Jeffrey Mangel

Results of a Prospective, Randomized, Multicenter Study Evaluating Sacral Neuromodulation With InterStim Therapy Compared to Standard Medical Therapy at 6-Months in Subjects With Mild Symptoms of Overactive Bladder

This prospective, randomized, multicenter trial evaluated the 6‐month success rate of sacral neuromodulation (SNM) with InterStim® Therapy versus standard medical therapy (SMT) for overactive bladder (OAB).

Three-year Follow-up Results of a Prospective, Multicenter Study in Overactive Bladder Subjects Treated With Sacral Neuromodulation

OBJECTIVE To evaluate the therapeutic success rate, and changes in quality of life (QOL) and safety in subjects using sacral neuromodulation (InterStim System) at 36 months. Subjects with bothersome symptoms of overactive bladder (OAB) including urinary urge incontinence (UI) and/or urgency frequency (UF), who had failed at least 1 anticholinergic medication, and had at least 1 untried medication were included. METHODS Subjects with successful test stimulation received an InterStim implant. Therapeutic success and quality of life through 36 months was evaluated in implanted subjects with data at baseline and follow-up. Safety was evaluated using reported adverse events. RESULTS A total of 340 subjects received test stimulation resulting in 272 implanted subjects. Demographics include 91% female, mean age of 57 years, and baseline symptom severity of 3.1 ± 2.7 leaks/day (UI) and 12.6 ± 4.5 voids/day (UF). The analysis showed an OAB therapeutic success rate of 83% (95% confidence interval: 78%-88%). UI subjects had a mean reduction from baseline of 2.3 ± 2.3 leaks/day whereas UF subjects had a mean reduction of 5.3 ± 4.0 voids/day (both P < .0001). Statistically significant improvements were observed in all measures of the International Consultation on Incontinence Modular Questionnaire-OABqol (all P < .0001). Eighty percent of subjects reported improvements in their urinary symptom interference. Device-related adverse events occurred in 47% (127/272) of subjects post-implant; 91% were resolved at the time of this analysis. CONCLUSION The 36-month follow-up data from the multicenter study demonstrate sustained safety, effectiveness, and improved QOL in subjects implanted with InterStim, without requiring failure of all medications.

Results of a prospective, multicenter study evaluating quality of life, safety, and efficacy of sacral neuromodulation at twelve months in subjects with symptoms of overactive bladder

This prospective, multicenter post‐approval study evaluated the success rate of sacral neuromodulation (SNM) with the InterStim® System at 12‐months. Subjects with bothersome symptoms of overactive bladder (OAB) including urinary urge incontinence (UI) or urgency‐frequency (UF), who failed at least one anticholinergic medication and had at least one not tried were included.

Objective structured assessment of technical skills for repair of fourth-degree perineal lacerations

OBJECTIVE The objective of this study was to assess the reliability and validity of an objective structured assessment of technical skills (OSATS) for repair of fourth-degree obstetric lacerations on a surgical model. STUDY DESIGN Three blinded judges reviewed recordings of 20 junior and 20 senior obstetrics-gynecology residents performing simulated perineal repairs using a beef tongue model. Judges completed task-specific OSATS and global rating scales for each repair. Six recordings were rereviewed after 2 weeks. Inter- and intrarater reliability and construct validity were assessed. RESULTS Interrater reliability was 0.80 for task-specific OSATS and 0.59 for the global rating scale. Intrarater reliability was poor. Construct validity was demonstrated, with senior residents scoring higher than junior residents on task-specific OSATS (13.0 vs 10.5; P = .007) and the global rating scale (24.0 vs 19.3; P = .001). CONCLUSION We found good interrater reliability and construct validity using a task-specific OSATS for fourth-degree perineal laceration repair. This instrument shows promise as a tool for competency-based evaluations.

Five-Year Followup Results of a Prospective, Multicenter Study of Patients with Overactive Bladder Treated with Sacral Neuromodulation

Purpose We evaluated the therapeutic success rate, changes in quality of life and safety of sacral neuromodulation 5 years after InterStim™ implantation. Included in study were subjects with bothersome symptoms of overactive bladder, including urinary urge incontinence and/or urgency‐frequency, in whom at least 1 anticholinergic medication failed and 1 medication had not been tried. Materials and Methods Therapeutic success was defined as a urinary urge incontinence or urgency‐frequency response of 50% or greater improvement in average leaks or voids per day, or return to normal voiding, defined as fewer than 8 voids per day. Quality of life was evaluated by ICIQ‐OABqol (International Consultation on Incontinence Modular Questionnaire). Safety was evaluated through adverse events. Results Of the 340 subjects who completed the test stimulation 272 had an implant, of whom 91% were female. Mean age was 57 years. At baseline 202 subjects with urinary urge incontinence had a mean ± SD of 3.1 ± 2.7 leaks per day and 189 with urgency‐frequency had a mean of 12.6 ± 4.5 voids per day. The 5‐year therapeutic success rate was 67% (95% CI 60–74) using modified completers analysis and 82% (95% CI 76–88) using completers analysis. Subjects with urinary urge incontinence had a mean reduction from baseline of 2.0 ± 2.2 leaks per day and subjects with urgency‐frequency had a mean reduction of 5.4 ± 4.3 voids per day (each completers analysis p <0.0001). Subjects showed improvement in all ICIQ‐OABqol measures (p <0.0001). The most common device related adverse events were an undesirable change in stimulation in 60 of the 272 subjects (22%), implant site pain in 40 (15%) and therapeutic product ineffectiveness in 36 (13%). Conclusions This multicenter study shows that sacral neuromodulation had sustained efficacy and quality of life improvements, and an acceptable safety profile through 5 years in subjects with overactive bladder.

LeFort colpocleisis: a step-by-step simulation video for Female Pelvic Surgeons

Introduction and hypothesisLeFort colpocleisis is a minimally invasive surgical option for patients with pelvic organ prolapse who no longer desire sexual activity. Pelvic surgeons have limited exposure to this procedure during their training, and are therefore less likely to offer this procedure to their patients.MethodsWe use a split screen live action surgery, side by side with a low cost 3D model of a prolapse to describe a LeFort colpocleisis step by step.ResultsThis video is an easily reproducible guide to the steps and surgical techniques necessary to successfully perform a LeFort colpocleisis. The simulation model can be used to educate and train those performing female pelvic surgery.ConclusionPelvic surgeons should be able to offer LeFort colpocleisis to their patients. This video may be used to facilitate the understanding and reproducibility of the procedure.

National survey of urogynecological practice patterns among United States OB/GYN oral board examinees in different practice settings

Introduction and hypothesisThe current urogynecological surgical experience of recent OB/GYN graduates in different practice settings is unclear. The aim of this study was to evaluate differences in urogynecological surgical care between private practitioners (PPs) and other generalist OB/GYN oral board examinees.MethodsA total of 699 OB/GYN oral board examination examinees were administered a survey during board preparatory courses with a 70.7% response rate. The primary outcome was to determine differences in subjective reported performance of urogynecological surgery with and without apical support procedures (female pelvic medicine and reconstructive surgery, FPMRS, ± apical) between PP and generalists in other practice models (academic, managed care, other). Secondary outcomes included urogynecological case list reporting, referral patterns, and residency training.ResultsA total of 473 surveys were completed; after excluding subspecialists, 210 surveys were completed by PP and 162 by individuals in other settings. 6.7% of PPs subjectively reported that they perform FPMRS + apical surgery compared with 4.3% of those in other practice settings (p = 0.33). Although 29.2% of PPs reported adequate FPMRS training in residency compared with 39.7% of those in other practice settings (p = 0.04), 53.6% of PPs reported that they refer patients with pelvic organ prolapse (POP), compared with 66.5% of those in other practice settings (p = 0.013). 38.9% of PPs report that they performed POP surgery compared with 27.8% of non-PPs (p = 0.014).ConclusionsRegardless of practice setting, surgical volumes are low and few general OB/GYN board examinees report that they perform comprehensive FPMRS ± apical support surgery. The practice environment may affect providers’ management of patients with pelvic floor disorders.

Clean intermittent catheterization rates after initial and subsequent treatments with onabotulinumtoxinA for non-neurogenic overactive bladder in real-world clinical settings

Abstract Objective: Previous randomized controlled trials have reported a 6.1–6.9% incidence of clean intermittent catheterization (CIC) following treatment with onabotulinumtoxinA in non-neurogenic overactive bladder (OAB) patients who were inadequately managed by ≥1 anticholinergic. A multi-center retrospective chart review assessed the real-world rate of voiding dysfunction requiring catheterization. Methods: Patients received onabotulinumtoxinA 100 U (approved dose) administered by experienced injectors between January 2013 and June 2015. Patients using CIC or an indwelling catheter for ≥24 hours for voiding dysfunction prior to onabotulinumtoxinA injections were excluded. The primary outcome was post-treatment CIC (lasting >24 hours; per individual physician’s clinical judgment considering patient’s voiding symptoms, post-void residual [PVR] urine volumes and patient bother). Potential baseline predictors of CIC (history of pelvic prolapse, cystocele, diabetes, PVR urine volume and age) were assessed using multivariable logistic regression. Results: Overall, 299 patients received their first treatment with onabotulinumtoxinA 100 U. Mean age was 66.4 years; 98.3% were female. The incidence of CIC was 2.7% in the total study population after the first treatment with onabotulinumtoxinA. The de novo CIC rate in treatments 2 and 3 combined was similarly low (3.2%). None of the evaluated baseline characteristics were significant predictors of CIC initiation due to the low CIC incidence. Conclusions: This real-world study of non-neurogenic OAB patients treated with onabotulinumtoxinA suggests that the CIC rate is lower than the rates reported in previous studies. There were no significant correlations between baseline predictors and CIC initiation, although statistical significance may not have been reached because of the low incidence of CIC.

PD26-02 THE EFFECT OF SACRAL NEUROMODULATION ON COMPLETE CONTINENCE AT 5 YEARS FOR SUBJECTS WITH URINARY INCONTINENCE

compression. The buckling experiment showed different patterns of deformity (Figure 2). CONCLUSIONS: Data suggests that these prostheses exhibit significant physical differences. The clinical impact of these differences is poorly elucidated. These variations in the prostheses behaviors could be considered by the physician and the patient while objectively assessing the choice of the prosthesis. These findings could aid in objective patient counseling.

A Randomized Comparative Study Evaluating Various Cough Stress Tests and 24-Hour Pad Test with Urodynamics in the Diagnosis of Stress Urinary Incontinence

Purpose: The cough stress test is a common and accepted tool to evaluate stress urinary incontinence but there is no agreement on how the test should be performed. We assessed the diagnostic ability of different cough stress tests performed when varying patient position and bladder volume using urodynamic stress urinary incontinence as the gold standard. The 24‐hour pad test was also evaluated. Materials and Methods: We recruited women who presented to specialty outpatient clinics with the complaint of urinary incontinence and who were recommended to undergo urodynamic testing. A total of 140 patients were randomized to 4 cough stress test groups, including group 1—a comfortably full bladder, group 2—an empty bladder, group 3— a bladder infused with 200 cc saline and group 4—a bladder filled to half functional capacity. The sequence of standing and sitting was randomly assigned. The groups were compared by 1‐way ANOVA or the generalized Fisher exact test. The &kgr; statistic was used to evaluate agreement between the sitting and standing positions. The 95% CIs of sensitivity and specificity were calculated using the Wilson method. ROC analysis was done to evaluate the performance of the 24‐hour pad test. Results: The cough stress test performed with a bladder filled to half functional capacity was the best performing test with 83% sensitivity and 90% specificity. There was no statistically significant evidence that the sensitivity or specificity of 1 cough stress test differed from that of the others. The pad test had no significant predictive ability to diagnose urodynamic stress urinary incontinence (AUC 0.60, p = 0.08). Conclusions: Cough stress tests were accurate to diagnose urodynamic stress urinary incontinence. The 24‐hour pad test was not predictive of urodynamic stress urinary incontinence and not helpful when used in conjunction with the cough stress test.