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Introduction and Objectives: Relevant, meaningful, and achievable data points are critical in objectively assessing quality, utility, and outcomes in female stress urinary incontinence (SUI) surgery. A minimum data set female SUI surgery studies was proposed by the first American Urological Association guidelines on the surgical management of female SUI in 1997, but recommendation adherence has been suboptimal. The Female Stress Urinary Incontinence Surgical Publication Working Group (WG) was created from members of several prominent organizations to formulate a recommended standard of study structure, description, and minimum outcome data set to be utilized in designing and publishing future SUI studies. The goal of this WG was to create a body of evidence better able to assess the outcomes of female SUI surgery., Methods: The WG reviewed the minimum data set proposed in the 1997 AUA SUI Guideline document, and other relevant literature. The body of literature was examined in the context of the profound changes in the field over the past 25 years. Through a DELPHI process, a standard study structure and minimum data set were generated. Care was taken to balance the value of several meaningful and relevant data points against the burden of creating an excessively difficult or restrictive standard that would disincentivize widespread adoption and negatively impact manuscript production and acceptance., Results: The WG outlined standardization in four major areas: (1) study design, (2) pretreatment demographics and characterization of the study population, (3) intraoperative events, and (4) posttreatment evaluation, and complications. Forty-two items were evaluated and graded as: STANDARD-must be included; ADDITIONAL-may be included for a specific study and is inclusive of the Standard items; OPTIMAL-may be included for a comprehensive study and is inclusive of the Standard and Additional items; UNNECESSARY/LEGACY-not relevant., Conclusions: A reasonable, achievable, and clinically meaningful minimum data set has been constructed. A structured framework will allow future surgical interventions for female SUI to be objectively scrutinized and compared in a clinically significant manner. Ultimately, such a data set, if adopted by the academic community, will enhance the quality of the scientific literature, and ultimately improve short and long-term outcomes for female patients undergoing surgery to correct SUI., (© 2024 The Authors. Published by Wiley Periodicals LLC, by Elsevier B.V on behalf of International Continence Society, and by Wolters Kluwer Health, Inc. on behalf of American Urogynecologic Society.)

Purpose: The efficacy and safety of vibegron, a β 3 -adrenergic receptor agonist, was assessed among men with symptoms of overactive bladder (OAB) receiving pharmacologic treatment for benign prostatic hyperplasia (BPH) in a phase 3 randomized controlled trial., Materials and Methods: Men ≥ 45 years with OAB symptoms and BPH, treated with α-blocker with/without 5α-reductase inhibitors, were randomized 1:1 to vibegron or placebo for 24 weeks. Coprimary end points were change from baseline at week 12 in mean daily micturitions and urgency episodes. Secondary end points were change from baseline at week 12 in mean nightly nocturia and daily urge urinary incontinence episodes, International Prostate Symptom Score‒storage score, and volume voided per micturition. Safety was evaluated via adverse events (AEs)., Results: Of 1105 participants randomized, 965 (87.3%) completed the trial. At week 12, vibegron was associated with significant reductions vs placebo in daily micturitions (least squares mean difference [95% CI], -0.74 [-1.02, -0.46]; P < .0001) and urgency episodes (-0.95 [-1.37, -0.54]; P < .0001). Vibegron was also associated with significant improvements vs placebo at week 12 in nocturia episodes (least squares mean difference, -0.22 [-0.36, -0.09]; P = .002), urge urinary incontinence episodes (-0.80 [-1.33, -0.27]; P = .003), International Prostate Symptom Score‒storage scores (-0.9 [-1.2, -0.6]; P < .0001), and volume voided (15.07 mL [9.13-21.02]; P < .0001). AE rates were similar in vibegron (45.0%) and placebo (39.0%) arms; AEs occurring in ≥ 2% of participants were hypertension (9.0% vs 8.3%), COVID-19 (4.0% vs 3.1%), UTI (2.5% vs 2.2%), and hematuria (2.0% vs 2.5%)., Conclusions: In this trial, vibegron met all primary and secondary end points and was safe and well tolerated in men with OAB symptoms and pharmacologically treated BPH.

Background: Transient increases in postvoid residual urine volume (PVR) requiring clean intermittent catheterization (CIC) have occurred with onabotulinumtoxinA treatment for overactive bladder (OAB)., Objective: To evaluate onabotulinumtoxinA safety and the effect of age, gender, and maximum PVR (PVR max ) on CIC initiation in adults with OAB and urinary incontinence (UI)., Design Setting and Participants: This was a pooled post hoc analysis of four placebo-controlled, multicenter randomized trials that included adults with idiopathic OAB after first onabotulinumtoxinA treatment (NCT00910845, NCT00910520, NCT01767519, NCT01945489). Patients had at least three urgency UI episodes over 3 d and at least eight micturitions per day, had inadequate management with at least one anticholinergic agent, and were willing to use CIC., Outcome Measurements and Statistical Analysis: We measured the following outcomes: PVR max within 12 wk after first treatment; CIC incidence; estimated functional capacity; PVR ratio (PVR/estimated functional capacity)., Results and Limitations: Of 1504 patients, 87.7% were women and 88.8% were White. The mean age was 60.5 yr across 10-yr age groups, baseline PVR was 13.8-35.0 ml, and estimated functional capacity was 293.5-475.7 ml. Mean baseline PVR was 21.3 ml overall versus 34.0 ml in the group that started CIC. The CIC incidence was 6.2% for women (range 1.1-8.4%) and 10.5% for men (range 0-14.6%). Higher CIC rates were observed for PVR max >350 ml (women 91.9%, men 84.6%) in comparison to PVR max of 201-350 ml (women 32.5%, men 17.4%) and PVR max <200 ml (women 1.2%, men 1.6%). Overall, 2/1504 patients (both women) were unable to void spontaneously. The mean PVR ratio was highest at week 2. Some subgroups had small sample sizes., Conclusions: CIC incidence was low overall, was less frequent for women, was rare with PVR max ≤200 ml, and did not appear to correlate with baseline PVR., Patient Summary: After onabotulinumtoxinA treatment for OAB, patients sometimes insert a catheter to help in emptying their bladder after urinating. In this study, few patients needed a catheter, especially when less urine volume remained after urination., (© 2023 The Author(s).)

Objective: To assess contemporary adherence to the minimum data set proposed for future publication in the 1997 American Urological Association (AUA) guidelines on the surgical management of female SUI in 1997. guidelines among recently published literature., Materials and Methods: We reviewed all publications included in the AUA/SUFU Surgical Treatment of Female SUI Guidelines and included articles that reported surgical outcomes for SUI treatment. They were abstracted for the reporting of the previously defined 22 data points. Each article received a compliance score as a percent of parameters met out of the 22 data points., Results: Three hundred eighty articles from the 2017 AUA guidelines search, in combination with an independent updated literature search were included. There was an average compliance score of 62%. The best compliance rates for individual data points were: defined criteria for success (95%) and patient history (97%). The lowest compliance rates were: minimum follow-up >48 months (8%) and post-treatment micturition diary (17%). There was no difference between mean rates of reporting for articles before and after the SUFU/AUA 2017 guidelines (61% pre vs 65% post)., Conclusion: Adherence to reporting the most recent minimum standards in the current SUI literature is largely suboptimal. This apparent lack of compliance may suggest a role for a more stringent editorial review process, or alternatively that the prior suggested data set was overly burdensome and/or irrelevant., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Purpose of Review: Urethral bulking agents are an effective treatment for stress urinary incontinence in select females. The material and techniques used for urethral bulking are constantly evolving. With the introduction of several new agents, there is an ongoing debate over which agent is the most effective, durable, and safe., Recent Findings: Current available bulking agents include Bulkamid®, Macroplastiue®, Durasphere®, Coaptite®, or Urolastic®. Each of these agents has its own biophysical properties that affect its efficacy and safety. Evidence evaluating bulking agents has increased over time but there is no definitive data that suggest superiority of one agent over another. The ideal urethral bulking agent for female stress incontinence has yet been identified. Currently available agents have acceptable short-term and medium-term efficacy with few adverse events., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Objective: To identify potential technical factors during initial mid-urethral sling (MUS) placement that contribute to subsequent sling revision procedures., Methods: A retrospective chart review was performed examining synthetic MUS reoperations at a single institution from 2008-2020. The implanting surgeon's operative note, when available, was critically reviewed with respect to trocar placement, sling location, and tensioning technique. The reoperative report was reviewed for aberrant intraoperative findings relating to the index surgery., Results: A total of 306 women underwent revision of their MUS. Operative reports from the implanting surgeon were available for 276 (90.2%) women. Review of index operative reports revealed 47 unambiguous descriptions of improper technique, including 19 cases of described excessive tensioning and 2 cases of MUS placement despite noted urethral injury during the index case. Indications for reoperation were clinical obstruction (63%), pain (40%), and mesh erosion/exposure (33%). In 186 (67.4%) women, there was an intraoperative finding during the revision that likely contributed to the need for reoperation. Among these 186 women, 110 (59.1%) slings were noted to have been placed too proximally, 78 (41.9%) were over-suspended, and 57 (30.6%) were placed too deep in the periurethral fascia., Conclusion: Review of the index operative note and findings at operative re-exploration of MUS surgeries, often reveals evidence that the initial MUS implantation was technically suboptimal. Such findings suggest that intraoperative surgical technique is a critically important factor contributing to postoperative complications in MUS surgery. This underscores the importance of surgical training and adherence to surgical principles during the placement of a synthetic MUS., (Copyright © 2021 Elsevier Inc. All rights reserved.)

A Cowper's Duct syringocele is a rare diagnosis and currently there exists no clinical guidelines for evaluation and management. This clinical challenge illustrates the case presentation, evaluation, diagnosis, and treatment options for of a newly diagnosed Cowper's Duct syringocele., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Aims: To identify risk factors for urinary retention following AdVance™ Sling placement using preoperative urodynamic studies to evaluate bladder contractility., Methods: A multi-institutional retrospective review of patients who underwent an AdVance Sling for post-prostatectomy stress urinary incontinence from 2007 to 2019 was performed. Acute urinary retention (AUR) was defined as the complete inability to void or elevated post-void residual (PVR) leading to catheter placement or the initiation of intermittent catheterization at the first void trial postoperatively. Bladder contractility was evaluated based on preoperative urodynamics., Results: Of the 391 patients in this study, 55 (14.1%) experienced AUR, and 6 patients (1.5%) had chronic urinary retention with a median follow-up of 18.1 months. In total, 303 patients (77.5%) underwent preoperative urodynamics, and there was no significant difference between average PdetQmax (26.4 vs. 27.4 cmH 2 O), Qmax (16.6 vs. 16.2 ml/s), PVR (19.9 vs. 28.1 ml), bladder contractility index (108 vs. 103) for patients with or without AUR following AdVance Sling. Impaired bladder contractility preoperatively was not predictive of AUR. Time to postoperative urethral catheter removal was predictive of AUR (odds ratio, 0.83; 95% confidence interval, 0.73-0.94; p = .003)., Conclusions: Chronic urinary retention after AdVance Sling placement is uncommon and acute retention is generally self-limiting. No demographic or urodynamic factors were predictive of AUR. Patients who developed AUR were more likely to have their void trials within 2 days following AdVance Sling placement versus longer initial catheterization periods, suggesting that a longer duration of postoperative catheterization may reduce the occurrence of AUR., (© 2020 Wiley Periodicals LLC.)

Introduction and Hypothesis: To examine urinary retention (UR) after female urethral sling placement in patients with or without detrusor underactivity (DU) or Valsalva voiding whose urodynamics (UDS) accurately reproduced voiding symptoms to determine whether the reproduction of voiding symptoms on UDS in those with DU is predictive of UR after sling placement., Methods: We performed a review of patients undergoing urethral sling procedures for stress urinary incontinence (SUI) looking specifically at the occurrence of short- and long-term urinary retention. Preoperative UDS data were obtained from a prospectively acquired UDS database in which patients were directly queried at the time of the UDS study about whether the filling and/or storage phase of the study reproduced their usual symptoms., Results: Of the 141 women who had a urethral sling procedure, 124 (87.9%) had preoperative UDS. Of those who had UDS, 41 (33%) had de novo UR at some point postoperatively. Compared to those without DU, patients with DU and/or Valsalva voiding were more likely to have UR (75.6% vs. 56.6%, p = 0.04). There was no difference in association of UR in patients with DU/Valsalva voiding whose UDS reproduced voiding symptoms compared to those with DU/Valsalva voiding whose UDS did not reproduce symptoms (OR 1.01, CI 0.32-3.19, p 0.98)., Conclusions: This study found that patients with DU/Valsalva voiding had an increased association with UR but did not find reproduction of symptoms on UDS to correlate with UR in either those with DU/Valsalva voiding or with normal bladder contractility.

Polypropylene (PP) mesh has been used as a primary or adjuvant material for vaginal reconstruction for both stress urinary incontinence (SUI) and pelvic organ prolapse (POP) for decades. Whether polypropylene is the optimal material for such indications has been called into question by clinicians, regulatory agencies and the public in several countries around the world. This paper is a report of presentations and subsequent discussion at the annual International Consultation on Incontinence Research Society (ICI-RS) Meeting in June 2019 in Bristol, UK on the proposal "Is polypropylene mesh material fundamentally safe for use as a reconstructive material in vaginal surgery?" in which several of the salient issues were presented and discussed., (© 2020 Wiley Periodicals, Inc.)

Aims: Two phase 1 trials were performed in healthy women with the overactive bladder (OAB) syndrome and urodynamically demonstrated detrusor overactivity (DO), with the aim to demonstrate the safety and potential efficacy of URO-902, which comprises a gene therapy plasmid vector expressing the human big potassium channel α subunit., Methods: ION-02 (intravesical instillation) and ION-03 (direct injection) were double-blind, placebo-controlled, multicenter studies without overlap in enrollment between studies. Active doses were administered and evaluated sequentially (lowest dose first) for safety. ION-02 participants received either 5000 µg or 10 000 µg URO-902, or placebo. ION-03 participants received either 16 000 or 24 000 µg URO-902, or placebo, injected directly into the bladder wall using cystoscopy. Primary outcome variables were safety parameters occurring subsequent to URO-902 administration; secondary efficacy variables also were evaluated., Results: Among the safety outcomes, there were no dose-limiting toxicities or significant adverse events (AEs) preventing dose escalation during either trial, and no participants withdrew due to AEs. For efficacy, in ION-02 (N = 21), involuntary detrusor contractions on urodynamics at 24 weeks in patients receiving URO-902 (P < .0508 vs placebo) and mean urgency incontinence episodes in the 5000 µg group (P = .0812 vs placebo) each showed a downward trend. In ION-03 (N = 13), significant reduction versus placebo in urgency episodes (16 000 µg, P = .036; 24 000 µg, P = .046) and number of voids (16 000 µg, -2.16, P = .044; 24 000 µg, -2.73, P = .047) were observed 1 week after injection., Conclusion: Promising safety and efficacy results in these preliminary phase 1 studies suggest gene transfer may be a promising therapy for OAB/DO, warranting further investigation., (© 2020 The Authors. Neurourology and Urodynamics published by Wiley Periodicals, Inc.)

Purpose: We performed a clinical feasibility trial to evaluate the safety and efficacy of a fully implanted, primary battery powered, nickel sized and shaped neuromodulation device called the eCoin® for tibial nerve stimulation to treat refractory urgency urinary incontinence., Materials and Methods: This prospective, single arm, open label study included 46 participants with refractory urgency urinary incontinence. It was performed at multiple sites in the United States and New Zealand. The device was implanted in the lower leg over the tibial nerve and activated after 4 weeks. Bladder diary data and validated quality of life instruments were collected 3 and 6 months after activation and compared to baseline values., Results: The mean ± SD age of participants was 63.4 ± 11.5 years and 45 (98%) were female. Episodes of urgency urinary incontinence were reduced a relative median of 71% after 3 months of treatment (4.2 vs 1.7 daily episodes at 3 months, p = 0.001). A 50% or greater decrease in reported episodes of urgency urinary incontinence was observed in 32 of 46 participants (69.6%) at 3 months with more than 20% dry at 3 and 6 months. I-QOL (Incontinence Quality of Life) scores improved an average of 25.9 points and 33 of 46 patients (72%) indicated improvement in symptoms. A single serious adverse event secondary to wound care resolved with intravenous antibiotics., Conclusions: The implantable neuromodulation device was a safe and effective treatment of urgency urinary incontinence associated with overactive bladder syndrome with a significant reduction or resolution of symptoms and no significant safety concerns.

Objectives: The "Stress Incontinence Control, Efficacy and Safety Study" (SUCCESS) is a phase III study of the Vesair Balloon in women with stress urinary incontinence who had failed conservative therapy, and either failed surgery, were not candidates for surgery, or chose not to have surgery. The safety and efficacy of the balloon at 12 months is reported for those participants in the treatment arm who elected to continue with the SUCCESS trial beyond the primary end point at 3 months., Methods: The SUCCESS trial is a multicenter, prospective, single-blinded, randomized, sham-controlled study. Participants were randomized on a 2.33:1 basis to either Vesair Balloon placement or placebo. The primary efficacy end point was a composite of both a greater than 50% reduction from baseline on 1-hour provocative pad weight test and an at least 10-point improvement in symptoms on the Incontinence Quality of Life questionnaire assessed at the 3-month study visit. Patients in the treatment arm who opted to continue in the trial were followed up prospectively up to 12 months., Results: A total of 221 participants were randomized, including 157 in the treatment arm and 64 in the control arm. Sixty-seven participants in the treatment arm (42.7% of participants enrolled) were evaluated at 12 months, with 56.3% achieving the composite end point and 78.7% having greater than 50% reduction in pad weight from baseline in a per-protocol analysis. In an intent-to-treat analysis treating all participants who did not continue with the balloon as failures, 24% of the participants achieved the composite end point and 33.6% had a greater than 50% reduction in pad weight from baseline. Treatment-related adverse events in this group included dysuria (40.1%), gross hematuria (36.9%), and urinary tract infection (26.1%)., Conclusions: In this phase III trial, symptom relief was maintained for those participants who continued therapy for 12 months. The balloon was found to be safe with no device- or procedure-related serious adverse events reported. Additional studies are warranted to determine which patient populations are more tolerant of the balloon and to assess the efficacy and safety of its longer-term use. Additional screening methods, including screening patients for balloon tolerability, are warranted to reduce participant withdrawals.

Aims: The SUCCESS trial is a phase III study of the Vesair® balloon in the United States for female stress urinary incontinence (SUI). The purpose of this manuscript is to present the 3 month primary efficacy and tolerability outcome data., Methods: The SUCCESS trial is a multi-center, prospective, single blind, randomized, sham-controlled study. Subjects were randomized on a 2.33:1 basis to either Vesair balloon placement or placebo. The primary efficacy endpoint was a composite of both a >50% reduction from baseline on 1 h provocative pad weight test and a ≥10-point improvement in symptoms on the Incontinence Quality of Life Survey (I-QOL) questionnaire assessed at the 3 month study visit., Results: A total of 221 subjects were randomized, including 157 treatment arm subjects and 64 controls. The 3 month composite primary efficacy endpoint was achieved in 42.1% of treatment group subjects compared with 28.1% of controls on intention-to-treat analysis (p = 0.046). Treatment arm subjects were significantly more likely to report at least a 50% reduction in incontinence frequency on 7-day voiding diary (55.2% vs 32.3%, P = 0.002, ITT) and more commonly reported their incontinence was improved on Patient Global Impression of Improvement in Incontinence (PGI-I) at 3 months compared with controls (58.0% vs 37.7%, P = 0.007, ITT). No device- or procedure-related serious adverse events nor unanticipated adverse events were reported and no cases of urinary retention were observed. All adverse events fully resolved following balloon removal., Conclusions: In this phase three trial, the Vesair intravesical balloon achieved 3 month primary and secondary endpoints both objectively and subjectively., (© 2017 Wiley Periodicals, Inc.)

Aims: To assess surgical outcomes of concomitant treatment of SUI at time of transvaginal urethral diverticulectomy (TVUD) based on a selective approach., Methods: Following Institutional Review Board (IRB) approval, we identified patients with a UD and SUI who underwent TVUD between July 2004 and January 2016. SUI was documented before and after surgery using subjective and objective parameters. Autologous pubovaginal slings (APVS) were used selectively based on surgeon and patient preference., Results: A total of 61 patients underwent surgical treatment of urethral diverticula; 39 patients with UD and concomitant SUI. Mean age was 53 years. Mean follow-up was 16.2 months. There were 24 patients (62%) with SUI that underwent concomitant APVS. There was resolution of SUI in 20 of 24 patients (83%) who underwent a simultaneous APVS compared to 8 of 15 patients (53%) who underwent TVUD without APVS. Surgery resulted in the improvement or resolution of the majority of preoperative symptoms including recurrent urinary tract infection (UTI) (82% vs 15%), dyspareunia (64% vs 8%), and urgency (56% vs 13%) (preoperative vs postoperative)., Conclusions: Female UD is often associated with SUI. Concomitant surgical treatment of UD and SUI often results in satisfactory control of bothersome SUI as well as other urinary symptoms such as UTI, dyspareunia and urgency. Treatment of SUI with APVS when undergoing TVUD is feasible with satisfactory outcomes., (© 2017 Wiley Periodicals, Inc.)

Aim: Central efferent and afferent neural pathways to and from the human urinary bladder are well-characterized, but the location and arborization of these nerves as they traverse the serosa, muscularis, and urothelial layers are not clearly defined. The purpose of this study was to create a three dimensional map of the innervation of the human bladder trigone from the extrinsic perivesical adventitial nerve trunks to the urothelium., Methods: A male and a female human bladder were harvested from fresh frozen cadavers and fixed in formalin. The bladder neck and trigone region were serially sectioned (5 μm) and every 20th slide was stained (S100), scanned and aligned to create 3D maps., Results: Nerve penetration into the detrusor muscle occurs with the highest frequency at the bladder neck and interureteric ridge. Nerves traveling parallel to the bladder lumen do so in the adventitia, beyond the outer border of detrusor. In females, the depth of these nerve bands is uniform at 0.7-1.7 cm below the luminal surface, the outer limits of which include the anterior vaginal wall. In the male, depth is more variable owing to detrusor hypertrophy with the minimum depth of nerves approximately 0.5 cm near the interureteric ridge and over 1 cm near the bladder neck., Conclusions: Myelinated neural pathways traversing in the human bladder in the region of the trigone have a discreet regional density. This 3D map of trigonal innervation may provide guidance to more precisely direct therapies for urinary incontinence or pelvic pain. Neurourol. Urodynam. 36:1015-1019, 2017. © 2016 Wiley Periodicals, Inc., (© 2016 Wiley Periodicals, Inc.)

Purpose: We assessed the year-to-year consistency of outcomes in patients with urinary incontinence due to neurogenic detrusor overactivity who completed 4 years of onabotulinumtoxinA treatment., Materials and Methods: Eligible patients who completed a 52-week phase 3 trial of onabotulinumtoxinA for urinary incontinence could enter a 3-year open label extension study of onabotulinumtoxinA 200 or 300 U administered as needed for symptom control. This analysis focused on 227 patients who completed the 4-year study. Outcomes assessed by year of treatment included mean treatments per year, mean change from baseline at week 6 in urinary incontinence episodes per day and the I-QOL (Incontinence Quality of Life) total summary score, the proportion of patients with 50% or greater and 100% reductions in urinary incontinence episodes per day, duration of effect and adverse events., Results: Patients reported 4.3 urinary incontinence episodes per day at baseline and received 1.4 to 1.5 onabotulinumtoxinA treatments per year. The decrease in urinary incontinence following onabotulinumtoxinA consistently ranged from -3.4 to -3.9 episodes per day across 4 years. A high proportion of patients achieved 50% or greater and 100% urinary incontinence reductions in each year (range 86.6% to 94.1% and 43.6% to 57.4%, respectively). Consistent and clinically relevant improvements in I-QOL scores were observed in each treatment year. The overall median duration of effect of onabotulinumtoxinA was 9.0 months or greater (range 3.0 to 49.2) and 26.0% or more of patients experienced a duration of effect of 12 months or greater. The most common adverse event was urinary tract infection with no increased incidence with time., Conclusions: Patients with neurogenic detrusor overactivity who completed 4 years of onabotulinumtoxinA treatment experienced a consistent duration of treatment effect and year-to-year improvements in urinary incontinence and quality of life with no new safety signals., (Copyright © 2016 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Purpose: We reviewed the outcomes of the autologous fascial pubovaginal sling as a salvage procedure for recurrent stress incontinence after intervention for polypropylene mesh erosion/exposure and/or bladder outlet obstruction in patients treated with prior transvaginal synthetic mesh for stress urinary incontinence., Materials and Methods: In a review of surgical databases at 2 institutions between January 2007 and June 2013 we identified 46 patients who underwent autologous fascial pubovaginal sling following removal of transvaginal synthetic mesh in simultaneous or staged fashion. This cohort of patients was evaluated for outcomes, including subjective and objective success, change in quality of life and complications between those who underwent staged vs concomitant synthetic mesh removal with autologous fascial pubovaginal sling placement., Results: All 46 patients had received at least 1 prior mesh sling for incontinence and 8 (17%) had received prior transvaginal polypropylene mesh for pelvic organ prolapse repair. A total of 30 patients underwent concomitant mesh incision with or without partial excision and autologous sling placement while 16 underwent staged autologous sling placement. Mean followup was 16 months. Of the patients 22% required a mean of 1.8 subsequent interventions an average of 6.5 months after autologous sling placement with no difference in median quality of life at final followup. At last followup 42 of 46 patients (91%) and 35 of 46 (76%) had achieved objective and subjective success, respectively. There was no difference in subjective success between patients treated with a staged vs a concomitant approach (69% vs 80%, p = 0.48)., Conclusions: Autologous fascial pubovaginal sling placement after synthetic mesh removal can be performed successfully in patients with stress urinary incontinence as a single or staged procedure., (Copyright © 2016 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Aims: To identify the self-reported treatment goals of patients with urinary incontinence (UI) due to neurogenic detrusor overactivity (NDO), determine whether patients achieved their goals following onabotulinumtoxinA treatment, and assess impact of neurogenic disease (multiple sclerosis or spinal cord injury) and/or clean intermittent catheterization (CIC) on goal achievement., Methods: Data from two Phase III studies of onabotulinumtoxinA 200U (n = 227) or placebo (n = 241) in NDO patients (≥14 UI episodes/week; inadequately managed by anticholinergics) were pooled for analysis. At baseline, patients listed their top two qualitative treatment goals, which were distributed into eight subcategories. Six weeks post-treatment, patients rated whether they achieved their goals (5-point Likert scale). The frequency distribution of goals, the proportion of patients who achieved their goals, and goal achievement by etiology and use/non-use of CIC were assessed., Results: At baseline, the most common goals were "be dry" (37.9%), "reduce other urinary symptoms" (26.4%), and "improve quality of life/sleep/emotions" (21.4%). Significantly higher proportions of onabotulinumtoxinA-treated patients achieved their overall goals versus placebo (62.0% vs. 17.2%; P <  0.001). OnabotulinumtoxinA treatment resulted in higher goal achievement in all goal categories, regardless of etiology. CIC use did not negatively impact patients' overall goal achievement; significantly higher proportions of onabotulinumtoxinA-treated patients versus placebo achieved their goals regardless of baseline catheterization use or de novo CIC during the first 6 weeks of the study., Conclusions: The majority of patients with UI due to NDO achieved their self-determined treatment goals following onabotulinumtoxinA 200U therapy, regardless of etiology or CIC use. Neurourol. Urodynam. 35:595-600, 2016. © 2015 The Authors. Neurourology and Urodynamics, published by Wiley Periodicals, Inc., (© 2015 The Authors. Neurourology and Urodynamics, published by Wiley Periodicals, Inc.)

Objective: To understand the effect of the Food and Drug Administration (FDA) public health notifications regarding transvaginal placement of surgical mesh for pelvic organ prolapsed (POP) on surgeon practice patterns in tertiary care academic medical centers., Materials and Methods: Surgical volume for procedures performed primarily by fellowship trained Female Pelvic Medicine and Reconstructive Surgery at a sampling of 8 academic institutions across the US were collected using current procedural technology codes for POP repair and revision surgeries from 2007 to 2013. SAS statistical software was used to analyze data for trends and to assess differences in number of procedures across years by performing Spearman correlation analysis and Pearson's chi-squared test. Significance of trend was defined as P <.05 for both analysis methods., Results: There has been a substantial reduction in transvaginal mesh-augmented repair of POP since the FDA warning statements of 2008 and 2011. Mesh revision surgery has increased over this same period. However, the total number of interventions for POP has remained stable over the study period. Abdominal sacrocolpopexy has increased as a whole but represents only a small percentage of total cases., Conclusion: Surgical correction of POP comprises a large portion of Female Pelvic Medicine and Reconstructive Surgery practice that continues to evolve in the aftermath of the FDA public health notifications. The utilization of transvaginal placement of surgical mesh augmented POP repair has decreased among practicing urologists at a sampling of academic institutions across the United States. Indications for surgery, complications, and outcomes were not evaluated during this retrospective study; however, such data may provide alternative insights into the reasons for the observed trends., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Objective: To determine whether complex anatomic configurations of urethral diverticula (UD), namely circumferential UD (cUD), present differently or confer a worse prognosis as compared with simple UD (sUD)., Methods: After institutional review board approval, a retrospective review of patients who underwent transvaginal urethral diverticulectomy at a single institution over an 8-year period was performed. A total of 43 patients were identified, of which 11 were found to have cUD. These lesions were repaired with complete division of the urethra to access the dorsally located portion of the UD, followed by end-to-end anastomosis for urethral reconstruction with a Martius flap and/or autologous fascial pubovaginal sling performed as needed. Presenting symptoms and surgical outcomes were reviewed., Results: Mean age was 50.9 years in the cUD vs 52.7 years in the sUD. Patients with cUD were more likely to present with stress urinary incontinence than those with sUD (90.9% vs 56.3%; P = .04). There was no statistical difference in the rate of preoperative urgency, pelvic pain and/or dyspareunia, postvoid dribbling, and urinary tract infection. Postoperatively, patients with cUD were more likely to have a urinary tract infection (27% vs 3%; P = .2); otherwise, rates of postoperative results were similar., Conclusion: Urethral transection and end-to-end anastomosis for the repair of complex UD is a feasible approach and results in similar clinical outcomes compared with the repair of sUD., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Candidates for onabotulinumtoxinA are generally patients with overactive bladder (OAB) or neurogenic detrusor overactivity (NDO) whose disease is inadequately controlled with behavioral therapy and oral medication. All patients must be willing and able to perform clean intermittent catheterization (CIC). Before the decision to administer onabotulinumtoxinA is made, the clinician should provide counseling to the patient regarding the agent's indications, proposed benefits, risks, and mode of administration. The patient should be aware that onabotulinumtoxinA takes effect after approximately 1-2 weeks and usually lasts for 4-10 months, after which repeat injections will be necessary to maintain effect. Patient preparation may include pre-treatment antibiotics and withdrawal of antiplatelet therapy or anticoagulants. Preparation of the product involves reconstitution in sterile saline and dilution according to the planned dose. Local anesthesia (e.g., bladder instillation of lidocaine) is usually administered, although general anesthesia may be used in certain cases. The injections are performed using a flexible or rigid cystoscope, and the procedure takes approximately 15 min. The initial follow-up visit occurs within 7-14 days, when evidence of adverse effects, including urinary retention, can be evaluated. Repeat injections can be scheduled as needed, but not sooner than 3 months. Currently, the total dose of onabotulinumtoxinA should not exceed 360 U in a 3-month period for all indications, including those outside the urinary tract (i.e., cosmetic, ophthalmologic, etc.). Overall, onabotulinumtoxinA is effective, generally well tolerated, safe, and is relatively simple to provide., (© 2014 Wiley Periodicals, Inc.)

Aims: To evaluate the effect of onabotulinumtoxinA on urodynamic outcomes in patients with urinary incontinence (UI) due to neurogenic detrusor overactivity (NDO)., Methods: Results from two pivotal Phase III trials (n = 691) were pooled. MS or SCI patients with NDO, received intradetrusor onabotulinumtoxinA 200 U (n = 227), 300 U (n = 223), or placebo (n = 241). Change from baseline in UI episodes/week (Week 6), maximum cystometric capacity (MCC), maximum detrusor pressure at first involuntary detrusor contraction (IDC) (PdetmaxIDC), volume at first IDC (VpmaxIDC), and detrusor compliance (DC) were measured., Results: OnabotulinumtoxinA significantly increased MCC overall (+153.6 ml with 200 U vs. +11.9 ml with placebo). Over 60% of onabotulinumtoxinA-treated patients had no IDC at Week 6; in patients with an IDC at Week 6, VpmaxIDC improved (+183.4 ml with 200 U vs. +17.5 ml with placebo), and PdetmaxIDC decreased (-32.4 cmH2O with 200 U vs. +1.1 cmH2O with placebo). OnabotulinumtoxinA-treated patients had a significant increase in DC (+59.8 ml/cmH2O with 200 U vs. -5.2 with placebo). Urodynamic improvements were comparable in patients regardless of baseline DC and corresponded with significant reductions in UI episodes/week for both onabotulinumtoxinA doses versus placebo, with no clinically relevant differences between 200 and 300 U groups. Most common adverse event was urinary tract infection (UTI); complicated UTIs were low across all treatment groups. In patients not catheterizing at baseline, a dose-dependent increase in post-void residual urine was observed at Week 2 following onabotulinumtoxinA treatment., Conclusions: OnabotulinumtoxinA significantly improved urodynamic outcomes in NDO patients, even in those with low baseline DC, and corresponded with improvements in UI episodes. Both doses of onabotulinumtoxinA were well tolerated., (© 2013 Wiley Periodicals, Inc.)

Purpose: We investigated PD-0299685, a Ca(2+) channel α2δ ligand, for interstitial cystitis pain in a randomized, double-blind, placebo controlled phase IIa study., Materials and Methods: Patients with interstitial cystitis/bladder pain syndrome received 30 or 60 mg PD-0299685 daily or placebo for 12 weeks. Primary end points were change in average daily worst pain severity score (on an 11-point numerical rating scale) and change in Interstitial Cystitis Symptom Index score from baseline to week 12. Secondary end points included global response assessment, micturition and urgency episode frequency per 24 hours and mean voided volume per micturition. Incidence of adverse events was also assessed., Results: Of 161 patients 54 received 30 mg PD-0299685 daily, 55 received 60 mg PD-0299685 daily and 52 received placebo. At week 12 the 60 mg dose produced a clinically significant reduction in daily worst pain severity score from baseline compared to placebo (treatment difference [90% CI] -0.82 [-1.72, 0.08]). A greater proportion of patients taking 60 mg PD-0299685 daily demonstrated improvement in global response assessment. PD-0299685 had no clinically significant effect on the Interstitial Cystitis Symptom Index score or urinary end points. More patients discontinued due to treatment related adverse events with 30 or 60 mg PD-0299685 daily than with the placebo., Conclusions: PD-0299685 failed to demonstrate positive proof of concept for the treatment of pain and other urinary end points associated with interstitial cystitis/bladder pain syndrome., (Copyright © 2012 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Total motile count (TMC) is a useful tool for sperm evaluation, comprising both quantitative and motility parameters. Although frequently used, TMC has not yet been evaluated as a contributory variable for intracytoplasmic sperm injection (ICSI) cycles. In this study we evaluate the possible role of TMC as a prognostic parameter in cycles designated for ICSI. We also test the existence of a possible TMC-threshold value that might be predictive for ICSI cycle outcome in the everyday practice. This is a retrospective cohort study in which the research question is addressed by a locally weighted regression (LOESS) analysis. Primary outcome measures are fertilization rate, good quality embryos rate and implantation rate. A total of 666 patients were included, contributing 1456 cycles. The effect of TMC over the fertilization rate was significant, depicting an inverted U-shaped curve: with up to approximately 10 million motile sperm, fertilization rates increased as TMC increased, but from this point on decreased. A slight increment in the rate of good embryo formation with increasing value of TMC was noted, but this did not reach a statistical significance. TMC values demonstrated no effect in the case of implantation rates. ICSI may offer an advantage related to fertilization rates for the sub-fertile male population, with a motile sperm count up to 10 million.

Introduction and Hypothesis: Our objective was to assess preoperative risk factors for developing recurrent stress urinary incontinence (SUI) following transvaginal sling incision (TVSI) for bladder outlet obstruction (BOO)., Methods: We identified 101 women who underwent TVSI and/or removal of a midurethral sling. Thirty-nine underwent TVSI for clinical and videourodynamic demonstrable BOO. Eighteen of 39 women demonstrated preoperative clinical SUI and urodynamic BOO. A comparative analysis was performed specifically looking at several clinical factors and the risk of the occurrence of postoperative SUI., Results: Mean age, number of prior surgeries, parity, and pre- and postoperative PVRs did not predict for postoperative SUI. Nine of 18 (50%) of women with SUI and BOO preoperatively vs. only 2/21 (10%) of women with BOO alone developed postoperative SUI. This difference in the incidence of postoperative SUI was statistically significant (p<0.01)., Conclusions: In patients with BOO, the presence of preoperative clinical SUI is a predictor for postoperative SUI following TVSI.

Aims: We assessed the effects of onabotulinumtoxinA (BOTOX®) on clinical and urodynamic variables in patients with idiopathic overactive bladder (OAB) and urinary urgency incontinence (UUI) with or without detrusor overactivity (DO), inadequately managed with anticholinergics., Methods: Three hundred thirteen patients with OAB were randomized to double-blind intradetrusor injection with placebo (n = 44) or 1 of 5 onabotulinumtoxinA doses (50-300 U; n = 269). Primary efficacy variable was change from baseline in UUI episodes/week at week 12. Urodynamic assessments at baseline and weeks 12 and 36 included maximum cystometric capacity (MCC) and volume at first involuntary detrusor contraction (IDC)., Results: 76.0% of patients had baseline DO. Changes from baseline in MCC and volume at first IDC with onabotulinumtoxinA ≥100 U were superior to placebo at week 12, generally decreasing by week 36. Significant dose-dependent increases in MCC were observed for all onabotulinumtoxinA doses at week 12, and for 150, 200, and 300 U at week 36. Data suggested a dose-response relationship. At week 12 on diary, 15.9% of placebo and 29.8-57.1% of onabotulinumtoxinA 50-300 U recipients, respectively, did not demonstrate UUI. OnabotulinumtoxinA doses >150 U were more commonly associated with post-void residual urine volumes >200 ml., Conclusions: Improvements in urodynamic parameters and clinical outcomes generally trended together following onabotulinumtoxinA treatment. This therapy improved key urodynamic parameters in patients with idiopathic OAB and UUI, with no differences in outcomes between those with and those without baseline DO. Therefore, successful idiopathic OAB treatment with onabotulinumtoxinA does not appear to be related to pretreatment finding of DO., (Copyright © 2011 Wiley-Liss, Inc.)

Objectives: To determine whether Zuidex using a non-cystoscopy mid-urethral injection technique produces as good a result (i.e. was not inferior) as Contigen injected endoscopically at the bladder neck in the treatment of urinary stress incontinence secondary to intrinsic sphincter deficiency in adult women., Methods: A prospective 2:1 randomized trial of mid-urethral injections of Zuidex-Implacer vs proximal urethral cystoscopic injections of Contigen was performed in 344 women with intrinsic sphincter deficiency at 23 North American sites, and followed up for >1 year from last treatment., Results: Outcomes at 12 months from last treatment failed to demonstrate that mid-urethral injected Zuidex was equivalent to cystoscopically injected Contigen in primary and secondary outcome variables. The primary outcome, the proportion of women who achieved a 50% reduction in urinary leakage on provocation testing, was achieved in 84% of Contigen-treated women vs 65% of Zuidex-treated women., Conclusions: Confounding multiple variables inherent in the study design make a detailed analysis of study outcomes difficult.

The primary pharmacological therapy for overactive bladder syndrome is muscarinic receptor antagonists. Muscarinic receptor blockade is effective in decreasing the symptoms of urinary urgency and urgency incontinence, but can be associated with troublesome complications, such as dry mouth, blurred vision, constipation and CNS side effects. Trospium chloride, an antimuscarinic medication, has been available in Europe for > 20 years and has recently been approved by the FDA for the treatment of overactive bladder. Trospium chloride is a quaternary amine that is minimally metabolised, not highly protein bound and, importantly, has not been demonstrated to cross the unaltered blood-brain barrier in healthy volunteers. Some characteristics of this unique antimuscarinic agent and the European experience with trospium chloride are reviewed in this article.

Unlabelled: Purpose/objective Long-term complications from anti-incontinence surgical procedures are rarely reported. We report on delayed presentation of complications relating to the synthetic bolster placed for the Stamey bladder neck suspension., Materials and Methods: Patients undergoing re-operative surgery following prior Stamey endoscopic bladder neck suspension were selected from a surgical database. Four women with lower urinary tract and/or vaginal symptoms following prior Stamey endoscopic bladder neck suspension were identified. All patients had undergone removal of the bolster material by a single surgeon (ESR) at re-operation. Preoperative, operative, and postoperative inpatient and outpatient records were reviewed., Results: Patients presented with a variety of symptoms including urinary incontinence, recurrent cystitis, vaginitis, and urinary frequency at 9, 11, 11, and 12 years after Stamey bladder neck suspension. In addition, two patients presented with recurrent, intermittent bloody vaginal discharge and two patients complained of recurrent urinary tract infections and irritative voiding symptoms. All patients underwent transvaginal excision of the Dacron bolster. Three patients also underwent placement of an autologous pubovaginal sling for symptomatic recurrent stress urinary incontinence. At a mean follow-up of 30 months all four patients were improved. There was no recurrence of vaginal discharge or urinary tract infections. Irritative voiding symptoms resolved., Conclusions: Delayed complications from surgically implanted synthetic materials can present many years after initial implantation. The clinical findings are often subtle and require a high degree of suspicion. Vaginal discharge and irritative urinary symptoms in patients with even a remote history of Stamey bladder neck suspension should prompt a thorough vaginal exam and cystoscopy. Excision of the bolsters can be performed and is usually followed by symptomatic improvement.

Background: Smoking restrictions provide opportunities to modify smoking behavior. A large insurance company implemented a smoke-free grounds policy at two of their office complexes in January, 2000., Methods: This cohort study evaluated the impact of the smoke-free grounds policy on abstinence among 128 employees who participated in a tobacco dependence treatment program., Results: The overall quit rate at 6 months was 44.5%. The larger complex showed a trend for higher quit rates compared to the smaller complex (46.5 vs. 28.6%). Post-ban participants had higher quit rates than pre-ban participants (52.4 vs. 43.0%). The probability of abstinence at 6 months follow-up was higher for post-ban compared to pre-ban participants (P = 0.03). Post-ban participants were 80% less likely to relapse than pre-ban participants. Non-quitters decreased their consumption by 6.6 cigarettes/day (39.1% decrease)., Conclusions: A "smoke-free grounds" policy encourages abstinence and may play a significant role in harm reduction among continuing tobacco users.

Smoking markedly increases the risk of asbestos-related lung cancer. We conducted a randomized pilot trial of a telephone-based smoking cessation intervention in asbestos workers. Fifty-nine smokers were assigned to either a control or telephone-based smoking cessation treatment group and were followed-up at 6 months. Intent-to-treat analysis revealed a 16.7% quit rate at 6 months for the intervention group compared to 6.9% for the control group (P = 0.25). Treatment-received quit-rates were 33% for the intervention group and 6.9% for the control group (P = 0.05). The intervention group was twice as likely to use smoking cessation medicines and progressed further along the stage of change continuum compared with the control group. Incorporating telephone-based smoking cessation treatment into medical screening activities for asbestos workers is feasible and the intervention is effective in increasing quit rates at 6 months.

Background: Asbestos exposure and concomitant cigarette smoking markedly increase the risk of lung cancer and contribute to the prevalence and severity of pulmonary interstitial fibrosis., Methods: A cross-sectional survey of 214 asbestos workers was initiated to determine the prevalence of smoking and their readiness to quit smoking using the stage of change theory., Results: The study was comprised of 61 never smokers (28.5%), 118 ex-smokers (55.1%), and 35 current smokers (16.4%). Reasons for smoking cessation in ex-smokers included perception of ill-health (51%) and knowledge of smoking-asbestos hazards (3.4%). Stage of change of current smokers revealed: precontemplation (26.5%), contemplation (35%), preparation (29%), and action (8.8%). Current smokers had the highest prevalence of small airway obstruction on spirometry., Conclusions: A detailed smoking history during medical surveillance activities will enable the occupational physician to identify asbestos workers who have difficulty quitting and to develop a system in which such individuals can be referred to comprehensive smoking cessation programs., (Copyright 2002 Wiley-Liss, Inc.)

Objectives: To evaluate the frequency and types of treatments reported at baseline in women who entered the Interstitial Cystitis Data Base (ICDB) cohort study., Methods: From 1993 to 1997, 581 women were enrolled and followed in the ICDB. All treatments reported at study entry, including those prescribed for interstitial cystitis (IC) and concomitant medications, were reviewed. The number and types of treatments were evaluated with respect to baseline factors such as prior diagnosis of IC and symptom severity., Results: One hundred five (18%) women were receiving no therapy at baseline. Single-mode therapy was reported by 195 (34%) women, and a combination of two treatments was reported by 119 (21%) women. Three or more treatments were reported in 162 (28%) women. A total of 183 different types of therapies were recorded. The five most commonly used therapies for IC symptoms were cystoscopy and hydrodistention, amitriptyline, phenazopyridine, special diet, and intravesical heparin. Because most patients entered the ICDB before the approval of oral pentosan polysulfate sodium (PPS), only 6% of women reported oral PPS use at baseline. There were statistically significant associations between the number and types of treatments and clinical center, a prior diagnosis of IC, and symptom severity., Conclusions: The diversity of IC therapies underscores the lack of understanding about the treatment of this syndrome. Further research in IC is essential to develop and to evaluate rational therapies and treatment algorithms. These algorithms should be "evidence based" and should be revised as the underlying etiology and pathophysiology of IC is delineated.

Purpose: We describe the technique and results of a simply constructed continence mechanism for continent urinary diversion to the skin based on the ileocecal valve., Materials and Methods: During a 3-year period 28 patients underwent construction of a continent stoma using the ileocecal valve; 23 patients were available for evaluation. The various indications for lower urinary tract reconstruction in this patient population included malignancy (4), neurogenic bladder (11), and urethral dysfunction (8). The continence mechanism is provided by the ileocecal valve, with tapering of the distal ileal segment with an absorable stapling device and then securing the catheterizable ileal segment to the serosa of the cecum along an opened taenia to provide an additional level of continence to the ileocecal valve., Results: Continence was achieved in 83% (19 of 23) of patients. Two patients required revision and are now dry, and two patients have not undergone revision and remain wet. No patients have had problems with difficult or traumatic catheterization of the limb or peristomal hernia. One case of stomal stenosis was identified and treated with an outpatient revision., Conclusions: This technique for construction of a continence mechanism for a continent cutaneous urinary reservoir is simple to create, reliable, and without excess morbidity.