Managing Complications after Midurethral Sling for Stress Urinary Incontinence

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1 eau-ebu update series 5 (2007) available at journal homepage: Managing Complications after Midurethral Sling for Stress Urinary Incontinence Elisabetta Costantini *, Massimo Lazzeri, Massimo Porena Department of Medical-Surgical Specialties and Public Health, Section of Urology and Andrology, University of Perugia, Perugia, Italy Article info Keywords: Complications Midurethral sling Stress urinary incontinence Therapy Abstract Since Ulmsten and Petros s original description of the tension-free vaginal tape (TVT) procedure in 1995, the midurethral sling (MUS) has become first-line therapy for correction of female stress urinary incontinence (SUI). Cure rates are high for TVT and the recent tension-free trans-obturator tape (TOT) procedures, and the incidence of side effects is low. In the past few years although several studies have dealt with the incidence and prevalence of MUS-related complications, their surgical management remains an open issue. This paper presents the rationale for surgical management of MUS-linked complications, updates progress in new strategies, and tracks translation of recommendations on vaginal and urethral erosion, postoperative voiding difficulties, and de novo urgency into clinical practice. # 2007 European Association of Urology and European Board of Urology. Published by Elsevier B.V. All rights reserved. * Corresponding author. Department of Medical-Surgical Specialties and Public Health, Section of Urology and Andrology, Via Brunamonti 51, Perugia, Italy. Tel ; Fax: address: [email protected] (E. Costantini). 1. Introduction Since Ulmsten and Petros s original description in 1995 of the tension-free vaginal tape (TVT) procedure [1] for female stress urinary incontinence (SUI) many other techniques, materials, and approaches have been described [2]. The safety and efficacy of TVT and the more recent trans-obturator tape (TOT) procedures have been extensively investigated [3], but only a few reports have dealt with the true incidence and prevalence of complications [4] and even fewer with their management [5]. Urologists, gynaecologists, patients, health funding institutions, and health policy makers are striving to identify specific indicators for assessing and improving the quality of care in SUI. Surgery for female pelvic organ prolapse (POP) and SUI must be successful if quality of life (QOL) is to improve because failure and complications may have devastating effects on patients. Olsen et al reported that women have an 11% lifetime risk of one operation for POP or urinary incontinence; 29% of patients who undergo surgery risk a second operation, 31% risk a third, 41% risk a fourth, and 67% risk a fifth operation [6]. As risk rises with failure and MUS-related complications, estimating their true incidence and prevalence and quickly recognising and managing them properly are key factors in quality of care improvements in patients who undergo surgery for SUI /$ see front matter # 2007 European Association of Urology and European Board of Urology. Published by Elsevier B.V. All rights reserved. doi: /j.eeus

2 eau-ebu update series 5 (2007) This paper reviews the incidence and prevalence of MUS-related complications and addresses the rationale for their surgical management, updates progress in new conservative and operative strategies for treating complications, and tracks translation of recommendations about vaginal and urethral erosion, postoperative voiding difficulties, and ex novo urgency into clinical practice. 2. Definition and epidemiology of SUI The International Continence Society defines SUI as involuntary urine leakage on effort, exertion, sneezing, or coughing and mixed urinary incontinence (MUI) as involuntary leakage associated with urgency (a sudden, compelling desire to pass urine, which is difficult to defer), exertion, effort, sneezing, or coughing ( The prevalence of urinary incontinence ranges from 2% to 55%, depending on definition, type, data collections, sex, and ethnic group. In communitydwelling women it ranges from 10% to 40% but reaches 50% in elderly women and in institutiondwelling adults [7]. SUI is reported to account for 49% of female urinary incontinence, urgency incontinence for 22%, and MUI for 29%. The Norwegian Epidemiology of Incontinence in the County of Nord- Trondelag (EPINCONT) study reported a 4.7% incidence of SUI in nulliparous women but noted it increased to 12.2% in women who had undergone vaginal delivery [8]. Although the prevalence of urinary incontinence may be surprising to many clinicians, women often underreport or delay seeking treatment for several years after the problem has become bothersome. Incontinence has a major impact on QOL, which is often not appreciated by health care providers [9]. Finally, complications after surgery for SUI may drive QOL to a level below the patient s preoperative status. 3. Pathophysiology Urologists and gynaecologists need to be aware that many aspects of the mechanism of female continence are still not clear. Normal continence in women is a complex coordination of the bladder, urethra, pelvic muscles, and surrounding connective tissues. The urethra, a 3- to 4-cm long tube, passes urine during the voiding phase of the micturition reflex and maintains sufficient pressure to prevent urine leakage during the storage phase or during physiologic increases of abdominal pressure such as coughing or physical activities. These two functions depend on central, peripheral autonomic (sympathetic and parasympathetic systems) and somatic neuronal control and local peripheral factors. Pelvic muscles and ligaments also contribute to urinary continence. Levator ani contraction pulls the vagina forward toward the pubic symphysis, creating a stable urinary tract backstop, which compresses the urethral walls and prevents urine leakage during coughing or similar intra-abdominal pressure increases. Tissue connecting the urethra and bladder neck to the vagina and pubic symphysis supports and prevents leakage. In their integral theory of female urinary incontinence, involving different pelvic organs and the perineum, Petros and Ulmsten [10] hypothesised that stress and urgency incontinence both originate from vaginal laxity, which may be caused by intrinsic defects within the vagina wall itself, or to the ligaments, muscles, and connective tissue insertions that constitute its supporting structures. They concluded that the vagina has a dual function: it mediates or transmits muscle movements to the bladder neck, permitting a valid opening and closure mechanism, and its structure prevents urgency by supporting hypnotised stretch receptors at the proximal urethra and bladder neck. Thus, altered collagen or elastin content in vaginal tissue or in its ligaments might cause SUI or activate uninhibited detrusor contractions. Under normal conditions some of the afferent/ efferent signal pathways to and fro between the lower urinary tract and higher neural centers, the relationship between anatomic support and function, and the ability of the continence mechanism to adapt and repair after childbirth or neurologic injuries, also need to be considered. In women with complications after MUS, urologists and gynaecologists also must factor in acute or chronic inflammation status, sling materials, and the host mesh relationship. SUI originates when, during sudden increases of intra-abdominal forces, bladder pressure exceeds urethral pressure. Urine leakage may derive from loss of backstop support at the bladder neck (bladder-neck hypermobility) or from intrinsic sphincter defeat, that is, the loss of muscular tone at rest, which is termed low-pressure urethra or intrinsic sphincter deficiency. In the TVT and TOT era urologists learned that grouping patients into these two dichotomous categories does not translate into different therapeutic strategies. SUI varies between the extremes of intrinsic sphincter deficiency and bladder-neck hypermobility, with most patients presenting both disorders.

3 234 eau-ebu update series 5 (2007) In conclusion, SUI might be due to childbirth, labor, and obstetric injuries to perineal muscles, connective tissue, and nerves resulting in inability to support the bladder neck. Vascular damage that might affect muscles and nerves, ageing, and risk factors such as obesity are major factors in the pathogenesis of SUI. Urologists and gynaecologists need to know that treating MUS-related complications (ie, erosion) may result in a return to incontinence, which will be very difficult to reconvert into urinary continence. 4. Complications MUS procedures have gained popularity not only because success rates are high, but also because complication rates appear low. Major and minor complications remain, however, a discussion point and a diagnostic and therapeutic challenge for even the most skilled urologist and gynaecologist. Table 1 presents the percentage range of complications after MUS procedures, according to reports; Table 2 summarises the main symptoms of early and late complications; and Table 3 describes the aetiology of complications. Several variables have an impact on the epidemiology of MUS-related complications. Lack of worldwide national registers of all MUS procedures means that often investigators do not have the denominator for calculating the true incidence of Table 1 Complications after midurethral sling procedures Intraoperative Major Vascular lesions < 0.01% Nerve injuries < % Gut lesions < 0.007% Minor Bladder injury % Repeated bladder injury 1.2% Perioperative Retropubic haematoma 2 4.3% Blood loss > 200 ml % Urinary tract infections 10% Spondylitis % Postoperative Transient urinary retention % Permanent urinary retention % Vaginal erosion % Urethral erosion % De novo urgency % Bladder erosion % Urethral obstruction % Ranges are as reported in the literature. Table 2 Signs and symptoms of complications after midurethral sling procedures Complications Obstruction Bladder erosion Vaginal erosion De novo urgency Urethral erosion Symptoms Postvoid residue urine Straining to void Incomplete bladder empty Recurrent urinary tract infections Urgency Poor stream Haematuria Pain (suprapubic/urethra) Infection Pain Dyspareunia Dysuria Urinary tract infections Vaginal discharge Vaginal bleeding Frequency Urgency Nocturia Urgency incontinence Pain Urethral bleeding Urethral discharge Infections Urgency Poor stream complications; a discrepancy exists between complication rates in scientific reports and independent databases such as the Manufacturer and User Facility Device Experience (MAUDE), which monitors voluntary reporting of MUS-related complications. Deng et al recently investigated the incidence of major MUS-related complications in the American population and found they were underreported. A significant discrepancy emerged between scientific reports in English and Food and Drug Administration (FDA)/ MAUDE reports, which collected four times as many major complications [4]. The impressive paucity of major complications in reports gave a false sense of security. Several explanations may be found: (1) reports may understate complications, (2) surgeons who have higher complication rates do not answer questionnaires, (3) differences exist between high- and low-volume surgeons, and (4) underreporting or over-reporting complication rates might be accounted for by surgeons who manage the complications. Another issue is timing of complications. Hammad et al [11] reported that 35% of vaginal erosions were asymptomatic and erosion was discovered on routine follow-up, not during a symptom check-up. Kobashi et al seemed to confirm these data. In > 90 women who received a polypropylene mesh for the

4 eau-ebu update series 5 (2007) Table 3 Aetiology of midurethral sling-related complications Complications Vaginal erosion Urethral erosion Bladder perforation Aetiology Inadequate suturing of vaginal wall Extensive dissection Early resumption of sexual activity Previous vaginal surgery Wound infection Incorrect vaginal plane Rolling of the tape Ischaemia Excessive tension Ischaemia Extensive dissection around urethra Previous surgery Infection Incorrect plane of dissection Rolling of the tape Operative technique treatment of SUI, 3 developed vaginal erosion, but only 1 had symptoms such as pain, discomfort during sexual activity, and vaginal discharge and erosion was discovered during a routine check-up [12]. Similar data were also reported for urethral erosion, even though the percentage of asymptomatic erosion was 11%. Generally, however, 66% of whole erosion is discovered within the first 3 mo after surgery. Urologists and gynaecologist must be aware that in a high percentage of cases signs and symptoms of complications often begin early after surgery and the surgeon needs to understand and recognise them to offer the best treatment as soon as possible. Performance of new surgical tasks improves with experience over time. This learning curve presents particular difficulties in the modern health technology era [13]. Many surgeons who apply new minimal access approaches are often reluctant to apply rigorous evaluation to a new procedure whose outcome and complication rates may change with learning curves [14]. In MUS a study of the learning curves might allow adjustments to be made to earlier assessments of complications. In an analysis of the complication rate in 140 female patients who underwent the suprapubic arc (SPARC) operation for SUI [15], Kobashi et al found timing of complications did not seem to correlate with learning curves and concluded complications were probably more inherent to technique than a reflection of experience. Comorbidities have been reported to increase the incidence of complications. Boyles et al [16] showed that comorbidities, such as diabetes and vascular diseases, were associated with a 2-fold increase in the risk of major (but not minor) complications (sepsis, pulmonary failure, thromboembolic events, and myocardial infarction). Obesity (body mass index [BMI] 35 kg/m 2 ) might increase technical difficulty and complication rates. In 43 obese patients and 35 matched, nonobese women who were treated with TVT, Lovatsis et al [17] observed that obesity did not increase the risk of local complications. On the other hand, Skriapas et al [18] found deep vein thrombosis, arrhythmia, and pneumonia were more frequent in obese patients. Another important comorbidity, which could increase the risk of local complications, is earlier radiation for gynaecologic cancers. Bleeding is another issue. Data from a national registry of 5578 patients who underwent TVT, reported 151 patients (2.7%) suffered from bleeding and 45 patients required reintervention or procedure conversion [19]. Suprapubic ultrasound in 31 asymptomatic patients after TVT visualised haematomas > 5 cm in 16% [20]. Another open question is whether TOT is associated with fewer complications than retropubic slings. Laurikainen et al [21] reported that patients who underwent TVT-O had a significantly longer hospital stay, needed significantly more postoperative opiate analgesia, and had significantly more complications than patients in the TVT group, but these significantly higher complication rates were not regarded as clinically significant. Zullo et al [22] recently reached the opposite conclusion. Perioperative complications were significantly more common after the retropubic approach (5% and 27% in TVT-O and TVT groups, respectively, p < 0.04); TVT-O had a shorter operating time and lower overall perioperative complication rates. TVT, however, seems to be associated with a higher obstructive voiding dysfunction, with an incidence ranging from 17% to 50%, and its treatment remains one of the main challenges for urologists and gynaecologists. Boyles et al [23] analysed complications associated with TOT slings as reported in the MAUDE register, a national US database that collects reports of complications associated with medical devices, which is maintained by the FDA. Previously unreported complications, such as obturator nerve injuries, large blood loss ( 600 cc), and ischiorectal fossa abscesses were associated with different, commercially available trans-obturator slings. Another important concern is emergence of ex novo urgency after anti-incontinence sling placement. In a multivariate analysis, Botros et al [24] found TOT was associated with less ex novo urgency and urge urinary incontinence (UUI). It significantly

5 236 eau-ebu update series 5 (2007) increased the chance of resolving preoperative UUI compared with retropubic procedures; UUI symptoms worsened in 6% of subjects after TOT compared with 14 16% after TVT/SPARC. The hypothesis that tape location closer to the bladder neck correlated with a higher risk of voiding dysfunction or complications was not confirmed. Voiding dysfunction is more likely to occur if the tape is too tight, that is, too close to the urethra. Ultrasound studies have demonstrated midurethral tape position in 85.7% of patients. Variations in tape placement seemed to have little effect on symptoms. Finally, sling material plays a fundamental role in the genesis and management of complications. Several papers have reviewed this topic and Tables 4 and 5 summarise the characteristics and the pros and cons of different materials [25]. Generally speaking synthetic nonabsorbable materials Table 4 Pros and cons of substitution materials depending on their origin Mesh Categories Material Brand name Pros Cons Synthetic Absorbable Polyglactin acid Vicryl Low risk of erosion Poor scar formation Low risk of infection Poor tensile strength High failure rate Polyglycolic acid Dexon Low risk of erosion Poor scar formation Low risk of infection Poor tensile strength High failure rate Nonabsorbable Polypropylene Prolene Large size pores Tissue fixity (1500 mm) Flexible Scars Lower risk of erosion High tissue conformity Marlex Smaller size pores Erosion (600 mm) Polyester Dacron High resistance (strong) Fray Good memory Poor tissue conforming InteMesh Erosion (silicone-coated) Protogen High erosion rate (recalled in 1999) Silicone Silastic Smoother High host rejection Increase the Fibrous sheath Poor long-term resistance Polytetrafluoroethylene Gore-Tex Erosion Polyethylene Mersilene Inflammatory terephthalate reaction Nonsynthetic Autograft Rectus fascia Naïve tissue Patients morbidity Easy to harvest Recovery time Durable Increase collagen synthesis Sling contraction Fibroblast penetration Fascia lata Long specimens Higher operative time Uniform in thickness Infection Avoids abdomen Collagen degradation incision Allograft Cadaveric fascia lata Tutoplast Low patient morbidity Prion and virus infection Alloderm Low operative time Rejection Cadaveric dermis Low patient morbidity Prion and virus transmission Low operative time Rejection Low erosion rate Xenograft Porcine tissue Dermis (Derm-Matrix, Pelvicol, Pelvisoft) Small intestine submucosa (Surgisis) Bovine tissue Dermis (Xenform) Pericardium (Peri-guard, Veritas, Uropatch) High tensile strength High biocompatibility High tensile strength High biocompatibility Prion and virus transmission Prion and virus transmission

6 eau-ebu update series 5 (2007) Table 5 Pore size classification of mesh Type 1 Type 2 Type 3 Type 4 Large-sized pores (> 75 mm) It allows admission of macrophages and ingrowth of fibroblasts (fibroplasias) blood vessels (angiogenesis) and collagen. Medium-sized pores (10 mm) It has a structure, which does not permit the immunocell migration; it is encapsulated by host tissue. Large- and medium-sized pores It has a complex structure including large- and medium-sized pores and it includes multifilament material. Small size pores (< 1 mm) Not used as mesh. are plagued with a higher incidence of erosion, infection, and fistula. Comiter et al reported that the urethral erosion rate might be 10 times greater with synthetic materials than with organic slings [26]. Woven materials are claimed to have greater complication rates than nonwoven materials. Multifilament tapes may increase the risk of infection and vaginal erosion. Micropore multifilaments, which are more flexible, less extensible, and easier to adjust, may be associated with a lower incidence of obstruction [27]. Polypropylene tends to have a lower complication rate (0 5%) than polytetrafluoroethylene (Gore-Tex), polyester (Dacron), or silicone (4 30%). The efficacy of a polypropylene MUS in restoring continence depends on its biomechanical properties before and after implantation. Complications, such as erosion and infection, which are due to local inflammatory reactions, reflect its biocompatibility (Table 6). A sling s biologic characteristics, that is, how well it incorporates within native tissue, is the main factor predicting erosion [2]. 5. Treatment of complications Mesh erosion, one of the most frequent complications, can be managed with conservative or nonconservative strategy, depending on the erosion site and extension, mesh material, and patient s clinical status. Oestrogen therapy in small vaginal erosion may favour spontaneous healing or prepare the vagina for surgical repair. However, in women receiving oestrogen therapy, mesh erosion increased when hysterectomy was associated with sacral colpopexy [28]. Surgical approach ranges from partial, simple excision of the exposed mesh to surgical exploration for total graft removal and tissue reconstruction with a Martius flap. According some authors, polypropylene tape erosion should be treated with complete mesh removal, without regard to erosion site, width, or local tissue condition [29]. Explantation is recommended when erosion involves the lower urinary tract (bladder or urethra), independently of sling materials [30,31]. Vaginal erosion of synthetic materials, such as polyester and silicone slings, should also be treated with mesh removal because epithelialisation over these materials is unlikely [12,31,32]. However, when erosion is limited to the vagina, conservative management with observation might be a viable option [31] if the sling were made of autologous, allograft and new, loosely woven polypropylene material because the latter provides large interstices, which favour tissue ingrowth and healing. Furthermore, the self-fixing nature of polypropylene may allow the graft to integrate into surrounding tissues without other complications, which could occur more frequently with tightly woven meshes. When a conservative approach is scheduled two questions remain. How long should one reasonably wait for epithelialisation and what is the maximal area of sling exposure to consider for conservative management? Kobashi et al suggested that when the vaginal epithelium appears to cover the mesh but has not completely grown over all of it, further observation might be considered rather than sling removal. Up to approximately 1 cm of mesh exposure should become epithelialised within 6 wk; larger exposed areas could become epithelialised after a longer observation period [12]. Consequently, when the erosion involves the vagina and is 1cm, one should preserve the sling. If no starting or partial Table 6 Biocompatibility of polypropylene mesh Brand Inflammatory infiltrate Fibrosis Muscular infiltration Mast cell presence Collagen filling Advantage monofilament type 1 Moderate Extensive Extensive High Minimal (< 25%) IVS multifilament type 3 Moderate Moderate Moderate Low Partial (25 50%) SPARC monofilament type 1 Extensive Extensive Extensive High Minimal (25%) TVT monofilament type 1 Low Very low Low Moderate High (> 50%) IVS = intravaginal slingplasty; SPARC = suprapubic arc; TVT = tension-free vaginal tape. TVT has the highest biocompatibility. Inflammatory infiltrate and fibrosis are considered parameters of rejection.

7 238 eau-ebu update series 5 (2007) overgrowth is evident by 3 mo postoperatively, sling removal should be seriously considered. When one decides to adopt a conservative strategy for sling erosion, the patients need careful counselling about the risks, benefits, and alternatives. Patients must be informed of the ideal outcome of sling preservation versus the opposite scenario of failure of the sling to epithelialise despite prolonged abstinence from intercourse. A wound-healing vaginal defect may be a challenging complication, particularly in obese, diabetic, or immunocompromised patients. Because chronic tape inflammation is the main cause of disturbed wound healing, vaginal resection of the periurethral parts of the tape is mandatory. Ex novo urgency, although claimed to be the complication with the strongest negative impact on QOL, is sometimes self-limiting. When a patient complains of urgency after surgery, the surgeon must rule out and remove specific causes of urgency, such as urethral erosion, intravesical tape, urinary retention, or recurrent urinary tract infections. If urgency and UUI persist, oral antimuscarinic agents are first-line therapies. Should they fail, alternatives (intravesical vanilloids, intradetrusor injection of botulinum toxin, and sacral neuromodulation) may be proposed. Postoperative obstruction is another challenging complication. Early postoperative transient urinary retention, which may require intermittent sterile self-catheterisation, tends to resolve within 12 wk with restoration of complete bladder emptying in the majority of cases. If urinary retention or subvesical obstruction with high postvoid residual volume persists after 12 wk and is due to excessively tight mesh, tape transvaginal urethrolysis may be performed. Klutke et al described suburethral tape transaction under local anaesthesia without further resection and mesh release without transaction for treating persistent postoperative urinary retention [5]. In this series, 16 of 17 patients treated with either technique voided completely after therapy and remained continent and the other patient with intraoperative urethral damage needed a further reconstruction. Volkmer et al [33] confirmed these data, reporting that patients with obstruction remained continent after sling transaction and suggesting periurethral sling resection could destroy the scars that replaced the urethropubic ligaments and could lead to urinary incontinence. Few (0.6% of 9040 patients) need tape transaction for persistent urinary retention [34]. SUI recurrence after tape release remains an open issue and at present there is no consensus on severity, voiding dysfunction duration, and timing of tape release. Professional experience and the patient s clinical status should guide decisions on timing. Bladder perforation is a perioperative complication that has been described as prevalent after TVT. Bladder perforation usually does not need any further therapy except catheter drainage for 2 4 d. Bladder erosion that is not evident at cystoscopy but emerges weeks later is due to submucosally placed tape with secondary erosion. Polypropylene mesh contact with urine always leads to tape incrustation without any possibility of correcting the tape position so the mesh must be removed. The earlier a misplaced tape is explanted, the fewer the scars, the less inflammation that will develop, and the easier complete removal will be [2]. In selected, complicated cased, that is, associated with stones, bleeding, or recurrent infection, an open suprapubic approach with cystotomy is recommended to ensure access to the intravesical parts of the tape. Surgical evacuation of Retzius haematoma is rare. Bleeding usually originates from pelvic floor veins or epigastric vessels and evacuation is decided on the basis of the patient s clinical condition. Case reports have described more severe complications that required immediate surgical intervention, such as perforation of the small intestine [35], external iliac vein [36], or obturator nerve [37]. Although the risk of such extraordinary injuries remains low, it is important to keep them in mind. Finally, other case reports showed obturator abscess, perineal and tight abscess, and necrotising fascitis, which required specific antibiotic therapy and eventually surgical drainage. 6. Conclusion Minimally invasive treatment of SUI is not entirely free of severe, long-lasting complications. A close, long-term follow-up is paramount for improving the patients QOL. Physicians who evaluate women presenting with complications after they have had a surgical procedure for SUI need excellent clinical skills in the medical and surgical management of all MUS-related adverse effects. Acknowledgement The authors would like to thank Dr Geraldine A. Boyd for editing this paper. Conflicts of interest The authors have nothing to disclose.

8 eau-ebu update series 5 (2007) References [1] Ulmsten U, Petros P. Intravaginal slingplasty (IVS): an ambulatory surgical procedure for the treatment of female urinary incontinence. Scand J Urol Nephrol 1995;29: [2] Bazi TM, Hamade RF, Abdallah I, Hussein H, Abi Nader K, Jurjus A. Polypropylene midurethral tapes do not have similar biologic and biomechanical performance in rat. Eur Urol 2007;51: [3] Delorme E. Transobturator urethral suspension: miniinvasive procedure in the treatment of stress urinary incontinence in women. Prog Urol 2001;11: [4] Donna D, Rutman M, Raz S, Rodriguez LV. Presenting and management of major complications of mid-urethral slings: are complications under-reported. Neurourol Urodynam 2007;26: [5] Klutke C, Siegel S, Carlin B, Paszkiewicz E, Kirkemo A, Klutke J. Urinary retention after tension-free vaginal tape procedure: incidence and treatment. Urology 2001;58: [6] Olsen AL, Smith VJ, Bergstrom JO, Colling JC, Clark AL. 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Eur Urol 2005;47: [12] Kobashi KC, Govier FE. Management of vaginal erosion of polypropylene mesh slings. J Urol 2003;169: [13] Banta D, Wle PA. Health care technology and its assessment: an international perspective. Oxford, United Kingdom: Oxford University Press; [14] Stirrat GM, Farrow SC, Farndon J, Duyer N. The challenge of evaluating surgical procedures. Ann R Coll Surg Engl 1992;74:80 4. [15] Kobashi KC, Govier FE. Perioperative complications: the first 140 polypropylene pubovaginal slings. J Urol 2003;170: [16] Boyles SH, Weber AM, Meyn L. Ambulatory procedures for urinary incontinence in the United States, Am J Obstet Gynecol 2004;190:33 6. [17] Lovatsis D, Gupta C, Dean E, Lee F. Tension-free vaginal tape is an ideal treatment for obese patients. Am J Obstet Gynecol 2003;189: [18] Skriapas K, Poulakis V, Dillenburg W, et al. Tension-free vaginal tape (TVT) in morbidly obese patients with severe urodynamic stress incontinence as last option treatment. 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Int Urogynecol J Pelvic Floor Dysfunct 2007;18: [24] Botros SM, Miller JR, Goldberg RP, et al. Detrusor overactivity and urge urinary incontinence following trans obturator versus midurethral slings. Neurourol Urodynam 2007;26:42 5. [25] Trabuco EC, Klingele CJ, Gebhart JB. Xenograft use in reconstructive pelvic surgery: a review of the literature. Int Urogynecol J Pelvic Floor Dysfunct 2007;18: [26] Comiter CV, Colegrove PM. High rate of vaginal extrusion of silicone-coated polyester sling. Urology 2004;63: [27] Meschia M, Pifarotti P, Bernasconi F, et al. Tension-free vaginal tape (TVT) and intravaginal slingplasty (IVS) for stress urinary incontinence: a multicenter randomized trial. Am J Obstet Gynecol 2006;195: [28] Wu JM, Wells EC, Hundley AF, Connolly A, Williams KS, Visco AG. Mesh erosion in abdominal sacral colpopexy with and without concomitant hysterectomy. Am J Obstet Gynecol 2006;194: [29] Sweat SD, Itano NB, Clemens JQ, et al. Polypropylene mesh tape for stress urinary incontinence: complications of urethral erosion and outlet obstruction. J Urol 2002;168: [30] Clemens JQ, DeLancey JO, Faerber GJ, Westney OL, McGuire EJ. Urinary tract erosions after synthetic pubovaginal slings: diagnosis and management strategy. Urology 2000;56: [31] Duckett JRA, Constantine G. Complications of silicone sling insertion for stress urinary incontinence. J Urol 2000;163: [32] Stanton SL, Brindley GS, Holmes DM. Silastic sling for urethral sphincter incompetence in women. Br J Obstet Gynaecol 1985;92: [33] Volkmer BG, Nesslauer T, Rinnab L, Schradin T, Hautmann RE, Gottfried HW. Surgical intervention for complications of tension-free vaginal tape procedure. J Urol 2003;169:570 4.

9 240 eau-ebu update series 5 (2007) [34] Laurikainen E, Kiilhoma P. A national analysis of transvaginal tape release for urinary retention after tension free vaginal tape procedure. Int Urogynecol J Pelvic Floor Dysfunct 2006;17: [35] Peyrat L, Boutin JM, Bruyere F, Haillot O, Fakfak H, Lanson Y. Intestinal perforation as a complication of tension free vaginal tape procedure for urinary incontinence. Eur Urol 2001;39: [36] Primicerio M, De Matteis G, Montanino Oliva M, et al. Use of the TVT (tension-free vaginal tape) in the treatment of female urinary stress incontinence. Preliminary results. Minerva Ginecol 1999;51: [37] Meschia M, Pifarotti P, Bernasconi F, et al. Tension-free vaginal tape: analysis of outcomes and complications in 404 stress incontinent women. Int Urogynecol J Pelvic Floor Dysfunct Suppl 2001;12:S24 7. CME questions Please visit to answer these CME questions on-line. The CME credits will then be attributed automatically. 1. What is a woman s lifetime risk of a second operation after a surgery for correction of pelvic organ prolapse or urinary incontinence? A. 15% B. 19% C. 29% D. 54% 2. The theory of integral therapy states that A. Both stress and urgency incontinence may be due to vaginal laxity caused by defects within the vaginal wall or its supporting structures, for example, ligaments, muscles, and connective tissue. B. Stress but not urge incontinence may be due to vaginal laxity caused by defects within the vaginal wall or its supporting structures, for example, ligaments, muscles, and connective tissue insertions. C. Urge incontinence but not stress urinary incontinence may be due to vaginal laxity caused by defects within the vaginal wall or its supporting structures, for example, ligaments, muscles, and connective tissue. D. Both stress and urgency incontinence may be due to neuronal control failure, which is responsible for functional integration of pelvic organs. 3. Obesity increases the risk of A. Vaginal and/or urethral erosion. B. Ex novo urgency. C. Urinary tract infection. D. Deep vein thrombosis. 4. The management of erosion involving the urinary tract is A. Explantation of all sling materials. B. Oestrogen plus antibiotic therapy. C. Placement of suprapubic catheter and antibiotic therapy. D. Suturing erosion edges. 5. In vaginal erosion slings made of which materials have to be removed? A. Autologous. B. Polyester. C. Allograft. D. Loosely woven polypropylene. 6. What percentage of patients require tape release because of persistent urinary retention? A. 0.6% B. 3.2% C. 4.5% D. 7.8%