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Surgical excision is the definitive treatment of urethral diverticulum (UD) and the only reasonable surgical option for treating midurethral and proximal UD. Success depends on proper staging by determining the extent and number of diverticula and attention to surgical technique. This article offers practical guidance in adjusting technique to accommodate commonly encountered difficult clinical scenarios., (Copyright © 2011 Elsevier Inc. All rights reserved.)

Purpose: Treatment options for antimuscarinic refractory neurogenic detrusor overactivity (NDO) are botulinum toxin type A injections (BTX-A) and augmentation cystoplasty (AC). We estimated initial and cumulative 5-year costs of these treatments., Materials and Methods: Base case is an individual with antimuscarinic refractory NDO and decreased bladder compliance. Primary analysis is from the health care payor perspective. Model probabilities and ranges were derived from literature and chart review. Reimbursements were derived from the average of insurance carriers. Complication cost calculations were based on standard practice. Decision-analysis model was made with TreeAge Pro Healthcare 2009 Software, Inc. and rolled back for cost calculation. One-way sensitivity analysis was performed on all variables, and two-way sensitivity analyses were based on these results., Results: Average reimbursement for one BTX-A injection and AC was $2,946.83 and $25,041.53, respectively. BTX-A treatment was less expensive over 5 years, costing $28,065. The model was only sensitive within a reasonable clinical range for Botox durability. BTX-A was more cost-effective over 5 years if the effect lasted for >5.1 months. The model was based on an AC complication rate of 40%. If the PAC complication rate<14%, AC was cheaper over 5 years. The model was sensitive to surgeons costs of BTX-A ($3,027) and facility costs of BTX-A ($1,004) and AC ($17,100)., Conclusions: This is the first cost analysis of BTX-A and AC. BTX-A is cheaper at durations>5.1 months and AC was cheaper when the cost of BTX-A increases or the AC complication rate dropped below 14%.

This article discusses a systematic approach to the repair of cystoceles using interposition grafting. Surgeons' opinions vary regarding which graft is most appropriate as there are several varieties for mesh interposition. High-grade cystocele repair using the porcine dermis interposition graft is successful and associated with few complications. Cystocele repair is typically low grade and does not require additional surgery., (Copyright © 2011 Elsevier Inc. All rights reserved.)

Introduction: Mixed urinary incontinence (MUI) is a prevalent condition and imposes a significant impact on a woman's quality of life. Treatment is often challenging, as a single modality may be inadequate for alleviating both the urge and stress component., Materials and Methods: A MEDLINE search was conducted regarding English-language literature pertaining to the pathophysiology, diagnosis of, and treatment for MUI. Non-English language articles were considered if they could be translated into English using GOOGLE translator., Results: The identification of an ideal single treatment has also been made more challenging by the poor characterization of the pathophysiology of MUI. Behavioral and lifestyle modification, as well as pelvic floor muscle therapy, should be considered first-line options for all women with MUI. Treatment of the urge component with anti-muscarinics is effective; however the stress component is likely to persist after therapy. Anti-incontinence surgery may have a positive impact on both the stress and urge components of MUI, with emerging evidence suggesting that transobturator MUS may be associated with lower rates of de novo and persistent urge component compared to other procedures. The presence of concomitant, preoperative detrusor overactivity has not been consistently associated with postoperative outcomes., Conclusions: The optimum treatment of MUI may often require multiple treatment modalities. While surgery may have a positive impact on both the urge and stress component, its implementation should be approached with caution and patients should be carefully selected. Detailed informed consent in women with MUI cannot be overstated.

Background: Oxybutynin chloride topical gel (OTG; Gelnique®) is an approved formulation for the transdermal administration of oxybutynin, an established antimuscarinic therapy for overactive bladder (OAB). Transdermal administration of oxybutynin minimizes plasma concentrations of the active metabolite N-desethyloxybutynin (N-DEO), which can have anticholinergic adverse effects., Objectives: In four phase I studies, we separately assessed the effects of OTG application site selection on oxybutynin bioavailability (site-to-site study); the effects of post-application showering on oxybutynin steady-state pharmacokinetics (showering study); the effects of sunscreen application on oxybutynin absorption (sunscreen study); and the person-to-person transfer of oxybutynin through skin-to-skin contact at the application site (transference study)., Methods: All four studies were open-label, randomized, phase I studies. The site-to-site and showering studies involved repeated administration of OTG to establish steady-state plasma concentrations of oxybutynin and N-DEO; the other two studies involved single doses. Clinical visits were required for pharmacokinetic sampling, supervision of OTG self-application on pharmacokinetic sampling days, showering, sunscreen application and transference experiments. The study included healthy subjects aged 18-45 years. Subjects with conditions requiring medical therapy or interfering with the application of OTG or the interpretation of pharmacokinetic results were excluded. Participants applied OTG (1 g containing oxybutynin chloride 10%, 1.14 mL/dose) once daily to the abdomen, upper arm/shoulder or thigh. Showering occurred 1-6 hours after dosing. Sunscreen was applied 30 minutes before or after OTG application. Abdomen-to-abdomen contact with movement for 15 minutes between treated and untreated participants was conducted 1 hour after dosing. Time points of serial blood sampling for pharmacokinetic analyses varied among studies. Plasma concentrations of oxybutynin and N-DEO (except transference study) were measured. Bioequivalence was tested with ANOVA models for log(e)-transformed plasma exposure (area under the plasma concentration-time curve [AUC]) and maximum plasma concentration (C(max)) to generate 90% confidence intervals (CIs)., Results: Oxybutynin and N-DEO exposures (AUCs) from time zero to 24 hours (AUC(24)) were similar for the three application sites, with N-DEO/oxybutynin mean AUC(24) ratios of approximately 0.9. The 90% CIs for thigh-to-abdomen ratios of oxybutynin AUC(24) (0.93, 1.23) and C(max) (0.85, 1.16) were within the interval required for bioequivalence (0.8, 1.25); the other application site ratios for oxybutynin had boundaries slightly outside this interval. Showering 1-6 hours and sunscreen application 30 minutes before or after OTG application had minor effects on oxybutynin concentrations. After vigorous skin contact between treated and untreated participants at the application site, the mean ± SD AUC from time zero to 48 hours (AUC(48)) of oxybutynin in 12 untreated participants was 29.8 ± 24.5 ng · h/mL, approximately one-quarter of the exposures generally seen in subjects treated with a single dose of OTG. Oxybutynin AUC(48) after clothing-to-skin contact was undetectable in 12 of 14 untreated participants and very low (mean ± SD 0.4 ± 0.8 ng · h/mL) in two untreated female participants., Conclusion: The bioavailability of oxybutynin and its pharmacokinetic profile are not greatly affected by application site selection, post-application showering or sunscreen use shortly before or after dosing with OTG. Oxybutynin transference to untreated persons is essentially prevented by avoiding direct skin-to-skin contact with the application site.

Overactive bladder (OAB) is a common condition that causes a profound impact on an individual's overall health and quality of life. Muscarinic receptor antagonists are the mainstay of oral pharmacotherapy for OAB. Although all of the medications in this class are significantly more effective than placebo, they are also associated with more adverse events that may limit their overall use. Although newer preparations of these medications have sought to improve tolerability and efficacy through alternative routes of delivery and once-daily dosing, improved adherence to treatment and treatment persistence continue to be an ongoing challenge. An improved understanding of the factors involved in persistence of medical OAB therapy is imperative in efforts to optimize therapeutic benefits in this chronic and potentially morbid condition.

Study Type: Therapy (case series) Level of Evidence 4., Objective: To report the indications and outcomes of a contemporary series of patients with contraindications to percutaneous renal biopsies (PRBs) who had an operative RB (ORB), as although ORB is a relatively infrequent procedure, it remains an important and underreported operation., Patients and Methods: In a retrospective review of patients who had an ORB we examined comorbidities, indications, and 30-day morbidity and mortality. Preoperative comorbidities were stratified according to the Charlson comorbidity index., Results: In all, 115 patients had ORB between 1991 and 2006 (mean age 48 years, range 18-83); 60% of the patients were American Society of Anesthesiologists class >or=3. The median Charlson comorbidity index score was 3, with a score of 0 in 20.9%, 1-2 in 27.8%, 3-4 in 30.4% and >or=5 in 20.9% of patients. Indications for an ORB included morbid obesity, failed PRB, coagulopathy, and solitary kidney. In all, 47.8% of patients had a serum creatinine level of <3.0 mg/dL, 34.8% of >3.0 mg/dL and 17.4% were dialysis-dependent. There were 43 complications in 36 patients. The mortality rate after surgery was 0.8%. There were eight major complications in seven patients (6.1%) including cardiac arrest, stroke, sepsis, reoperation and re-intubation. There were minor complications 34 times in 31 patients (27%), the most common being wound infection, pneumonia, intraoperative transfusion of >2 units, arrhythmia, postoperative retroperitoneal bleed, and seep vein thrombosis., Conclusions: This study shows that there are significant comorbidities in patients referred to urologists for an ORB. With a mortality rate of 0.8% and major and minor complication rates of 6.1% and 27%, respectively, the ORB, while infrequent, carries a significant risk in this population that should be included in preoperative decision making and used for patient counselling.

Lower urinary tract symptoms (LUTS) are common and increase with age in men with benign prostatic hypertrophy (BPH). Erectile dysfunction (ED) also increases with age and is often a comorbid condition with BPH. Treatment with phosphodiesterase type 5 (PDE5) inhibitors aimed at decreasing breakdown of nitric oxide (NO) is a mainstay of treatment for ED. Because NO has been found to mediate male prostatic and urinary function in multiple ways, there is increasing interest in PDE5 inhibitors addressing concomitant LUTS. Several studies have shown significant improvement in LUTS after treatment with PDE5 inhibitors; however, concern exists that PDE5 inhibitors exert their beneficial effects through impairment of bladder function. Because limited invasive urodynamic data exist to address these queries, tadalafil's impact on bladder function was recently evaluated. Results indicate that tadalafil treatment had no negative impact on bladder function, as measured by detrusor pressure at maximum flow or any other urodynamic parameter assessed.

Purpose: Patient complaints are associated with physician risk management experience, including medical malpractice claims risk, and small proportions of physicians account for disproportionate shares of claims. We investigated whether patient complaint experience differs among urologists, and whether urological subspecialists generate distinct quantities and types of complaints., Materials and Methods: This retrospective study examined 1,516 unsolicited patient complaints filed against 268 urologists. Patient complaint and urological subspecialty data were collected from January 1, 2004 through December 31, 2007 for 15 geographically diverse health systems. The cohort urologists were assigned medical malpractice claims risk scores and complaint type profiles. A weighted sum algorithm produced risk scores from 4 consecutive years of complaint data and complaint type profiles were generated using a standardized coding system. Statistical analyses tested the associations among risk score, complaint type profile and urological subspecialty. Complaint type profile and subspecialty distribution were assessed for urologists in the cohort top decile for risk scores., Results: Overall 125 (47%) urologists were associated with 0 patient complaints, while 30 (11%) urologists were associated with 758 (50%) of the patient complaints. Subspecialty and distribution of risk scores were significantly associated (p <0.001). Calculi and oncology subspecialist distributions suggest greater overall risk. Complaint types also varied among subspecialists (p = 0.02). There was no association between top decile urologists and complaint type profile (p = 0.19)., Conclusions: Unsolicited patient complaints were nonrandomly distributed among urologists and urological subspecialties. Monitoring patient complaints may allow for early identification of and intervention with high risk urologists before malpractice claims accumulate., (2010 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Purpose: We updated the 1997 American Urological Association guideline on female stress incontinence., Materials and Methods: MEDLINE searches of English language publications from 1994 and new searches of the literature published between December 2002 and June 2005 were performed using identified MeSH terms. Articles were selected for the index patient defined as the otherwise healthy woman who elected to undergo surgery to correct stress urinary incontinence or the otherwise healthy woman with incontinence and prolapse who elected to undergo treatment for both conditions., Results: A total of 436 articles were identified as suitable for inclusion in the meta-analysis, and an additional 155 articles were suitable for complications data only due to insufficient followup of efficacy outcomes in the latter reports. Surgical efficacy was defined using outcomes pre-specified in the primary evidence articles. Urgency (resolution and de novo) was included as an efficacy outcome due to its significant impact on quality of life. The primary efficacy outcome was resolution of stress incontinence measured as completely dry (cured/dry) or improved (cured/improved). Complications were analyzed similarly to the efficacy outcomes. Subjective complications (pain, sexual dysfunction and voiding dysfunction) were also included as a separate category., Conclusions: The surgical management of stress urinary incontinence with or without combined prolapse treatment continues to evolve. New technologies have emerged which have impacted surgical treatment algorithms. Cystoscopy has been added as a standard component of the procedure during surgical implantation of slings., (2010 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Objectives: Overactive bladder syndrome (OAB) is a urinary condition that often exerts detrimental effects on an individual's quality of life (QoL). A once-daily, extended-release (ER) formulation of the quaternary amine trospium chloride has recently been developed for the treatment of OAB. The pooled health-related QoL (HRQoL) data from two multicenter, parallel-group, double-blind Phase III studies with trospium chloride ER 60 mg were analyzed., Methods: Subjects aged>or=18 years with urinary urgency, frequency, and an average of >or=1 urge urinary incontinence episode per day on a 3-day bladder diary were randomized (1:1) to receive once-daily trospium 60 mg ER or placebo for 12 weeks. HRQoL was assessed at baseline and at Week 12 using the King's Health Questionnaire (KHQ) and the OAB questionnaire (OAB-q)., Results: Overall, 1165 subjects were randomized (trospium ER, n=578; placebo, n=587). Trospium ER produced significantly greater improvements from baseline than placebo in seven of the nine KHQ domains. At Week 12, the improvement in mean OAB-q HRQoL total score (from approximately 52 at baseline) was significantly greater with trospium ER than with placebo (+25.8 vs. +20.7; P=0.0003). Improvements from baseline were seen with trospium ER on all eight of the OAB-q symptom bother scales., Conclusions: Once-daily trospium 60 mg ER improved the QoL of subjects with OAB, as assessed using the KHQ and the OAB-q, in two large Phase III clinical trials.

Overactive bladder (OAB) is a common condition that causes a profound impact on an individual's overall health and quality of life. Muscarinic antagonists are the mainstay of oral pharmacotherapy for OAB. The most-recently introduced muscarinic antagonist, fesoterodine fumarate, is unique in that the parent compound has no antimuscarinic efficacy due to its rapid and complete hydrolysis after oral administration. The active metabolite, 5-hydroxymethyl tolterodine, is responsible for all of the antimuscarinic effects. In two phase III studies, fesoterodine has been shown to significantly reduce mean urgency and urge urinary incontinence (UUI) episodes over placebo. As many as 60% of patients actively treated with fesoterodine reported no urge urinary incontinence episodes on a 3-day voiding diary, a significant improvement over placebo. Finally, several quality of life indices were significantly improved over placebo. There was a dose-related increase in antimuscarinic adverse events, such as dry mouth and constipation; however, few patients discontinued fesoterodine due to side effects., (Copyright 2010 Prous Science, S.A.U. or its licensors. All rights reserved.)

Objectives: To evaluate the efficacy and tolerability of flexible-dose fesoterodine vs placebo in subjects with overactive bladder (OAB)., Methods: In a 12-week double-blind trial, subjects were randomized to fesoterodine 4 mg or placebo once daily, taken within 4 hours of bedtime. At week 2, subjects could increase the fesoterodine dose to 8 mg (sham escalation for placebo). Subjects completed 3-day bladder diaries, Patient Perception of Bladder Condition, and Urgency Perception Scale at baseline and weeks 2, 6, and 12 as well as OAB Questionnaire at baseline and week 12., Results: Of 883 subjects, 63% and 73% of the fesoterodine (n = 438) and placebo (n = 445) groups, respectively, opted for dose escalation. Week 12 improvements from baseline in total micturitions, urgency episodes, urgency urinary incontinence episodes, frequency-urgency sum, and all OAB Questionnaire scales and domains, but not nocturnal micturitions or nocturnal urgency episodes, were significantly greater with fesoterodine than placebo (all P <.05). Treatment differences in micturitions and frequency-urgency sum were significant by week 2 and in urgency urinary incontinence and urgency episodes by week 6. Significantly greater percentages of subjects taking fesoterodine had improved Patient Perception of Bladder Condition and Urgency Perception Scale scores at weeks 2, 6, and 12 (P <.05). Dry mouth (fesoterodine, 26%; placebo, 8%) and constipation (fesoterodine, 11%; placebo, 6%) were the most common adverse events. In both groups, 87% of the subjects completed the trial; 8% and 5% of the fesoterodine and placebo groups, respectively, discontinued because of an adverse event., Conclusions: Flexible-dose fesoterodine was efficacious and generally well tolerated for treatment of OAB symptoms., (2010 Elsevier Inc. All rights reserved.)

Introduction and Hypothesis: To confirm the efficacy and tolerability of extended release (ER) trospium chloride in women with overactive bladder syndrome (OAB), data from two identical phase III studies were analyzed., Methods: Adults (aged > or = 18 years) who had OAB with urinary urgency, frequency, and urge urinary incontinence (UUI) were randomized to trospium ER 60 mg or placebo once daily for 12 weeks. The analysis included 989 women (trospium ER, n = 484; placebo, n = 505). Endpoints examined included changes from baseline in number of toilet voids and UUI episodes/day at week 12. Continuous data were analyzed using rank analysis of variance., Results: At week 12, significantly greater mean reductions in numbers of toilet voids and UUI episodes/day occurred with trospium ER versus placebo (P < 0.0001). Adverse events considered at least possibly related to treatment with trospium ER included dry mouth (11.4%) and constipation (8.9%)., Conclusions: Trospium ER was effective and well tolerated in women with OAB.

Introduction: The study of urinary urgency is challenging for a number of reasons, including our lack of understanding of the normal physiology of urinary sensation and the pathophysiology of abnormal sensation. Issues with nomenclature and lack of agreement about the nature of the experience of normal and abnormal urinary sensation add to this difficulty., Materials and Methods: Review of published literature and critique., Results: Currently available tools for measurement of urgency include validated questionnaires that describe the severity of urgency and its impact on quality of life, modified bladder diaries, body maps of urgency, and measures of urinary sensation during filling cystometry. All these provide some information about the experience of urinary urgency, but no single measure currently captures its multidimensional nature., Conclusions: Measurement of urgency in clinical practice and indeed the optimal treatment strategy has yet to come of age.

Background: Trospium chloride is an antimuscarinic agent with a hydrophilic polar quaternary amine structure that is minimally metabolised by hepatic cytochrome P450 and is actively excreted in the urine, each of which confers a potential benefit with regard to efficacy and tolerability., Purpose: We analysed pooled data from two identically designed phase III trials of a once-daily, extended-release (XR) formulation of trospium chloride (trospium XR 60-mg capsules) in subjects with overactive bladder syndrome (OAB)., Methods: Adults with OAB of > or = 6 months' duration with urinary urgency, frequency and > or = 1 urge urinary incontinence (UUI) episode/day were enrolled in these multicentre, parallel-group, double-blind trials. Participants were randomised (1 : 1) to receive trospium XR 60 mg or placebo for 12 weeks. Primary efficacy variables were changes in urinary frequency and the number of UUI episodes/day. Adverse events (AEs) were recorded throughout., Results: In total, 1165 subjects were randomised (trospium XR, 578; placebo, 587). At baseline, subjects averaged 12.8 toilet voids/day and 4.1 UUI episodes/day. Compared with placebo, subjects treated with trospium XR had significantly greater reductions from baseline in the mean number of toilet voids/day (-1.9 vs. -2.7; p < 0.001) and UUI episodes/day (-1.8 vs. -2.4; p < 0.001) at week 12. The most frequent AEs considered possibly related to study treatment were dry mouth (trospium XR, 10.7%; placebo, 3.7%) and constipation (trospium XR, 8.5%; placebo, 1.5%). Notably, rates of central nervous system (CNS) AEs were lower with trospium XR vs. placebo (dizziness: 0.2% vs. 1.0%; headache: 1.4% vs. 2.4%)., Conclusions: Treatment with trospium XR resulted in statistically significant improvements in both of the dual primary and all of the secondary outcome variables. Trospium XR demonstrated favourable rates of AEs, particularly CNS AEs (numerically lower than with placebo) and dry mouth (lower than previously reported with trospium immediate-release, although not compared in a head-to-head study).

Background: Treatment options for overactive bladder (OAB) with urinary urge incontinence (UUI) refractory to oral antimuscarinics include: botulinum toxin type A (BoNTA), sacral neuromodulation (SNM), and augmentation cystoplasty (AC). A standard treatment success metric that can be used in both clinical and economic evaluations of the above interventions has not emerged. Our objective was to conduct a literature review and synthesis of published measures of treatment success for OAB with UUI interventions and to identify a treatment success outcome., Methods: We performed a literature review of primary studies that used a definition of treatment success in the OAB with UUI population receiving BoNTA, SNM, or AC. The recommended success outcome was compared to generic and disease-specific health-related quality-of-life (HRQoL) measures using data from a BoNTA treatment study of neurogenic incontinent patients., Results: Across all interventions, success outcomes included: complete continence (n = 23, 44%), > or = 50% improvement in incontinence episodes (n = 16, 31%), and subjective improvement (n = 13, 25%). We recommend the OAB with UUI treatment success outcome of > or = 50% improvement in incontinence episodes from baseline. Using data from a neurogenic BoNTA treatment study, the average change in the Incontinence Quality of Life questionnaire was 8.8 (95% CI: -4.7, 22.3) higher for those that succeeded (N = 25) versus those that failed (N = 26). The average change in the SF-6D preference score was 0.07 (95% CI: 0.02, 0.12) higher for those that succeeded versus those that failed., Conclusion: A treatment success definition that encompasses the many components of underlying OAB with UUI symptoms is currently not practical as a consequence of difficulties in measuring urgency. The treatment success outcome of > or = 50% improvement in incontinence episodes was associated with a clinically meaningful improvement in disease-specific HRQoL for those with neurogenic OAB with UUI. The recommended success definition is less restrictive than a measure such as complete continence but includes patients who are satisfied with treatment and experience meaningful improvement in symptoms. A standardized measure of treatment success will be useful in clinical and health economic applications.

Context: The focus of clinical understanding and management of male storage lower urinary tract symptoms (LUTS) has shifted from the prostate to the bladder. This is mirrored by an increasing body of experimental evidence suggesting that the bladder is the central organ in the pathogenesis of LUTS., Objective: A systematic review of the literature available on pathophysiologic aspects of storage LUTS., Evidence Acquisition: Medline was searched for the period ending December 2008 for studies on human and animal tissue exploring possible functional and structural alterations underlying bladder dysfunction. Further studies were chosen on the basis of manual searches of reference lists and review papers., Evidence Synthesis: Numerous recent publications on LUTS pathophysiology were identified. They were grouped into studies exploring abnormalities on urothelial/suburothelial, muscular, or central levels., Conclusions: Studies revealed both structural and functional alterations in bladders from patients with LUTS symptoms or animals with experimentally induced bladder dysfunction. In particular, the urothelium and the suburothelial space, containing afferent nerve fibres and interstitial cells, have been found to form a functional unit that is essential in the process of bladder function. Various imbalances within this suburothelial complex have been identified as significant contributors to the generation of storage LUTS, along with potential abnormalities of central function.

The prevalence of overactive bladder (OAB) symptoms is considerable in both men and women and the impact on quality of life (QOL) is equally substantial. Ironically, despite nearly equal prevalence, OAB symptoms in men are infrequently treated, and often with medical therapies aimed at bladder outlet obstruction (BOO). In this review, we examine the pathophysiology of OAB and its evaluation in the context of benign prostatic hypertrophy and concomitant BOO. We then consider the efficacy and safety of individual therapeutic options for lower urinary tract symptoms in men, focusing on the mainstays of medical therapy: α-adrenergic blockers, 5-α reductase inhibitors, and antimuscarinic agents. Finally, we aim to comment on new therapeutic strategies and targets that may one day be available for the treatment of male OAB.

Purpose: We reviewed cases of genitourinary fistula resulting from birth trauma in Sierra Leone to determine factors predictive of successful operative repair., Materials and Methods: A total of 505 operative repairs of genitourinary fistula were completed at 2 centers in Sierra Leone from 2004 to 2006. Statistical analysis of patient demographics, fistula characteristics, outcomes and surgical complications was performed., Results: Primary repairs, defined as the first repair, accounted for 68% of repairs in the population with 92% classified as vesicovaginal fistula alone. Only 56% of women were deemed to have an intact urethra at presentation and 68% were diagnosed with moderate or severe fibrosis surrounding the fistula. On univariate analysis parameters that demonstrated significant differences with primary operative success were patient age at fistula occurrence (p = 0.0192), index pregnancy (p = 0.0061), location (p <0.0001), surface area (p <0.0001), urethral status (p <0.0001) and fibrosis (p <0.0001). On multivariate analysis the fistula parameter that correlated with successful repair was the extent of fibrosis (severe fibrosis OR 3.7)., Conclusions: Genitourinary fistula as a result of prolonged obstructed labor is a cause of considerable morbidity in sub-Saharan Africa, including Sierra Leone. The most profound factor correlating with a positive operative outcome was the extent of fibrosis surrounding the fistula. These data are important to help predict the likelihood of successful repair and assist in selecting women for the appropriate surgical procedure.

Purpose: We assessed the efficacy and safety of oxybutynin chloride topical gel vs placebo in adults with overactive bladder., Materials and Methods: Men and women 18 years or older with urge predominant urinary incontinence were enrolled in randomized, parallel group, double-blind, placebo controlled Study OG05009 done at 76 clinics in the United States. Eligible patients were assigned to receive 1 gm oxybutynin chloride topical gel (10% weight per weight ethanol based formulation of oxybutynin) or matching placebo once daily for 12 weeks. Efficacy was assessed using data from 3-day urinary diaries and the primary outcome was the change from baseline in the number of urge incontinence episodes. Safety was monitored through adverse event reporting. Efficacy results in the oxybutynin chloride topical gel and placebo groups were compared by ANCOVA with last observations carried forward., Results: A total of 789 randomized patients, including 704 women (89.2%), with a mean age of 59 years were assigned to treatment with oxybutynin chloride topical gel (389) or placebo (400). The mean number of urge incontinence episodes decreased significantly more in patients treated with oxybutynin chloride topical gel than in those given placebo (-3.0 vs -2.5 per day, p <0.0001). Mean urinary frequency decreased (-2.7 per day, p = 0.0017) and voided volume increased (21.0 ml, p = 0.0018) significantly more in the oxybutynin chloride group than in the placebo group (-2.0 per day and 3.8 ml, respectively). Treatment related dry mouth was more frequent in the oxybutynin chloride group than in the placebo group (27 of 389 patients or 6.9% vs 11 of 400 or 2.8%). Application site reactions were infrequently observed in the oxybutynin chloride and placebo groups (21 of 389 patients or 5.4% and 4 of 400 or 1.0%, respectively). No serious treatment related adverse events occurred., Conclusions: Oxybutynin chloride topical gel was efficacious in improving overactive bladder symptoms and was well tolerated in adult patients.

Context: The term "lower urinary tract symptoms" (LUTS) was introduced to dissociate male urinary symptoms from any implied site of symptom origin, such as the prostate., Objective: To consider a more expansive view of LUTS, moving beyond an organocentric focus., Evidence Acquisition: Review of the available literature by a consensus panel., Evidence Synthesis: A consensus group reviewed the literature and developed a conceptual framework to facilitate research and clinical practice in patients with LUTS, following steps outlined in the Delphi procedure. Committee discussion, with presentations and review of existing literature and knowledge at four separate occasions, and extensive review and discussion of draft documents encapsulating group views followed. Consensus group findings included evidence that LUTS increase with age and are prevalent in both male and female patients, with differences in the prevalence of individual storage, voiding, and postmicturition symptoms representing underlying pathophysiologic factors between the sexes. Additionally, it was recognised that patients often have underlying and overlapping pathophysiologic mechanisms that may be related to the expression of LUTS and that this global approach to LUTS reflects our contemporary recognition of the lower urinary tract as an integrated functional unit. To improve the current management of patients, education and awareness regarding LUTS, its causes, and associated comorbidities are needed. Major limitations of this work are the potential interpretive bias introduced by prior perceptions and the nature of the study populations drawn conventionally from secondary care., Conclusions: In conclusion, it is misleading to attribute individual symptoms to sex differences or to a specific underlying organ. LUTS are a non-sex-specific, non-organ-specific group of symptoms, which are sometimes age-related and progressive. A need exists to increase education and awareness regarding LUTS, its causes, and associated comorbidities, and to assess and treat men and women for all LUTS, not just selected symptoms.

Polypropylene midurethral slings have become the most common surgical procedure for the treatment of stress urinary incontinence. The efficacy has been well established through prospective and systematic evaluation. Transobturator midurethral slings have demonstrated comparable efficacy relative to the retropubic approach with the potential to minimize the morbidity associated with retropubic needle passage. We present a case of recalcitrant medial thigh pain after transobturator midurethral sling placement that ultimately required medial thigh/transobturator exploration and sling excision.

Purpose of Review: Bladder outlet obstruction in women results from a remarkable diversity of underlying pathologies. The potential array of presenting symptoms often makes the diagnosis complex, although the condition is predominantly assessed by the urologist as a consequence of incontinence surgery. Recent advances in the diagnosis and management of outlet obstruction in women and the impact on clinical practice are outlined. Recent trials have defined the importance of early intervention for successful resolution of acute, surgically induced obstruction in women. Methods of management for persistent symptoms due to induced obstruction have been reported that render improved symptomatic response., Recent Findings: We present strategies for diagnostic evaluation of bladder outlet obstruction, including history taking and physical exam, as well as a review of appropriate imaging modalities and utilization of videourodynamics. Common conditions resulting in bladder outlet obstruction are discussed along with disease-specific treatment strategies. Diagnostic definitions of obstruction have evolved and improved nomograms have been developed to define study populations., Summary: Recent data have underscored the need for a structured management algorithm. Areas of future research should focus on understanding the natural history of outlet obstruction in women, especially when it occurs in women who have undergone surgery for incontinence and have developed obstruction. Lower urinary tract response to acute obstruction and method of optimal management remain to be defined.

Objectives: Little is known about the host response to the various biologic and synthetic graft materials used as substitutes for autologous fascia. We investigated the host response to sling graft materials in humans., Methods: A total of 24 women undergoing sling revision had a portion of the graft material removed for comparative analysis. At exploration, the degree of graft preservation (integrity), encapsulation, infection, and fibrosis was quantified. A histopathologic analysis was performed by systematically examining each specimen for the inflammatory response, neovascularity, and host fibroblast infiltration., Results: A total of 24 grafts were explanted at 2-34 months after implantation. The indications for removal were a lack of sling efficacy in 2, urinary retention in 9, and sling obstruction in 13. The types of graft material were polypropylene mesh (PPM) in 10, autologous fascia in 5, porcine dermis in 4, cadaveric dermis in 3, and cadaveric fascia in 2. No graft degradation had occurred in PPM material. Autologous and cadaveric fascia had the most demonstrable graft degradation. No encapsulation had occurred with autologous fascia or PPM. The porcine dermis was the most encapsulated. No host infiltration had occurred with the encapsulated porcine grafts, and only peripheral infiltration of fibroblasts had occurred in the cadaveric grafts. The PPM grafts had the greatest number of fibroblasts throughout the entire graft. Neovascularity was the most prevalent in mesh and was also present in the autologous fascia. Giant cells were seen in two mesh and two porcine grafts., Conclusions: The results of our study have shown that porcine dermis has the potential to encapsulate. The degree of host tissue infiltration was greatest with PPM, and no degradation of the mesh material had occurred with time.

Purpose: Nicotinic afferent pathways may be involved in the regulation of bladder inflammation. Based on that hypothesis we investigated the role of nicotinic signaling in a comparative analysis of 2 models of experimental bladder inflammation using protamine sulfate and cyclophosphamide., Materials and Methods: Protamine sulfate and cyclophosphamide were used to induce acute bladder inflammation. Nicotinic agonists and antagonists were given concomitant to the bladder inflammatory agents. Changes in bladder inflammation were measured histologically by a pathologist and through the expression of inflammatory genes., Results: Histologically cyclophosphamide induced more inflammatory changes than protamine sulfate during acute bladder inflammation. Antagonizing nicotinic signaling with mecamylamine induced further inflammatory changes on histology when used with cyclophosphamide but not with protamine sulfate. However, antagonizing nicotinic signaling in combination with protamine sulfate induced greater increases in mRNA expression of the inflammatory cytokine interleukin-6 compared to cyclophosphamide and mecamylamine combination treatments. The activation of nicotinic signaling attenuated acute bladder inflammation by protamine sulfate and cyclophosphamide independently through the down-regulation of increased interleukin-6 expression., Conclusions: Acutely cyclophosphamide treatment results in a greater frank bladder inflammation model in mice than protamine sulfate. However, cholinergic signaling can inhibit inflammation by either mechanism of induced bladder injury. Interleukin-6 gene expression is present and it can be regulated by afferent neuronal signaling even in the absence of observed histological changes in acute bladder inflammatory models.

Purpose: Antimicrobial prophylaxis is the periprocedural systemic administration of an antimicrobial agent intended to reduce the risk of postprocedural local and systemic infections. The AUA convened a BPP Panel to formulate recommendations on the use of antimicrobial prophylaxis during urologic surgery., Materials and Methods: Recommendations are based on a review of the literature and the Panel members' expert opinions., Results: The potential benefit of antimicrobial prophylaxis is determined by patient factors, procedure factors, and the potential morbidity of infection. Antimicrobial prophylaxis is recommended only when the potential benefit outweighs the risks and anticipated costs (including expense of agent and administration, risk of allergic reactions or other adverse effects, and induction of bacterial resistance). The prophylactic agent should be effective against organisms characteristic of the operative site. Cost, convenience, and safety of the agent also should be considered. The duration of antimicrobial prophylaxis should extend throughout the period when bacterial invasion is facilitated and/or likely to establish an infection. Prophylaxis should begin within 60 minutes of the surgical incision (120 minutes for intravenous fluoroquinolines and vancomycin) and generally should be discontinued within 24 hours. The AHA no longer recommends antimicrobial prophylaxis for genitourinary surgery solely to prevent infectious endocarditis. Justifications and recommendations for specific antimicrobial prophylactic regimens for specific categories of urologic procedures are provided., Conclusions: The recommendations provided in this document, including specific indications and agents enumerated in the Tables, can assist urologists in the appropriate use of periprocedural antimicrobial prophylaxis.

Purpose: Bladder outlet obstruction following stress incontinence surgery may present as a spectrum of lower urinary tract symptoms. We evaluated the prevalence and impact of persistent overactive bladder symptoms following urethrolysis for iatrogenic bladder outlet obstruction., Materials and Methods: In a retrospective review we identified 40 patients who underwent urethrolysis. All patients underwent a standardized urological evaluation. Patients identified with genitourinary erosion, neurogenic bladder dysfunction and preexisting overactive bladder were excluded. Urethrolysis outcomes were determined by subjective bladder symptoms and objective parameters. Validated questionnaires were completed to assess symptom bother, patient satisfaction and quality of life. Statistical analyses were performed using Stata, version 9.0., Results: A total of 40 patients were included in the study with a mean +/- SD followup of 13 +/- 11 months (range 3 to 38). Of the patients 34 patients presented with obstructive symptoms, while 36 had overactive bladder symptoms. Obstructive symptoms resolved in 28 of the 34 patients (82%), while overactive bladder symptoms resolved completely in only 12 (35%) and they were significantly improved in 4 (12%). Overall 20 patients (56%) were on antimuscarinics for refractory overactive bladder and 8 ultimately required sacral neuromodulation. Pre-urethrolysis detrusor overactivity was more likely in patients with persistent overactive bladder symptoms than in those in whom overactive bladder symptoms resolved (70% vs 38%). Patients with persistent overactive bladder had significantly greater symptom severity/bother, and decreased perception of improvement and quality of life following urethrolysis., Conclusions: Following urethrolysis overactive bladder symptoms may remain refractory in 50% or greater of patients, which has a negative impact on quality of life and the impression of improvement after surgery. Detrusor overactivity demonstrated preoperatively may be useful for predicting who may have persistent overactive bladder symptoms despite an effective urethrolysis procedure.

Objectives: A once-daily (QD) formulation of trospium chloride has been developed for the management of overactive bladder syndrome (OAB). This randomized controlled trial evaluated the efficacy and tolerability of this new extended-release formulation, trospium chloride 60 mg QD., Methods: Adults with OAB with urinary urgency, frequency, and urgency urinary incontinence (UUI) were eligible for inclusion. Subjects received trospium 60 mg QD or placebo for 12 weeks. Change in the mean number of toilet voids per day and UUI episodes per day were the primary outcome variables. Changes in urgency severity were also assessed and adverse events (AEs) were recorded., Results: Overall, 564 subjects participated in the study (trospium QD 280; placebo 284). Trospium QD demonstrated significant improvement in both primary outcome variables. The mean number of toilet voids per day was reduced from approximately 13 at baseline to 10.3 for trospium QD versus 11.1 for placebo (P <0.001) at week 12, whereas the number of UUI episodes per day was reduced from approximately 4 at baseline to 1.7 at week 12 with trospium QD versus 2.4 for placebo (P <0.001). Trospium QD also reduced urgency severity (P <0.001) and increased voided volume (P <0.01) compared with placebo. Benefits over placebo were apparent within the first week of treatment. Trospium QD was well tolerated; the most frequent AEs being dry mouth (trospium QD 12.9%; placebo 4.6%) and constipation (7.5% versus 1.8%, respectively). Central nervous system side effects were rarely observed and were comparable between groups., Conclusions: Trospium QD represents a convenient, effective, and well-tolerated treatment option for OAB.

Refractory overactive bladder (OAB) after urethrolysis for iatrogenic bladder outlet obstruction (BOO) is a clinical dilemma without established guidelines for management. We sought to evaluate the efficacy of sacral neuromodulation (SNM) in the management of this complex patient population. Retrospective review identified eight patients who underwent SNM secondary to refractory OAB after urethrolysis or sling take-down. SNM was performed with the Interstim device (Medtronic, Minneapolis) using a two-stage implant technique. SNM outcomes were determined subjectively during follow-up. Validated questionnaires were completed to assess symptom bother, patient satisfaction, and quality of life. Statistical analyses were conducted using Stata version 9.0. Six patients had a favorable response to SNM during test stimulation and underwent implantation of the implantable pulse generator (IPG). With follow-up of 15.7 +/- 11.1 months (6-34), all patients significantly improved, with three patients being dry and three patients having one to two urgency incontinence episodes per week. Patient-reported outcomes indicated that patients perceived themselves as very much improved (3) or much improved (3) after SNM, while those failing test stimulation perceived no change. Quality of life and symptom bother were significantly better in SNM responders vs nonresponders. SNM appears to be an effective and viable treatment option in this complex patient population. Further work is needed to determine clinical factors predictive of outcome and durability of response.

Inflammation is a physiological process that characterizes many bladder diseases. We hypothesized that nicotinic and estrogen signaling could down-regulate bladder inflammation. Cyclophosphamide was used to induce acute and chronic bladder inflammation. Changes in bladder inflammation were measured histologically and by inflammatory gene expression. Antagonizing nicotinic signaling with mecamylamine further aggravated acute and chronic inflammatory changes resulting from cyclophosphamide treatment. Estrogen and nicotinic signaling independently attenuated acute bladder inflammation by decreasing neutrophil recruitment and down-regulating elevated lipocalin-2 and cathepsin D expression. However, the combined signaling by the estrogen and nicotinic pathways, as measured by macrophage infiltration and up-regulation of interleukin-6 expression in the bladder, synergistically reduced chronic bladder inflammation. The elevated expression of p65 nuclear localization in bladders treated with cyclophosphamide or cyclophosphamide with mecamylamine suggested nuclear factor-kappa B activation in the chronic inflammatory process. The complementary treatment of 17 beta-estradiol and the nicotinic agonist anabasine resulted in the translocation of p65 to the cytoplasm, again greater than either alone. Activation of nuclear factor-kappaB can result in macrophage activation and/or elevation in epithelial proliferation. These data suggest that 17 beta-estradiol and anabasine reduce chronic bladder inflammation through reduction of nuclear translocation of p65 to suppress cytokine expression.

Overactive bladder (OAB) is a highly prevalent urinary condition with a profound affect on quality of life. Urinary urgency is the cornerstone symptom that defines OAB and drives all subsequent OAB symptoms. The clinical assessment and measurement of urgency has been limited by its definition, limited understanding of well-defined pathophysiology, and psychometric measurement properties. This review outlines the important issues relevant to the clinical assessment and measurement scales commonly used to evaluate and measure urinary urgency. This will have important implications toward further understanding and advancing the field of overactive bladder., (Copyright 2007 Wiley-Liss, Inc.)

Purpose: We evaluated the performance and complications of currently available synthetic sling materials with a focus on in vitro and in vivo biocompatibility, and acceptance in the human body., Materials and Methods: We reviewed the MEDLINE database for relevant literature pertaining to various synthetic sling materials. The Food and Drug Administration regulations regarding the regulation and biocompatibility testing of synthetic meshes were also reviewed., Results: Many synthetic meshes used for sling construction were introduced before rigorous Food and Drug Administration regulations were passed and, thus, some became associated with unique complications. Most meshes used in pubovaginal and mid urethral sling surgery are associated with high short-term success rates and relatively few intraoperative complications. Despite modifications and additives, slings constructed from polytetrafluoroethylene and polyethylene are poorly accepted by the human body. Flexible, macroporous, polypropylene meshes appear to integrate more completely with human tissue than other synthetic materials. However, multifilament and nonknitted polypropylene slings may integrate poorly., Conclusions: The composition, weave and pore size of each material are unique. These properties are responsible for the strength and durability of the material, as well as the ultimate acceptance and incorporation in the human body. Each material should be individually evaluated and patients should be counseled appropriately before implantation.

Purpose: In conjunction with the assignment to update the Guidelines for Management of Clinically Localized Prostate Cancer, the American Urological Association Prostate Cancer Guideline Update Panel performed a side analysis of the reporting of erectile function outcomes in this clinical context as published in the medical literature., Materials and Methods: Four National Library of Medicine PubMed(R) Services literature searches targeting articles published from 1991 through early 2004 were done to derive outcome reporting (efficacy or side effects) for the treatment of clinical stage T1 or T2 N0M0 prostate cancer. A database was constructed containing descriptions relating to erectile function as well as numerical frequency rates of complete erectile dysfunction, and partial and intact erectile function for various treatments. A literature review was also done, consisting of a PubMed Services search of current measures and protocols used for assessing erectile function outcomes and a survey of consensus opinion sources on the management of male sexual dysfunctions., Results: Based on inclusion criteria 436 articles were selected. Of these articles database extraction from 100 pertaining to radical prostatectomy garnered various characterizations of erectile function, including qualitative descriptions, generic terminology and rating systems. Database extraction from 31 articles, in which results for at least 50 patients were reported, yielded ranges of rates for complete erectile dysfunction, partial erectile function and intact erectile function that were 26% to 100%, 16% to 48% and 9% to 86% for radical prostatectomy, 8% to 85%, 21% to 47% and 36% to 63% for external beam radiation, and 14% to 61%, 21% and 18% for interstitial radiation, respectively. The literature review showed an evolution in standards for studying and reporting erectile function outcomes., Conclusions: Clinical studies reporting erectile function outcomes after localized prostate cancer treatment often demonstrate poorly interpretable and inconsistent manners of assessment as well as widely disparate rates of erectile dysfunction and erectile function. Future studies must apply scientifically rigorous methodology and standard outcomes measures to advance this field of study.

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.

Purpose: The American Urological Association Prostate Guideline Update Panel was charged with updating the Guidelines for Clinically Localized Prostate Cancer. In assessing outcomes with treatment, it became apparent that a highly variable number of definitions exist with respect to biochemical recurrence. Herein, we review the variability in published definitions of biochemical recurrence and make recommendations directed toward improving this terminology by recommending a standard definition in patients treated with radical prostatectomy., Materials and Methods: Four PubMed literature searches were performed between May 2001 and April, 2004 and covered articles published from 1991 through early 2004. The search terms included the MeSH major headings of prostate cancer and prostatic neoplasm. All potentially relevant articles were retrieved and a more detailed screen for relevance was performed. An article was considered relevant if it reported treatment outcomes of patients with clinical T1 or T2N0M0 prostate cancer. Data extractors recorded the definition of biochemical recurrence and definitions were then collapsed into categories representing the same criteria. The results of biochemical failure were subcategorized by initial treatment., Results: Of 13,800 citations, a total of 436 articles were selected. Among these, a total of 145 articles contained 53 different definitions of biochemical recurrence for those treated with radical prostatectomy. Of these, the most common definition (35) was a prostate specific antigen of >0.2 ng/mL or a slight variation thereof. In addition, a total of 208 articles reported 99 different definitions of biochemical failure among those treated with radiation therapy. Of these, the American Society for Therapeutic Radiology and Oncology definition (70) and/or a variation thereof was the most commonly reported. In total, 166 different definitions of biochemical failure were identified. Following radical prostatectomy, the Panel recommends defining biochemical recurrence as an initial serum prostate specific antigen of > or =0.2 ng/mL, with a second confirmatory level of prostate specific antigen of >0.2 ng/mL. The Panel recommends the use of the American Society for Therapeutic Radiology and Oncology criteria for patients treated with radiation therapy and acknowledges that these criteria will soon be updated although not yet published., Conclusions: A high degree of variability in the definition of biochemical recurrence exists following treatment for localized prostate cancer. Strict definitions for biochemical recurrence are necessary to identify men at risk for disease progression and to allow meaningful comparisons among patients treated similarly. The Panel acknowledges the American Society for Therapeutic Radiology and Oncology criteria and future modifications thereof for those receiving radiation therapy and recommends the newly developed American Urological Association criteria for those treated with radical prostatectomy. The purpose for the establishment of this standard is for data reporting purposes and for comparison of similarly treated patients. It is not intended to represent a threshold value for which to initiate treatment. The Panel acknowledges that the clinical decision to initiate treatment will be dependent on multiple factors including patient and physician interaction rather than a specific prostate specific antigen threshold value.

Synthetic mid-urethral slings are currently the most common surgical procedure performed for the treatment of female stress urinary incontinence. The transobturator mid-urethral sling technique was originally described in 2001 and has since become widely accepted due to its high rate of success and low complication rate. Although complications remain infrequent, when they do occur, there is potential for significant patient morbidity. We report a case of a vesicovaginal fistula following a transobturator mid-urethral sling procedure and describe successful reconstruction with transvaginal sling excision, fistula closure, and placement of an autologous pubovaginal sling.

Aims: We sought to explore our patient outcomes utilizing sacral neuromodulation in the management of refractory urinary urge incontinence following urogynecological surgical procedures., Methods: A total of 25 women with urinary urge incontinence following urogynecological surgery were selected for SNS therapy and retrospectively analyzed. All patients completed a comprehensive urological evaluation. Clinical data was recorded to determine outcomes and identify parameters that would be predictive of response to neuromodulation. Outcomes were determined via subjective patient questionnaire and graded as follows: significant response (> or =80% improvement), moderate response (> or =50% and <80% improvement), and poor response (<50% response)., Results: Nineteen patients had a previous pubovaginal sling (10 with concomitant pelvic prolapse repair), 3 a previous retropubic suspension, and 3 a transperitoneal vesicovaginal fistula repair. Urethrolysis was performed in 4 patients to alleviate bladder outlet obstruction prior to sacral neuromodulation. Mean patient age was 59.8 years and length of follow-up was 7.2 months. Twenty-two women (88%) had the IPG placed during a Stage 2 procedure. Twenty patients maintained at least a 50% improvement in clinical symptoms at last follow-up and 6 patients were continent. Overall, the number of pads/day improved from 4.2 to 1.1 (P < 0.001). There were no significant differences in response to neuromodulation based upon age, duration of symptoms, type of surgery, or urodynamic parameters., Conclusion: Sacral neuromodulation appears to be an effective therapy in patients with refractory urge incontinence following urogynecological surgery. Larger prospective studies with longer follow-up are needed to assess the durability of this therapeutic modality., (Copyright 2006 Wiley-Liss, Inc.)

Early studies of extended-release oxybutynin in patients with overactive bladder used adjusted-dose regimens ranging from 5 to 30 mg/day to achieve an optimal balance of efficacy and tolerability. The safety and tolerability of extended-release oxybutynin at a fixed dose of 10 mg once daily (commonly prescribed in clinical practice) is reported using pooled data from 2 multicenter, randomized, double-blind, parallel-group trials with a similar study design. One study compared extended-release oxybutynin with immediate-release tolterodine 2 mg bid. The other study compared extended-release oxybutynin with extended-release tolterodine 4 mg qd. In total, 576 patients received extended-release oxybutynin, 399 received extended-release tolterodine, and 193 received immediate-release tolterodine. The incidence of adverse events (AEs) was similar in the three treatment groups (extended-release oxybutynin, 70%; extended-release tolterodine, 64%; and immediate-release tolterodine, 79%). The most common adverse event was dry mouth (extended-release oxybutynin, 29%; extended-release tolterodine, 22%; and immediate-release tolterodine, 33%). Other AEs occurring in more than 5% of patients in any treatment group included constipation, diarrhea, headache, urinary tract infection, pain, dyspepsia, and peripheral edema, with no apparent difference across treatment groups. Most AEs (>90%) were mild or moderate in intensity in all treatment groups. The proportion of patients who discontinued study medication due to AEs was 6.1, 4.8, and 7.8% in the extended-release oxybutynin, extended-release tolterodine, and immediate-release tolterodine groups, respectively. In total, 1.2, 1.0, and 1.6% of patients in the extended-release oxybutynin, extended-release tolterodine, and immediate-release tolterodine groups, respectively, discontinued study medication due to dry mouth.

Objective: The objective of the study was to determine the impact of overactive bladder on sexual function from a preliminary analysis of the Multicenter Assessment of Transdermal Therapy in Overactive Bladder with Oxybutynin study., Study Design: The Multicenter Assessment of Transdermal Therapy in Overactive Bladder with Oxybutynin study was an open-label, prospective trial of 2878 subjects with overactive bladder, treated with transdermal oxybutynin for 6 months or less. The impact of overactive bladder on sexual function before and after treatment was assessed via item responses from the King's Health Questionnaire and Beck Depression Inventory-II (kappa-test)., Results: At baseline, 586 (23.1%) reported that overactive bladder had an impact on their sex life. Coital incontinence in 569 (22.8%) decreased after treatment to 438 (19.3%). Effects of overactive bladder on subjects' sex lives improved in 19.1% (worsened in 11.2%), and the effect on relationships with partners improved in 19.6% (worsened in 11.9%). Reduced interest in sex, reported by 52.1% at baseline, improved significantly. (all P < .0001)., Conclusion: Overactive bladder negatively affects sexual function. Treatment with transdermal oxybutynin improved sexual function and marital relationships.

Overactive bladder is commonly treated with oral anticholinergic drugs such as oxybutynin chloride. Although oral anticholinergic agents have been effective in controlling urinary urgency and frequency and in decreasing incontinence episodes, adverse events, particularly dry mouth, often cause patients to discontinue oral therapy and to endure incontinence. Oxybutynin can be delivered transcutaneously, maintaining the efficacy of oral oxybutynin while significantly minimizing the side effects (eg, dry mouth) that may complicate therapy. By avoiding hepatic and gastrointestinal metabolism of oxybutynin, less N-desethyloxybutynin is produced (this compound is deemed responsible for the anticholinergic side effects such as dry mouth). This novel oxybutynin formulation offers patients who have overactive bladder and urge urinary incontinence a well-tolerated option for managing the symptoms of overactive bladder.

Overactive bladder (OAB) affects millions of individuals and may severely impair the quality of life of those affected. The contribution of human behavior to manifestations of this symptom complex remains poorly understood. Continued evolution of our understanding of the pathophysiology of OAB has identified contributory mechanisms, which in turn may open new therapeutic avenues. Recent improvements in drug delivery systems represent advances in the management of OAB. However, more complete symptom control with greater tolerability is desirable; this awaits the development of agents specific for newly emerging and as yet unidentified pathophysiologic pathways. Importantly, as understanding of outcomes assessment in OAB matures, refined assessments of disease severity, response to intervention, and patient preference should be possible.

Overactive bladder is commonly treated with oral anticholinergic drugs such as oxybutynin chloride. Although oral anticholinergic agents have been effective in controlling urinary urgency and incontinence, adverse events, particularly dry mouth, often cause patients to discontinue oral therapy and to endure incontinence. Oxybutynin can be delivered transcutaneously, maintaining the efficacy of oral oxybutynin while significantly minimizing side effects (e.g., dry mouth) that may complicate therapy. By avoiding hepatic and gastrointestinal metabolism of oxybutynin, less N-desethyloxybutynin (N-DEO) is produced and this compound is deemed to be responsible for anticholinergic side effects such as dry mouth. This novel oxybutynin formulation offers patients with OAB and urge urinary incontinence a well-tolerated option for managing the symptoms of overactive bladder.

Although occurring with somewhat less frequency now than historically reported, outlet obstruction after incontinence surgery continues to be a source of postoperative patient dissatisfaction and therapeutic dilemma. Several techniques have been described that fall under the rubric of urethrolysis, including sling incision, sling lysis with explantation, and formal vaginal or retropubic urethrolysis (incision and disruption of bladder neck and urethral fibrosis). Surgical approaches have included vaginal, retropubic, or combined techniques with or without the use of adjunctive steps such as graft interposition. However, evidence emanating from reports of these varied techniques has been incomplete due to variability in outcomes presentation, lack of longevity of follow-up, or problematic study design. Nonetheless, the bulk of clinical evidence supports the efficacy of urethrolysis as an intervention for outlet obstruction after stress incontinence surgery. However, persistent irritative bladder symptoms remain bothersome for some women and, in addition, the recurrence of stress incontinence also may complicate the technique of urethrolysis. Management of these potential adverse outcomes also has been inconsistent, with some authorities routinely performing repeat incontinence surgery at the time of urethrolysis and others preferring to assess continence status after convalescence from urethrolysis. The differences among the types of urethrolysis and the results of each type are reviewed in this article in light of evolving definitions of outlet obstruction, diagnosis, and definition in women.

Purpose: Voiding dysfunction following genitourinary erosion of synthetic mid urethral slings is not clearly reported. We investigated the incidence of voiding dysfunction in patients following sling excision due to vaginal, urethral or intravesical mesh erosion., Materials and Methods: Retrospective review identified 19 patients with genitourinary erosion of polypropylene mesh slings. Comprehensive urological evaluation was performed in all patients, and perioperative and postoperative data were analyzed. Voiding dysfunction was defined as refractory storage symptoms, emptying symptoms and pelvic pain. All subsequent medical and surgical interventions were recorded., Results: In 19 patients a total of 11 vaginal, 7 intravesical and 5 urethral erosions occurred. Mean patient age was 52 years (range 32 to 69) and average followup was 8.4 months (range 3 to 34). Average time from symptom onset to sling removal was 10.1 months (range 1.5 to 38). Of the 19 patients 14 (74%) presented with multiple symptoms. Symptoms varied, including refractory pain, recurrent infections and bladder storage/emptying dysfunction. Urodynamic studies were abnormal preoperatively and postoperatively in 9 of 13 (69%) and 4 of 6 patients (67%), respectively. Following surgery lower urinary tract symptoms resolved completely in only 4 of the 19 patients (21%). Stress incontinence recurred in 8 of the 19 patients (42%). Five patients underwent simultaneous pubovaginal sling, of whom none had recurrent stress urinary incontinence. Only 9 patients (47%) considered themselves dry with no pads following surgery. Four patients required further surgery for refractory voiding symptoms., Conclusions: Voiding dysfunction is not an uncommon finding after sling excision in the setting of genitourinary erosion. It may cause additional patient morbidity.