InterStim CONSULTATION INFORMATION. Round Rock: North Austin: Westlake:

Transcription

1 InterStim CONSULTATION INFORMATION Round Rock: North Austin: Westlake:

2 TABLE OF CONTENTS Section 1: Providers Dr. Melody Denson.p. 1 Dr. Bryan Kansas...p. 1 Danielle Manes, PA-C p. 1 Section 2: Making An Informed Decision The Urinary System...p. 2 Sacral Nerve Stimulation pp. 3-4 Clinical Study Results / Problems or Complications.p. 3 Permanent Placement.p. 4 Who are Candidates?...p. 5 Limitations / Bladder Control..p. 5 Section 3: Surgery and Aftercare Predetermination For InterStim Placement...p. 6 Urology Team Billing.p. 6 Pre-op Instructions...p. 7 Post-op Hospital Visit..p. 7 After Your Surgery / MRI Protocol. p. 8 Stage 4: Troubleshooting Answers to Common Questions.p. 9 Contact Information and Times..p. 9

3 Section 1: Providers Dr. Melody Denson Dr. Melody Denson joined The Urology Team in September She earned her medical degree at the University of Nebraska and was a resident urologist at the University of Iowa Hospital and clinics. She was as a urologic surgeon at the Naval Medical Center in Portsmouth, and the Trinity Clinic Urologic Institute & Continence Center in Tyler, Texas. Dr. Denson's areas of specialty are Pelvic Organ Prolapse, chronic pelvic pain, Urinary Incontinence, Interstim Sacral Nerve Placement and Vasectomy. Dr. Denson is ranked in the top ten InterStim implanters in the United States for 2010 as ranked by Medtronic manufacturer of the InterStim device. Dr. Bryan Kansas Dr. Bryan Kansas, M.D. joined the staff of The Urology Team in August Dr. Kansas graduated from Louisiana State University Medical School in Shreveport, LA, and completed his general surgery and urology training at Temple University Hospital in Philadelphia, PA. Dr. Kansas has vast experience in the treatment of complex kidney stone disease, the treatment of benign and malignant renal tumors, the diagnosis and treatment of bladder cancer, and specializes in the placement of penile prostheses for erectile dysfunction. Dr. Kansas is also certified in placement of the InterStim sacral nerve stimulator device for refractory overactive bladder. Danielle Manes, PA-C Danielle Manes, PA-C joined The Urology Team in 2012 after having practiced family and internal medicine in both South Texas and New Orleans. Originally from Baton Rouge, Danielle earned her Master of Science in Medicine from the Physician Assistant program at Trevecca Nazarene University, Nashville, TN. She also earned a Masters in Biological Sciences from the Louisiana State University. Her research experience includes working with NASA researching extreme bacterial diversity found in the Atacama Desert in Chile. While women's urological health is her primary focus at The Urology Team, she does work with both male and female patients. Her areas of expertise include chronic pelvic pain or Interstitial Cystitis, Incontinence, InterStim reprogramming, kidney stones, and recurrent bladder infections. Danielle s role at the Urology Team has been expanded to oversee our InterStim program. 1

4 Section 2: Making An Informed Decision The Urinary System How Does The Urinary System Work? To understand how sacral nerve stimulation works, it is helpful to understand how the urinary system works. The urinary system includes two kidneys, two ureters, the bladder and the urethra (see Figure 1). The kidneys remove excess fluid and waste products from the blood and continuously produce urine. The ureters carry the urine to the bladder where the urine is stored. A muscle called a sphincter controls the opening and closing of the urethra (urine flows through the urethra during urination). Pubic Bone Womb Bowel Pelvic Floor Muscles Urine Pelvis Urethra Pelvic Floor Muscles Figure 1. Anatomy of the Bladder Control System Bladder Muscle Sphincter Muscles When the bladder begins to fill with urine, a message is sent along the sacral nerves to the brain telling the brain that the bladder is getting full (see Figure 2). As the bladder fills, this message to the brain becomes stronger. When the message becomes strong enough, and you decide to urinate, your brain sends a message back to the bladder along the sacral nerves telling the bladder muscle to contract and the pelvic muscles to relax to allow Brain urine to empty from the bladder (urination). Urination is usually under voluntary control. This means that you decide when and where you want to urinate. Central Nervous System (brain and spinal cord) Bladder Spinal Cord Nerve signals to bladder and sphincter muscles Why Do Some People Have Bladder Control Problems? Sometimes, the two-way communication between the brain and bladder is disrupted. When this happens, patients may experience symptoms of bladder control problems. For many patients, sacral nerve stimulation may augment the communication between the brain and the bladder therefore reducing the symptoms associated with bladder control problems. Urethra Sphincter Muscles Figure 2. Communication Between the Brain and the Bladder 2

5 Sacral Nerve Stimulation (SNS) What is Sacral Nerve Stimulation Therapy? You may be one of millions of people who suffer from frustrating and embarrassing bladder control problems such as retention and overactive bladder. Effects of bladder control problems can be devastating. These conditions prevent you from controlling when and how much you urinate and can make simple everyday activities a challenge and social lives very difficult. You may have to cut back on your hobbies or stop working. You may feel trapped by a fear of leaking accidents, the need to be close to a bathroom at all times, and an overall, preoccupation with your bladder. You can be any age to have bladder control problems. You have probably found that treatments such as drugs, behavior modification, diet changes, pelvic floor exercises or the use of a catheter to empty your bladder did not effectively treat your symptoms. In the past there were few options for patients who did not respond to these therapies. Now, however, your doctor would like you to consider a therapy called sacral nerve stimulation (SNS). SNS involves the use of a device that can be thought of as a pacemaker for the bladder. SNS therapy is not experimental. InterStim Therapy (InterStim is a registered trademark of Medtronic, Inc.), is a sacral nerve stimulation therapy made by Medtronic. It was approved by the U.S. Food and Drug Administration (FDA) in 1997 and has been used successfully to treat thousands of patients worldwide. InterStim therapy is indicated for people with urinary retention and the symptoms of overactive bladder including urinary urge incontinence and significant symptoms of urgency, frequency in selected individuals.* At the heart of this therapy is an innovative and implantable neurostimulator about the size of a stop watch. The therapy uses a small implanted medical device to send mild electrical pulses to a nerve located just above the tail bone. These nerves are called sacral nerves. The sacral nerves [specifically S2, S3 and S4] activate or inhibited muscles and organs that contribute to urinary control-the bladder, sphincter and pelvic floor muscles. The electrical stimulation may eliminate or reduce certain bladder control functions in some people. This stimulation may facilitate the communication between the brain and bladder, and may relieve the symptoms of urinary retention or symptoms of overactive bladder, including urinary urge incontinence and significant symptoms of urgency-frequency in some patients. InterStim therapy does not treat symptoms of stress incontinence. It has not been studied in pregnant patients, pediatric patients, patients with diabetes, or patients with multiple sclerosis. It is not intended for patients with mechanical obstruction such as benign prostatic hypertrophy, cancer or urethral strictures. Clinical Study Results Medtronic conducted an international, multi-center clinical study using Medtronic InterStim Therapy. Patients included in the study had symptoms of urge incontinence, urgency-frequency or retention. The study showed that the InterStim Therapy successfully treated the symptoms of urge incontinence, urgency-frequency or retention. The results of the study are summarized in Figure 7. Results from Multicenter Clinical Study* After Twelve Months of InterStim Therapy Urge Incontinence: (n=38) Urgency - Frequency: (n=33) Retention: (n=38) *The multi-center study included 23 centers worldwide. A total of 581 patients were studied with 219 of them receiving InterStim Therapy. **In patients with a baseline degree of >7 voids per day. ***Success is defined as increased voided volume with the same or reduced degree of urgency. Clinical Success Clinical Success Clinical Success Clinical Success Clinical Success Figure 7. Clinical Study Results 3

6 How is the Test for SNS Therapy Done? Placing the Test Stimulation Lead SNS therapy is delivered in two procedures. The first is the test to see if the therapy will work for you. A test [temporarily test stimulation] is used before implantation of the InterStim Neurostimulator to see what the effect of the stimulation is on your symptom. If this test is positive the lead will stay in place and you will proceed to the permanent implant. There are two types of leads used for test stimulation, a temporary lead or a long-term lead. Your doctor will explain the test stimulation procedure you will be undergoing. The test stimulation lead is inserted in the doctor's office, surgical center, or hospital, depending upon the type of lead placed and your physician's preference. Your doctor will explain the type of anesthesia that will be used for your procedure. The medical team will make you as comfortable as possible during the procedure. You may be given pain medication and a sedative that will make your feel relaxed and drowsy, but able to cooperate during the procedure. Or, you may be given general anesthesia. While you are lying on your stomach, your doctor will insert a lead and position it near a sacral nerve. The sacral nerves are located near the tailbone. During the procedure you may be asked to describe what you feel when the sacral nerve is stimulated. You may feel a "pulling", "tingling" or "tapping" sensation in your pelvic muscles and movement of your big toe. Women may feel a sensation in the vaginal area and men in the scrotum. Most likely you will go home the same day the lead is placed. If a temporary lead was used, it will exit your skin in your lower back. It will be taped to your skin and attached to the external test stimulator that you wear when you go home (see Figure 3). If a long-term lead is used, a small wire is attached to the lead. The wire exits a small incision in your lower back or upper buttock. This wire is connected to the external test stimulator that you wear when you go home (see Figure 4). Temporary Lead Lead (External) Rubber Ground Pad Connector Test Stimulator Medtronic, Inc. Used by permission Figure 3. Test Stimulation Using the Temporary Lead Exit Site Cable Test Stimulator Medtronic, Inc. Used by permission Figure 4. Test Stimulation Using the Long-term Lead Permanent Placement Implanting the SNS Device The implant procedure is performed in an operating room. As with the test stimulation procedure, the medical team will make you as comfortable as possible during the procedure. Your doctor will discuss the type of anesthesia to be used. You will either be given pain medication and a sedative or general anesthesia. You will have one or two incisions. The incision made for the neurostimulator will be about 2 inches long; the other incision will be small, about ½ inch or less. The entire system will be under your skin. If a temporary lead was used for the test stimulation: Long-term Lead Neurostimulator Medtronic, Inc. Used by permission the lead will be removed Figure 5. Implant of Lead and Neurostimulator (battery a long-term lead and neurostimulator will be implanted in the upper buttock or abdomen and electronics) If a long-term lead was used for the test stimulation (see Figure 5): the long-term lead will remain in place the external wire used for test stimulation will be removed, and a neurostimulator will be connected to the long-term lead and placed under the skin in the upper buttock or abddomen. 4

7 Problems or Complications As with any surgical procedure, problems can occur. These problems may be resolved with reprogramming of the system, medications or surgery. The InterStim System can always be removed, if necessary. The following events and approximate rate of occurrence occurred during the InterStim Therapy clinical study: pain where the neurostimulator is placed (15%), new pain (9%), movement of the lead (8%), infection (6%), sudden and brief increase in stimulation - sometimes described as shocking or jolting - (6%), pain at lead site (5%), significant change in bowel function (3%). The following problems each occurred less than 2% of the time: technical problems, suspected device problem, change in menstrual cycle, adverse change in voiding function, persistent skin irritation, suspected nerve injury, and device rejection. The following problems each occurred less than 0.5% of the time: change in sensation of stimulation, grand mal seizure, hematoma or seroma, urinary hesitancy, neurostimulator turns on or off, lack of orgasm, lack of efficacy, numbness and tingling, foot/leg movement, strong anal sensation, unable to perceive stimulation, stress urinary incontinence, swollen feeling in abdomen, vaginal cramps, superficial connection, and possible skin perforation at neurostimulator. You should be aware that none of these problems in the clinical study resulted in permanent injury to patients. Additional information on clinical studies can be found at It is important to note that since this clinical study was conducted, changes in InterStim Therapy and surgical techniques have been made. For instance, the neurostimulator is now commonly placed in the upper buttock, rather than in the abdomen as in the original study. In addition, a new lead was developed which made the procedure much less invasive. Who Are Candidates for SNS Therapy? SNS is intended for patients who have failed or could not tolerate more conservative treatments. Bladder control problems that may improve with SNS therapy include: Overactive bladder (includes urge incontinence and urgency frequency-alone or in combination) Urge incontinence - The involuntary loss of urine associated with a sudden, strong desire to void (urgency). Urgency-frequency- Frequent, uncontrollable urges to urinate (urgency) and voiding often in very small amounts (frequency). Urinary retention - The inability to empty the bladder Fecal Incontinence The inability to control your bowels Who Are Not Candidates for SNS Therapy? InterStim Therapy is not intended to treat: Symptoms of stress incontinence. People with stress incontinence lose urine when they exercise, sneeze, cough, or laugh. Mechanical obstructions such as enlarged prostate (benign prostatic hypertrophy BPH), cancer or narrowing of the urethra (urethral strictures). Safety and effectiveness of InterStim Therapy has not been studied for stimulation with two leads, or for patients who are pregnant, have diabetes, neurological diseases or multiple sclerosis, or are under 16 years old. What Other Limitations Apply to SNS Therapy? Some known limitations for this therapy include: a failed test stimulation, or inability to use the patient programmer. Patients with other stimulation devices such as a pacemaker may also not be candidates for SNS. Inform anyone treating you that you CANNOT have an MRI without MRI protocol, any shortwave diathermy, microwave diathermy or therapeutic ultrasound diathermy (all now referred to as diathermy - local heating of the body tissues with an electric current for medical or surgical purposes), ) anywhere on your body because you have an implanted neurostimulation system. Energy from diathermy can be transferred through your implanted system, and can cause tissue damage, resulting in severe injury or death. Is SNS a Cure for Bladder Control Problems? As with any therapy, your own individual results may vary. While many patients implanted with InterStim Therapy experienced relief of many of their symptoms, the therapy will not result in complete improvement or a cure. You should know that many patients have experienced positive results and experienced an improved quality of life after having the InterStim Therapy implanted. To learn more about the therapy, visit or ask your doctor for the Medtronic patient manual and a brochure to read stories from patients who decided to have the InterStim System implanted. 5

8 Section 3: Preparing for Surgery Predetermination For InterStim Placement & Patient Responsibility Pre-determination must be submitted by mail to your insurance company for approval of the placement of the InterStim. In come cases it may take anywhere from 30 to 45 days for a decision to be made. In order for insurance to approve and/or pay for the placement of the InterStim, the following must be present and documented in the patient s record. The patient may need to assist in obtaining information from other providers in order to assure that criteria being met is documented in The Urology Team s patient chart. The patient has experienced urge continence for at least 12 months (the condition has resulted in significant disability; the frequency and/or severity of leakages are limiting the member s ability to participate in daily activities). Records from all other physicians (pcp, gyn, uro, etc.) will be needed to submit. The patient must have tried two pharmacotherapies that have either failed or are contraindicated. The patient must have tried pelvic floor exercises, behavior modification (timed voids and fluid management) or physical therapy. The patient must have a Bladder Diary (voiding times and fluid intake, etc.) which includes one diary before the placement of the temporary InterStim and one diary after the temporary placement to show at least 50% improvement. This must be delivered to the doctor s office for the pre-determination of the permanent placement of the InterStim. Insurance plans have different benefits or exclusions on each policy but the companies are looking for all of these guidelines to be present before considering payment. If you should receive a letter of approval from your insurance, please call ext. 392 to let us know so that we may proceed with scheduling. Urology Team Billing/Surgery Scheduling Process & Paperwork Needs The Urology Team surgery department schedules surgeries that are done outside our clinic. Below we have listed steps involved in getting you approved and scheduled for surgery. Your surgery coordinator will review this list with you and answer any questions you may have. Your communication and cooperation enables a smoother process and coordination of your surgery needs. 1. SCHEDULING SURGERY: The surgery scheduler coordinates your surgery needs taking into consideration insurance approved facilities, surgery type, facility availability, surgery time available as well as the physician s schedule. All these will be coordinated with you for approval. 2. PRE-OP INSTRUCTIONS: The surgery scheduler will also coordinate pre-op instructions with you. These include instructions specific to your surgery, the facility you are going to and insurance requirements. 3. INSURANCE: The surgery scheduler will pre-certify your surgery obtaining a pre-certification number if needed. The billing office will verify the physician s portion of your surgery expense which can include the patient s deductible or patient s coinsurance (the patient s responsbility for the procedure). Payment is due in our office prior to surgery date. The Urology Team accepts cash, check or major credit cards. *Please Note: Other fees outside The Urology Team physician s fee may include facility, anesthesia, lab, pathology and interpretation fees. These services will be billed by the appropriate entity. 6

9 Pre-Op Instructions 10 Days Prior To Surgery Stop taking Aspirin and any blood thinning products a full 10 days before your surgery. This includes Ibuprofen, Advil, Aleve, Coumadin, Plavix and any vitamin supplements (Vitamin E and Fish Oil). You may continue to take Tylenol for pain. Two to Seven Days Prior To Surgery Your physician may request that you have lab work and/or an EKG done prior to your surgery. Your physician will notify if this is required. Night Before Surgery You should not eat or drink anything after midnight the night before your surgery. This will insure that your surgery start time will not be delayed. Night Before Surgery Pack the InterStim booklet, supplied to you by The Urology Team, to take to the hospital. Pre-Op Hospital Visit Your Booklet After surgery you will be visited by a Medtronic representative, while In recovery, to discuss your InterStim device. The rep will go over the sheets named: InterStim Therapy Trial Assessment, InterStim Therapy Trial Assessment PNE Or InterStim Therapy Post Implant You will also be instructed on the importance of the Voiding Diary. Voiding Diary After your surgery, you will be required to complete a 7-day Voiding Diary. The Voiding Diary has been included as part of your patient package. This dairy records your voiding cycles and amounts during a 24-hour period over 7 days. The Voiding Diary should be started while you re in the hospital with your first urination with each implant stage. If you have disgarded the cup you were given prior to the transplant, please take the one provided by the hospital. This diary is very important as it will give your physician important information as to your voiding cycles post-surgery. At the same time, this diary will be submitted to your insurance company as verification of your symptom improvement. Please be sure to bring this diary to your post-surgery follow-up visit with your physician. 7

10 Ongoing Support & Care After Your Surgery Sacral Nerve Stimulation is delivered in two procedures: TEST (PERCUTANEOUS STAGE) to STAGE 1 & 2 or STAGE 1 to STAGE 2. Your follow-up care will depend on which process was used. TEST (PERCUTANEOUS STAGE) to STAGE 1 & 2 TEST (PERCUTANEOUS STAGE): Surgery Scheduling will schedule your follow-up appointments at the same time you are scheduled for surgery. In 3-10 days following surgery, your physician will access the wound site and review your diary results. At that time, the leads will be removed. If everything has been successful, you will be scheduled to proceed to Stage 1 & 2. STAGE 1 & 2: Your second visit will occur 1-3 weeks after your surgery to assess your wound and identify other programming needs. You should bring your voiding diary to this appointment to have it reviewed by the physician. STAGE 1 to STAGE 2 STAGE 1: The first visit with your physician will occur 3-5 days following surgery, at which the doctor will assess your wound site. It is vital that you bring your a completed voiding diary to this visit so that it can be reviewed by your doctor. STAGE 2: Your second visit will occur 1-3 weeks after your surgery to allow the doctor to assess your wound and to identify other programming needs. You will need to bring your voiding diary to this visit to be reviewed. MANAGEMENT AND ASSESSMENT OF YOUR INTERSTIM: If you have a problem, you can call at anytime for an appointment. You will be scheduled for a return appointment in six months, and then each year thereafter. BATTERY CHANGES A 5-10 year battery life is normal. A low battery symbol on the programmer will indicate when it is time to change the battery. InterStim / MRI Protocol Some patients with an InterStim device may require MRI testing. While it is preferable to avoid MRI in patients with an implantable device, this may not always be possible. If your doctor feels that an MRI is absolutely necessary, an MRI protocol will be followed. 1. Deactivate the magnet switch on the InterStim IPG (can only be performed by your InterStim doctor/implanting surgeon). 2. Use handheld device to decrease amplitude of generator all the way to zero (three successive beeps will be heard when zero is reached). 3. Turn off the InterStim IPG (after making sure it has been turned down to zero). 4. Use a lead shield over the pelvic area while in the MRI scanner. Limit the amount of time in the MRI scanner/machine to under one hour. If multiple MRI scans are requred and the time within the scanner would be more than one hour, then it is prudent to do them on different days to limit the scan time to less than one hour. Using this protocol, your physican has had no untoward events with MRIs in InterStim patients. However, one should always approach this issue cautiously and carefully and with full knowledge of your interstim physician and the MRI technician. 8

11 Section 4: Troubleshooting Answers to common questions about InterStim Therapy Is InterStim Therapy FDA approved? Yes. InterStim Therapy was approved by the FDA in 1997 for urge incontinence and in 1999 for urinary retention and significant symptoms of urgency-frequency. It has been available in the US for over a decade. Has InterStim Therapy been studied? Yes. InterStim Therapy has been shown to be safe and effective for people who have not had success with other treatments. It has been used to treat thousands of people worldwide. In a clinical study, doctors found that nearly half of patients with urge incontinence who received InterStim Therapy were completely dry after 6 months, and many others have experienced greatly reduced symptoms. Is InterStim Therapy for both men and women? Yes. InterStim Therapy can be used to treat urinary control symptoms in both men and women. Will my insurance cover the costs? Medicare and many other private insurance companies cover InterStim Therapy. Your out-of-pocket costs will vary according to your insurance plan. Check with you insurance provider about the details of your coverage. How will I know if it will work for me? A trial assessment period lets you test InterStim Therapy to see if it will work for you before making a long-term commitment. The trial assessment is considered a success if you experience a significant reduction in your symptoms. For example, your trial may be considered a success if you went to the bathroom 20 times per day before the trial and went 10 or fewer times during the trial. How will InterStim Therapy impact my daily life? InterStim Therapy can eliminate or greatly reduce bladder control symptoms for people suffering from overactive bladder (urge incontinence, urgency-frequency) or urinary retention problems. InterStim Therapy may allow you to regain your everyday freedom, so you can stop worrying about your bladder control problems and return to the life you once enjoyed. Your doctor will inform you of precautions and activity restrictions related to InterStim Therapy. You cannot have diathermy while you are receiving InterStim Therapy. Will InterStim Therapy cure my condition? No. InterStim Therapy is a treatment for bladder control problems, not a cure. If the neurostimulator were turned off or removed, your symptoms would return. How will I know my model number? The day of your surgery you will receive a temporary device card. A permanent one will be supplied to you by a Medtronic representative. Under what circumstances should I turn off the device? Turn your neurostimulator OFF when having a medical or dental procedure, when going through theft detectors and security screening devices, or when using potentially dangerous equipment. Contact Information and Times The Urology Team offices are open Monday Friday from 8:00 am to 4:30 pm. You may contact the office at or toll-free. If you have questions, or need assistance from 4:30 pm to 8:00 am, contact Medtronic at Your call will go to voic and will be returned by a Medtronic representative on the next available business day. Be prepared to give the Medtronic representative your InterStim device name and model number. If you feel your call is an emergency, call 911 or go to the nearest emergency room. Information obtained from 9

12 Voiding Diary The Voiding Diary should be started while you re in the hospital with your first urination with each implant stage. This diary is very important as it will give your physician important information as to your voiding cycles post-surgery. At the same time, this diary will be submitted to your insurance company as verification of your symptom improvement. Please be sure to bring this diary to your post-surgery follow-up visit with your physician. Name: Day 1 Date: Time of Day Voided Catheter Did you feel empty? Fluid Intake # of pads used per day Additional Comments

13 Voiding Diary The Voiding Diary should be started while you re in the hospital with your first urination with each implant stage. This diary is very important as it will give your physician important information as to your voiding cycles post-surgery. At the same time, this diary will be submitted to your insurance company as verification of your symptom improvement. Please be sure to bring this diary to your post-surgery follow-up visit with your physician. Name: Day 2 Date: Time of Day Voided Catheter Did you feel empty? Fluid Intake # of pads used per day Additional Comments

14 Voiding Diary The Voiding Diary should be started while you re in the hospital with your first urination with each implant stage. This diary is very important as it will give your physician important information as to your voiding cycles post-surgery. At the same time, this diary will be submitted to your insurance company as verification of your symptom improvement. Please be sure to bring this diary to your post-surgery follow-up visit with your physician. Name: Day 3 Date: Time of Day Voided Catheter Did you feel empty? Fluid Intake # of pads used per day Additional Comments

15 Voiding Diary The Voiding Diary should be started while you re in the hospital with your first urination with each implant stage. This diary is very important as it will give your physician important information as to your voiding cycles post-surgery. At the same time, this diary will be submitted to your insurance company as verification of your symptom improvement. Please be sure to bring this diary to your post-surgery follow-up visit with your physician. Name: Day 4 Date: Time of Day Voided Catheter Did you feel empty? Fluid Intake # of pads used per day Additional Comments

16 Voiding Diary The Voiding Diary should be started while you re in the hospital with your first urination with each implant stage. This diary is very important as it will give your physician important information as to your voiding cycles post-surgery. At the same time, this diary will be submitted to your insurance company as verification of your symptom improvement. Please be sure to bring this diary to your post-surgery follow-up visit with your physician. Name: Day 5 Date: Time of Day Voided Catheter Did you feel empty? Fluid Intake # of pads used per day Additional Comments

17 Voiding Diary The Voiding Diary should be started while you re in the hospital with your first urination with each implant stage. This diary is very important as it will give your physician important information as to your voiding cycles post-surgery. At the same time, this diary will be submitted to your insurance company as verification of your symptom improvement. Please be sure to bring this diary to your post-surgery follow-up visit with your physician. Name: Day 6 Date: Time of Day Voided Catheter Did you feel empty? Fluid Intake # of pads used per day Additional Comments

18 Voiding Diary The Voiding Diary should be started while you re in the hospital with your first urination with each implant stage. This diary is very important as it will give your physician important information as to your voiding cycles post-surgery. At the same time, this diary will be submitted to your insurance company as verification of your symptom improvement. Please be sure to bring this diary to your post-surgery follow-up visit with your physician. Name: Day 7 Date: Time of Day Voided Catheter Did you feel empty? Fluid Intake # of pads used per day Additional Comments