthetic devices or reconstructive surgery to restore and achieve symmetry for the patient incident to a mastectomy. Urinary Incontinence Devices and Treatments Oct 15 39

40 Coverage for prosthetic devices and reconstructive surgery shall be subject to the co-payment, or deductible and coinsurance conditions, that are applicable to the mastectomy and all other terms and conditions applicable to other benefits. "Mastectomy" means the removal of all or part of the breast for medically necessary reasons, as determined by a licensed physician and surgeon. Policy Limitations: Medicare and Medicaid Policies specifically developed to assist Health Net in administering Medicare or Medicaid plan benefits and determining coverage for a particular procedure, drug, service or supply for Medicare or Medicaid members shall not be construed to apply to any other Health Net plans and members. The Policies shall not be interpreted to limit the benefits afforded Medicare and Medicaid members by law and regulation. Urinary Incontinence Devices and Treatments Oct 15 40