Durable improvements in urinary incontinence and positive treatment response in patients with idiopathic overactive bladder syndrome following long-term onabotulinumtoxinA treatment: Final results of 3.5-year study.

OBJECTIVES: Here we present the final results from an extension study assessing long-term onabotulinumtoxinA treatment (3.5 years) in patients with idiopathic overactive bladder. METHODS: Patients who completed either of 2 Phase III trials were eligible to enter a 3-year extension study in which they received multiple onabotulinumtoxinA (100 U) treatments. Data were analyzed for the overall population of patients who received 100 U in any treatment cycle (n=829) and within discrete subgroups of patients who received exactly 1 (n=105), 2 (n=118), 3 (n=117), 4 (n=83), 5 (n=46), or 6 (n=33) treatments of the 100 U dose throughout the study (n=502). RESULTS: Of the 829 patients enrolled, 51.7 % completed the study. Discontinuations due to AEs/lack of efficacy were low (5.1/5.7 %); other reasons were not treatment-related. Mean reductions from baseline in urinary incontinence (UI) episodes/day (week 12; co-primary endpoint) were consistent among discrete subgroups who received 1 (-3.1), 2 (-2.9, -3.2), 3 (-4.1 to -4.5), 4 (-3.4 to -3.8), 5 (-3.0 to -3.6), or 6 (-3.1 to -4.1) treatments. A consistently high proportion of patients reported improvement/great improvement on the Treatment Benefit Scale (week 12; co-primary endpoint) in the discrete subgroups across all treatments (70.0-93.5 %). Median time to request retreatment was ≤6 months for 34.2 %, >6-≤12 months for 37.2 %, and >12 months for 28.5 % of patients. Most common AE was UTI, with no changes in safety profile over time. CONCLUSION: Long-term onabotulinumtoxinA treatment resulted in consistent reductions in UI and high proportions of patients reporting improvement after each treatment, with no new safety findings.

OnabotulinumtoxinA 100U provides significant improvements in overactive bladder symptoms in patients with urinary incontinence regardless of the number of anticholinergic therapies used or reason for inadequate management of overactive bladder.

INTRODUCTION: A prespecified pooled analysis of two placebo-controlled, phase 3 trials evaluated whether the number of prior anticholinergics used or reason for their discontinuation affected the treatment response to onabotulinumtoxinA 100U in overactive bladder (OAB) patients with urinary incontinence (UI). METHODS: Patients with symptoms of OAB received intradetrusor injections of onabotulinumtoxinA 100U or placebo, sparing the trigone. Change from baseline at week 12 in UI episodes/day, proportion of patients reporting a positive response ('greatly improved' or 'improved') on the treatment benefit scale (TBS), micturition and urgency were evaluated by number of prior anticholinergics (1, 2 or ≥ 3) and reason for their discontinuation (insufficient efficacy or side effects). Adverse events (AE) were assessed. RESULTS: Patients had taken an average of 2.4 anticholinergics before study enrolment. OnabotulinumtoxinA reduced UI episodes/day from baseline vs. placebo, regardless of the number of prior anticholinergics (-2.82 vs. -1.52 for one prior anticholinergic; -2.58 vs. -0.58 for two prior anticholinergics; and -2.92 vs. -0.73 for three or more prior anticholinergics; all p < 0.001). The proportion of TBS responders was higher with onabotulinumtoxinA vs. placebo (69.0% vs. 37.2% for one prior anticholinergic; 58.8% vs. 24.8% for two prior anticholinergics and 56.4% vs. 22.5% for three or more prior anticholinergics; all p < 0.001). Similar results were observed regardless of the reason for discontinuation. OnabotulinumtoxinA reduced the episodes of urgency and frequency of micturition vs. placebo in all groups. AEs were well tolerated, with a comparable incidence in all groups. CONCLUSION: In patients with symptoms of OAB who were inadequately managed by one or more anticholinergics, onabotulinumtoxinA 100U provided significant and similar treatment benefit and safety profile regardless of the number of prior anticholinergics used or reason for inadequate management of OAB. ClinicalTrials.gov: NCT00910845, NCT00910520.

Safety and tolerability of the ß3 -adrenoceptor agonist mirabegron, for the treatment of overactive bladder: results of a prospective pooled analysis of three 12-week randomised Phase III trials and of a 1-year randomised Phase III trial.

AIMS: To evaluate the safety and tolerability of the ß3 -adrenoceptor agonist, mirabegron, in patients with overactive bladder (OAB). METHODS: Tolerability and safety data from three 12-week, randomised, placebo-controlled, double-blind, Phase III trials (Studies 046, 047 and 074) were pooled by treatment group. The three studies were of a similar design, although the assessed doses of mirabegron [25, 50 or 100 mg once daily (qd)] varied, and tolterodine extended release (ER) 4 mg was included as an active-control arm in Study 046 only. Tolerability and safety data from a 1-year, randomised, double-blind, Phase III trial (Study 049) are also presented. Safety variables included the incidence and severity of treatment-emergent adverse events (TEAEs), vital signs and electrocardiogram data. RESULTS: Mirabegron (25, 50 or 100 mg qd) was safe and well-tolerated in patients with OAB over 12-week (n = 2736) and 1-year (n = 1632) periods. The incidence of TEAEs and treatment discontinuations as a result of TEAEs was low; the majority were mild in severity and few were serious. Hypertension, nasopharyngitis and urinary tract infection were the most common TEAEs with mirabegron. The mirabegron tolerability profile was similar to that seen with placebo and tolterodine ER 4 mg, except for dry mouth, which occurred, on average, five times less frequently with mirabegron than tolterodine ER 4 mg. In the pooled 12-week analysis, mirabegron 50 mg was associated with placebo-adjusted mean increases of 0.4-0.6 mmHg in blood pressure and approximately one beat per minute in pulse rate, both reversible upon treatment discontinuation. The incidence of Major Adverse Cardiovascular Events as adjudicated by an independent cardiovascular committee was low and similar across treatment groups. CONCLUSION: The favourable tolerability profile of mirabegron in patients with OAB may allow improved treatment compliance compared with antimuscarinics, with important implications for patient outcomes.

Evidence available on the use of the selective ß3-adrenoceptor agonist mirabegron for the treatment of overactive bladder.

CONTEXT: Mirabegron, the selective ß3-adrenoceptor agonist, heralds the latest development for the treatment of overactive bladder (OAB). OBJECTIVE: To present the evidence available on the efficacy and tolerability of mirabegron and to discuss this treatment's potential in our setting. EVIDENCE ACQUISITION: We reviewed 11 studies conducted with mirabegron in patients with OAB (2 phase II, 9 phase III), all studies were compared to placebo with 6 studies also including tolterodine as an additional arm. Greater emphasis shall be given to the main phase III trials performed in Europe, the USA and Australia evaluating efficacy and safety after 12 weeks (NCT00662909, NCT00689104, NCT00912964) and safety after 12 months (NCT00688688). The combined analyses of these 12 week studies is also available, with emphasis on global efficacy (FAS), efficacy with regard to incontinence (FAS i) and safety (SAF). More than 50% of patients had previously discontinued anticholinergics medication for OAB, thus allowing us to obtain data on the effectiveness of mirabegron in patients already treated with anticholinergics. EVIDENCE SYNTHESIS: Mirabegron is an efficacious drug which presents a statistically significant reduction in the number of incontinence episodes and in urinary frequency as of 4 weeks, with a higher percentage of dry patients and a higher percentage of patients with reduction ≥50% in the number of incontinence episodes than placebo. The efficacy of mirabegron 50 and 100mg in the reduction of incontinence episodes occurs in de novo patients and who have received antimuscarinics, with adjusted mean difference and improvement in urinary frequency greater in treated patients. Its tolerability is very similar to placebo particularly for the adverse effects of the antimuscarinics (dry mouth, constipation and blurred vision). A minimal, non-clinically significant change is observed in systolic and diastolic blood pressure and pulse. Its efficacy is long-term. Mirabegron at the doses of 50 and 100mg presents an improvement versus placebo in patient satisfaction, health-related quality of life (HRQoL), symptom bother and patient's perception of bladder condition (PPBC). In the 12 week Phase III European study tolterodine delivered a lesser degree of improvement than mirabegron versus placebo in patient satisfaction, HRQoL, symptom bother and PPBC. CONCLUSIONS: Mirabegron is the first of a new class of compounds with a novel mechanism of action that is different to the antimuscarinics. It presents significant and clinically important efficacy in the treatment of the symptoms of OAB. It has advantages with regard to the results described by the patient in treatment satisfaction. Studies on its combined use with anticholinergics are ongoing.

Mirabegron for the treatment of overactive bladder: a prespecified pooled efficacy analysis and pooled safety analysis of three randomised, double-blind, placebo-controlled, phase III studies.

INTRODUCTION: To examine pooled efficacy data from three, large phase III studies comparing mirabegron (50 and 100 mg) with placebo, and pooled safety data including additional mirabegron 25 mg and tolterodine extended release (ER) 4 mg results. METHODS: This prespecified pooled analysis of three randomised, double-blind, placebo-controlled, 12-week studies, evaluated efficacy and safety of once-daily mirabegron 25 mg (safety analysis), 50 or 100 mg (efficacy and safety analyses) and tolterodine ER 4 mg (safety analysis) for the treatment of symptoms of overactive bladder (OAB). Co-primary efficacy measures were change from baseline to Final Visit in the mean number of incontinence episodes/24 h and mean number of micturitions/24 h. Key secondary efficacy end-points included mean number of urgency episodes/24 h and mean volume voided/micturitions, while other end-points included patient-reported outcomes according to the Treatment Satisfaction-Visual Analogue Scale (TS-VAS) and responder analyses [dry rate (posttreatment), ≥ 50% reduction in incontinence episodes/24 h, ≤ 8 micturitions/24 h (post hoc analysis)]. The safety analysis included adverse event (AE) reporting, laboratory assessments, ECG, postvoid residual volume and vital signs (blood pressure, pulse rate). RESULTS: Mirabegron (50 and 100 mg once daily) demonstrated statistically significant improvements compared with placebo for the co-primary end-points, key secondary efficacy variables, TS-VAS and responder analyses (all comparisons p < 0.05). Mirabegron is well tolerated and demonstrates a good safety profile. The most common AEs (≥ 3%) included hypertension, nasopharyngitis and urinary tract infection (UTI); the incidence of hypertensive events and UTIs decreased with increasing dose. For mirabegron, the incidence of the bothersome antimuscarinic AE, dry mouth, was at placebo level and of a lesser magnitude than tolterodine. CONCLUSION: The efficacy and safety of mirabegron are demonstrated in this large pooled clinical trial dataset in patients with OAB.

Different surgical approaches for stress urinary incontinence in women.

Stress urinary incontinence (SUI) constitutes involuntary voiding as a consequence of rising intra-abdominal pressure caused by sphincter weakness. In recent years studies were published according to surgical SUI management evaluating and comparing therapy options and outcomes. Therapy options were evaluated using a Medline search, including only publications in English between 2000-2012. Key words used were: SUI, conservative and surgical treatment, midurethral sling, colposuspension. Surgical treatment options demonstrate significantly better results than conservative treatment. MUS demonstrate better subjective and objective cure rates than colposuspension; it is less invasive and more cost-effective. First line SUI therapy such as RP MUS and TVT seem to be favored when compared to transobturator techniques. Retropubic and transobturator MUS showed equivalent objective and subjective success rates. Open colposuspension is an effective treatment possibility for recurrent SUI after failed MUS. TVT, compared with other MUS, seems to show slightly better cure rates. but perioperative complications appear to be similar. Long-term results (>10 years) of repeated SUI surgery showed that the Burch procedure had the lowest 9-year cumulative incidence of repeat SUI surgery. Mini-sling techniques may be underestimated but long-time results are pending and closer monitoring of the adverse event profile must be carried out. MUS are first choice in the treatment of SUI, of which TVT, has the best cure rate. Colpussupension continues to have its place in recurrent SUI. The new mini-MUS needs a longer follow-up for final evaluation.

Validation of treatment benefit scale for assessing subjective outcomes in treatment of overactive bladder.

OBJECTIVES: The assessment of patient-reported treatment benefits is a new efficacy outcome measure in overactive bladder (OAB) clinical trials. We conducted a retrospective psychometric validation of the Treatment Benefit Scale (TBS), a single-item scale used to assess the patient-reported benefits of treatment of OAB. METHODS: The data were collected in the context of 2 large Phase III, randomized, double-blind, placebo-controlled, clinical trials of an antimuscarinic treatment of patients with OAB. Psychometric validation was conducted by examining (a) scale variability, (b) construct validity, (c) divergent validity, (d) known-group validity, and (e) responsiveness of the TBS. RESULTS: The data from 1766 patients were evaluated. The TBS correlated significantly with the expected domains of the King's Health Questionnaire, International Consultation on Incontinence Questionnaire-Short Form, and other patient-reported assessments, providing evidence of construct validity. Divergent validity was supported by a lower correlation between the TBS and unrelated domains of the KHQ. Statistically significant differences in the TBS scores between patients who received active OAB treatment and those receiving placebo provided evidence of known-group validity. Scale responsiveness was demonstrated by effect sizes >0.8. CONCLUSIONS: The TBS demonstrated strong validity and responsiveness for the trial population data, both separately for each trial and pooled. This validation has demonstrated the psychometric properties of the TBS as a patient-reported clinical efficacy outcome measure and suggests that it could provide clinically relevant data for assessing the treatment response among patients in clinical trials of new therapies for OAB.

Multicenter prospective randomized 52-week trial of calcium hydroxylapatite versus bovine dermal collagen for treatment of stress urinary incontinence.

OBJECTIVES: To evaluate the safety and effectiveness of soft-tissue augmentation of the urethral sphincter with calcium hydroxylapatite (CaHA; Coaptite) compared with glutaraldehyde cross-linked bovine collagen (Contigen) in female patients with stress urinary incontinence due to intrinsic sphincter deficiency and without associated urethral hypermobility. METHODS: This 12-month prospective, randomized, comparative, multicenter, single-blind, parallel, clinical trial of CaHA and collagen for soft-tissue augmentation of the urethral sphincter in the treatment of stress urinary incontinence enrolled 296 women. Up to five injections were performed in the first 6 months of the trial. Twelve-month postinjection efficacy data were available for 231 patients. RESULTS: The results indicated that CaHA and collagen were both well tolerated in this study. No systemic adverse events were observed with either product. We used the Stamey Urinary Incontinence Scale to grade the improvement, which was the primary endpoint of the study. At 12 months, 83 (63.4%) of 131 CaHA patients compared with 57 (57.0%) of 100 collagen patients showed improvement of one Stamey grade or more (P = 0.34). More CaHA patients required only one injection (n = 60; 38.0%) during the study compared with the Contigen patients (n = 36; 26.1%; P = 0.034). Also, the average total volume of material injected during the course of the study was less for CaHA than for collagen (4.0 mL versus 6.6 mL, respectively; P <0.0001). CONCLUSIONS: The results of the study have demonstrated that Coaptite is an appropriate and well-tolerated treatment for patients with incontinence due to intrinsic sphincter deficiency. This new soft-tissue augmentation material has a good safety profile and appears to provide durable improvement.

Overactive bladder: achieving a differential diagnosis from other lower urinary tract conditions.

Overactive bladder (OAB) is a debilitating condition characterised by an urgent need to urinate (urgency), often with urinary frequency and, in some cases, urgency incontinence and nocturnal frequency. Patients often adopt complex adaptive behaviours to cope with their symptoms as OAB can compromise all dimensions of a patient's quality of life. Most OAB patients present initially to their primary care physician. Diagnosis is based on presenting symptomatology and does not require any invasive tests. Direct questioning about symptoms is important in achieving a differential diagnosis. The most common condition to be considered when working towards a differential diagnosis is a urinary tract infection (UTI). However, some physicians have expressed concerns about identifying the small number of cases where bladder cancer is a potential underlying aetiology for the symptoms of OAB. In this review, we examine the prevalence and patient profiles for these bladder conditions and their presenting symptomatology. We also review tests that may be recommended to exclude a diagnosis of UTI or bladder cancer and present a diagnostic algorithm suitable for office-based primary care practice.

Prevention and management of incontinence following radical prostatectomy.

Incontinence after radical prostatectomy can have a significant impact on quality of life. Although several risk factors have been identified, the surgical technique and advancing age are important factors associated with postprostatectomy incontinence. Despite advances in technique, incontinence still occurs in a small group of men. Sphincteric dysfunction is the most common cause of postradical prostatectomy incontinence, but bladder dysfunction cannot be discounted. Treatments range from conservative to surgical and should be tailored to the individual based on the degree of bother and patient willingness to accept different therapeutic options.

Post-urethral suspension obstruction.

Urethral obstruction is a consequence of surgery to treat stress incontinence in women. Although its incidence is relatively low, it still presents a challenging problem for the urologist. Recent work has focused on clarifying the etiology and incidence of this condition, as well as providing new definitions on bladder-outlet obstruction in women. In addition, effective, less invasive ways of treating this condition have been described.

Percutaneous afferent neuromodulation for the refractory overactive bladder: results of a multicenter study.

PURPOSE: More than 20 million Americans have an overactive bladder, the predominant symptoms being frequency, urgency, urge incontinence and pelvic pain. While the etiology is not completely understood, most investigators believe the causes to be many and the pelvic floor to be intimately related. Whatever the etiology, traditional therapies, including dietary manipulation, bladder drill, medications and physical therapy, are often poorly tolerated and/or ineffective. We report a prospective, multicenter clinical trial that was undertaken to determine the safety and efficacy of percutaneous peripheral afferent nerve stimulation for treatment of refractive overactive bladder and/or pelvic floor dysfunction. MATERIALS AND METHODS: A total of 53 patients with overactive bladders, in whom all traditional therapy failed, were enrolled in 1 of 5 sites within the United States. Patients received weekly percutaneous electrical stimulations via a 34 gauge needle placed near the tibial nerve 3 finger breadths above the ankle. Urodynamic studies, detailed voiding diaries, quality of life surveys, and incontinence impact questionnaires were completed before, during and after the study. RESULTS: Of the patients with a mean age of 57.4 years 89% (47 of 53) completed the 12-week study. A total of 71% of patients were classified as treatment successes by the investigators and were started on long-term treatment. On average patients noticed a 25% reduction in mean daytime and 21% reduction in mean nighttime voiding frequencies (p <0.05). Urge incontinence was reduced by an average of 35% (p <0.05). Statistically significant improvements were noted in selective pain and quality of life indexes. No significant adverse events related to treatment were noted in any patients. CONCLUSIONS: Percutaneous peripheral afferent nerve stimulation offers a safe, minimally invasive and effective treatment for managing refractive overactive bladder and/or pelvic floor dysfunction.

Dysfunctional voiding in women.

PURPOSE: We characterized presenting symptoms and urodynamic findings in women with dysfunctional voiding. MATERIALS AND METHODS: We reviewed the charts of 26 women diagnosed with dysfunctional voiding. Those with a known or suspected history of neurological disease before evaluation were excluded from study. All patients completed an American Urological Association symptom index, and scores were classified as total, storage (irritative) and emptying (obstructive). The diagnosis of dysfunctional voiding was made on multichannel video urodynamics. There was increased external sphincter activity during voiding. Presenting symptoms and urodynamic findings in all cases were summarized. In addition, symptoms and urodynamic findings in patients later diagnosed with occult neurological disease were compared with those in patients without neurological disease. RESULTS: Mean patient age was 39.2 years (range 19 to 79). Mean total American Urological Association-7 score was 24.4 of 35. Frequency and urgency were the most common presenting symptoms in 82% of cases. Mean storage score was 11.3 of 15 and mean voiding score was 13.2 of 20. Urge and stress incontinence was noted in 6 (23%) and 4 patients (15%), respectively, while 11 (42%) had a history of recurrent urinary tract infection. Cystometrography revealed detrusor instability in 11 cases (42%), sensory urgency in 11 (42%) and impaired compliance in 2 (8%), including 1 with instability. There was great variability in voiding parameters. Mean maximum urinary flow plus or minus standard deviation was 10.4 +/- 6.2 cc per second, mean detrusor pressure at maximum urinary flow was 50.3 +/- 23.5 cm. water and mean post-void residual urine volume was 103.4 +/- 120.0 cc. Video urodynamics prompted neurological evaluation, which revealed occult neurological disease in 5 patients who were then reclassified with external-detrusor sphincter dyssynergia. CONCLUSIONS: Female patients presenting with lower urinary tract symptoms may have dysfunctional voiding patterns. Storage symptoms appear to be even more common than voiding symptoms in this study group. These patients tend to have decreased flow, increased voiding pressure and high post-void residual urine volume. However, there is wide variation in these parameters among individuals. Therefore, careful review of the voiding phase, including pelvic floor electromyography and the fluoroscopic appearance of the bladder outlet, is critical. Occult neurological disease should be suspected in patients with dysfunctional voiding.

The prevalence of urinary incontinence.

Urinary incontinence is a significant health problem with considerable social and economic impact. It is important to distinguish between prevalence and incidence with regard to incontinence, and prevalence-the probability of having incontinence within a defined population at a defined point in time-is the more important when considering its impact and the utilization of healthcare resources. There are large variations in the severity and impact of incontinence, and its severity, frequency, and predictability all need to be considered when evaluating its effects on patients, The degree of bother is particularly significant when determining who will need treatment. Incontinence may be a result of bladder dysfunction, sphincter dysfunction, or a combination of both, but large-scale studies are not designed to determine the etiology. In young women, the prevalence of incontinence is usually low, but prevalence peaks around menopause, with a steady rise there-after into later life. Although the prevalence of stress and mixed (stress and urge) incontinence is higher than urge incontinence, the latter is more likely to require treatment. In women, moderate and severe bother have a prevalence ranging from about 3% to 17%. Severe incontinence has a low prevalence in young women, but rapidly increases at ages 70 through 80. In men, the prevalence of incontinence is much lower than in women, about 3% to 11% overall, with urge incontinence accounting for 40% to 80% of all male patients. Stress incontinence accounts for less than 10% of cases and is attributable to prostate surgery, trauma, or neurological injury. Incontinence in men also increases with age, but severe incontinence in 70- to 80-year-old men is about half of that in women. The most effective therapy for incontinence will rely on targeting the correct populations to be treated, which depends on how data is collected on prevalence and severity.

Bladder outlet obstruction in women: prevalence, recognition, and management.

Bladder outlet obstruction in women is an infrequently diagnosed urological condition. Its prevalence has been estimated to be between 2.7% and 29%. The large variation in prevalence is likely a result of the lack of standard diagnostic definition for the evaluation of female bladder outlet obstruction. A combination of history taking; physical examination; and diagnostic tests, including simple pressure void studies, radiographic imaging, endoscopic visualization, and multichannel videourodynamics provides a consistent way to accurately recognize and diagnose bladder outlet obstruction. Causes of obstruction are varied and numerous but generally fall within two broad categories: functional and anatomic. Treatment options are tailored to individual causes of obstruction and range from conservative pharmacologic and behavioral options to more-invasive surgical procedures.

Value of routine evaluation of the voiding phase when performing urodynamic testing in women with lower urinary tract symptoms.

PURPOSE: Lower urinary tract symptoms in women are often evaluated by cystometrography. We only assessed the bladder response to filling and not the impact of abnormal voiding, which is known to cause lower urinary tract symptoms. We determined the prevalence of voiding abnormalities in women with lower urinary tract symptoms and compared cystometrography to cystometrography plus voiding pressure flow study for evaluating this condition. We also determined whether storage or voiding symptoms predicted abnormal voiding. MATERIALS AND METHODS: We reviewed the records of 134 women who underwent video urodynamics with cystometrography and voiding pressure flow study to evaluate lower urinary tract symptoms. Patients with a history of neurological disease, grade 4 pelvic prolapse or a primary complaint of stress incontinence were excluded from study. All participants completed an American Urological Association symptom index and scores were subclassified as total, storage and voiding. A diagnosis was made in each case based on cystometrography findings, while any additional diagnoses when applicable were based on the voiding pressure flow study. Symptom scores were compared in women in whom the voiding study did and did not add information. RESULTS: Mean patient age was 53.1 years (range 19 to 90). Voiding studies added information in 44 cases (33%), including dysfunctional voiding in 16, obstruction due to a moderate cystocele in 6, primary bladder neck obstruction in 6, external-detrusor sphincter dyssynergia as the initial presentation of neurological disease in 5, obstruction after incontinence surgery in 3, urethral stricture in 3, post-void contraction mimicking symptoms in 2, impaired contractility in 2 and an obstructing urethral diverticulum in 1. A total of 32 patients (24%) did not void during the study. Those with voiding abnormalities had higher total and voiding but similar storage symptom scores (23.1 versus 18.5, 12.3 versus 8.0 and 10.8 versus 10.5 points, p = 0.0008, 0.0001 and 0.58, respectively). CONCLUSIONS: Women with lower urinary tract symptoms may have voiding abnormalities that are missed by cystometrography only. Voiding studies are useful for properly diagnosing and treating such cases. Women with abnormal voiding seem to have more severe voiding symptoms than those without such abnormalities. Occult neurological disease may also be identified in patients with lower urinary tract symptoms and voiding abnormalities.

Erosion of woven polyester pubovaginal sling.

PURPOSE: Various materials have been used for pubovaginal slings to correct female stress urinary incontinence. Use of synthetic materials provides a theoretical advantage in that no graft harvesting is necessary. Major risks of synthetic material use are erosion and infection of the sling. We report on erosion of woven polyester slings treated with pressure injected bovine collagen (ProteGen) which required removal. MATERIALS AND METHODS: Office records of patients who had ProteGen slings removed at 5 centers during the last 24 months were retrospectively reviewed. Presenting symptoms, interval between sling placement and removal, subsequent procedures and continence status following sling removal were evaluated. RESULTS: A total of 34 women required removal of the polyester sling secondary to erosion, infection or pain. The most common presenting complaints were delayed vaginal discharge in 21 patients (62%), vaginal pain or pressure in 21 (62%), suprapubic pain in 11 (32%) and recurrent urinary tract infection in 5 (15%) at a mean of 7.95 months (range 1 to 22) after sling placement. Of the patients 17 (50%) had vaginal erosion only, 7 (20%) isolated urethral erosion and 6 (17%) urethrovaginal fistulas. In 4 patients no erosion was obvious but slings were removed secondary to vaginal pain. Before sling removal 16 patients (47%) were totally dry, 13 (38%) had some degree of urinary incontinence and 3 (8%) had retention. Following sling removal 7 patients (20%) remained dry, 25 (74%) had mild to severe stress urinary incontinence with or without urgency and urge incontinence, and 2 (6%) are pending followup. CONCLUSIONS: Woven polyester slings treated with pressure injected bovine collagen are prone to erosion. Although the ProteGen sling was recalled in January 1999, patients who have had the sling placed must be followed closely.