Using clinical estimate or catheter measurement of urethral mid-point result in similar retropubic mid-urethral sling position: a randomized trial.

INTRODUCTION AND HYPOTHESIS: The objective was to determine whether standardized, intraoperative urethral measurement improves retropubic mid-urethral sling (RPMUS) positioning and if the intraoperative position remains stable at 2 weeks postoperatively. METHODS: Participants undergoing a RPMUS were randomized to mid-urethral placement as per usual surgical care (no Foley catheter measurement, no-FCM) vs urethral mid-point Foley catheter measurement (FCM). The primary outcomes were RPMUS location as determined by 2D and 3D ultrasound 2 weeks postoperatively (as percentage from urethral meatus - relative to the urethral length) and intraoperatively following the RPMUS placement. RESULTS: Forty-four women enrolled, underwent RPMUS, and provided baseline data and intraoperative ultrasound measurements; of these, 36 (82%) had interpretable intraoperative and postoperative ultrasound measurements. Demographic data were similar in the two groups. The mean RPMUS mid-point was 57 % and 55 % in measured and controls (p = 0.685); this same measurement was relatively unchanged at 2 weeks postoperatively at 57% and 54% respectively (p = 0.538). Very much and much improvement was reported on the PGI-I by 84% and 85% of participants in the FCM and no-FCM groups respectively. CONCLUSIONS: Intraoperative RPMUS position at 2 weeks after surgery is similar to the intraoperative position. Compared with usual surgical care, intraoperative measurement of urethral mid-point with a Foley catheter did not affect RPMUS sling position.

Does Patient Education Augment Pelvic Floor Physical Therapy Preparedness and Attendance? A Randomized Controlled Trial.

OBJECTIVES: The objective of this study was to evaluate patient attendance and preparedness for pelvic floor physical therapy (PFPT) after comparing standard counseling versus standard counseling plus an educational video. METHODS: A randomized controlled trial of 200 patients in a Female Pelvic Medicine and Reconstructive Surgery practice was performed in a tertiary care referral center. Participants were randomized to 1 of 2 educational modalities after being prescribed PFPT. Women either received standard handout counseling or enhanced video counseling. A sample size of 96 per group (N = 192) was needed to detect a 20% difference in PFPT attendance corresponding to a priori estimates of 50% compliance for the standard counseling group (handout) versus 70% compliance for the enhanced counseling group (handout plus video). Compliance data were assessed at least 3 months after the initial referral to determine attendance at PFPT. RESULTS: Sixty-five percent of patients attended at least 1 PFPT visit, whereas 46.5% completed therapy. There was no difference between the standard and enhanced counseling groups in PFPT attendance (P = 0.056) or in completion of half the recommended visits (P = 0.17). Similarly, level of preparedness after viewing the assigned counseling modality did not differ between standard and enhanced counseling groups. For each additional completed visit, the odds of successfully completing PFPT increased by approximately 38% (odds ratio, 1.38; 95% confidence interval, 1.19-1.59). CONCLUSIONS: The addition of enhanced patient counseling did not improve patient preparedness or odds of attending PFPT. Adherence behaviors surrounding PFPT attendance are multifactorial and require further qualitative research to elucidate barriers to PFPT attendance.

Urethral sensation following reconstructive pelvic surgery.

INTRODUCTION AND HYPOTHESIS: Most urethral neuromuscular function data focus on efferent rather than afferent innervation. We aimed to determine if changes exist in urethral afferent nerve function before and after reconstructive pelvic surgery (RPS). Secondarily, we compared afferent urethral innervation in women with and without stress urinary incontinence undergoing RPS. METHODS: Participants underwent current perception threshold (CPT) and urethral anal reflex (UAR) testing prior to surgery and again post-operatively. Wilcoxon signed ranked test and Spearman's correlations were used and all tests were two-sided. p = 0.05 was considered to indicate statistical significance. RESULTS: Urethral CPT thresholds increased significantly after RPS, consistent with decreased urethral afferent function. Pre-operative urethral CPT thresholds at 5 and 250 Hz were lower in SUI women (10 [IQR 5-29], 40 [32-750]) compared with continent women (63 [14-99], 73 [51-109]; p = 0.45, p = 0.020), signifying increased urethral sensation or easier activation of urethral afferents in SUI women. CONCLUSIONS: Reconstructive pelvic surgery is associated with a short-term deleterious impact on urethral afferent function, as demonstrated by the higher levels of stimuli required to activate urethral afferent nerves (decreased urethral sensation) immediately after RPS. Women with SUI required lower levels of stimuli to activate urethral afferent nerves prior to RPS, although UAR latencies were similar regardless of concomitant SUI.

Abdominal Colpopexy: Comparison of Endoscopic Surgical Strategies (ACCESS).

INTRODUCTION: Robotic assistance during laparoscopic surgery for pelvic organ prolapse rapidly disseminated across the United States without level I data to support its benefit over traditional open and laparoscopic approaches [1]. This manuscript describes design and methodology of the Abdominal Colpopexy: Comparison of Endoscopic Surgical Strategies (ACCESS) Trial. METHODS: ACCESS is a randomized comparative effectiveness trial enrolling patients at two academic teaching facilities, UCLA (Los Angeles, CA) and Loyola University (Chicago, IL). The primary aim is to compare costs of robotic assisted versus pure laparoscopic abdominal sacrocolpopexy (RASC vs LASC). Following a clinical decision for minimally-invasive abdominal sacrocolpopexy (ASC) and research consent, participants with symptomatic stage≥II pelvic organ prolapse are randomized to LASC or RASC on the day of surgery. Costs of care are based on each patient's billing record and equipment costs at each hospital. All costs associated with surgical procedure including costs for robot and initial hospitalization and any re-hospitalization in the first 6weeks are compared between groups. Secondary outcomes include post-operative pain, anatomic outcomes, symptom severity and quality of life, and adverse events. Power calculation determined that 32 women in each arm would provide 95% power to detect a $2500 difference in total charges, using a two-sided two sample t-test with a significance level of 0.05. RESULTS: Enrollment was completed in May 2011. The 12-month follow-up was completed in May 2012. CONCLUSIONS: This is a multi-center study to assess cost as a primary outcome in a comparative effectiveness trial of LASC versus RASC.

Quality of life after surgery for stress incontinence.

This study investigated changes in condition-specific quality of life (QOL) after surgery for stress urinary incontinence. Data from 655 women in a clinical trial comparing the Burch and fascial sling were examined. Improvement in QOL, measured with the Incontinence Impact Questionnaire (mean decrease 133.1; SD 109.8), was observed 6 months after surgery and persisted at 24 months. Women for whom surgery was successful (regardless of surgery type) had greater improvement in QOL (mean decrease 160.0; SD 103.9) than did women for whom surgery was not successful (mean decrease 113.6; SD 110.9; p < 0.0001), although not statistically significant after adjusting for covariates. Multivariable analysis showed that QOL improvement was related to decreased urinary incontinence (UI) symptom bother, greater improvement in UI severity, younger age, Hispanic ethnicity, and receiving Burch surgery. Among sexually active women, worsening sexual function had a negative impact on QOL. Improved QOL was explained most by UI symptom improvement.

Urodynamic prolapse reduction alters urethral pressure but not filling or pressure flow parameters.

PURPOSE: To test the hypothesis that advanced stages of pelvic organ prolapse can result in a functional obstruction of the urethra, we studied the effects of manual prolapse reduction on urodynamic and urethral electromyographic parameters in women with stage III and IV pelvic organ prolapse. MATERIALS AND METHODS: Women with advanced pelvic organ prolapse undergoing clinical multichannel urodynamics with concentric needle electromyography of the urethra were invited to participate in this institutional review board approved study. Women underwent filling cystometry and electromyography with prolapse everted and with prolapse reduced. Women were randomized to cystometry order (reduced vs everted). All subjects underwent a third study with prolapse reduction. Maximum urethral closure pressure and quantitative electromyography of the striated urethral sphincter were determined at maximum cystometric capacity. During the pressure flow study voiding parameters, including urethral electromyography quieting, were determined. The nonparametric paired sign test was used to evaluate differences in urodynamic parameters and quantitative electromyography with pelvic organ prolapse reduced and unreduced. Results were considered significant at the 5% level. RESULTS: The 31 participants had mean age of 60 years (range 36 to 78) and 83% were white. There were no clinically significant differences in maximum cystometric capacity, voided volume, maximal flow and detrusor pressure at maximal flow or time to maximal flow between the reduced and everted prolapse states. Prolapse reduction resulted in a clinically and statistically significant decrease in maximum urethral closure pressure (-31%) but it had no impact on quantitative urethral electromyography. CONCLUSIONS: These findings demonstrate that, although prolapse reduction significantly decreases maximum urethral closure pressure, it does not alter intrinsic neuromuscular activity of the striated urethral sphincter. Prolapse reduction does not alter any other filling or pressure flow parameter.