Keisha Y. Dyer

Colporrhaphy compared with mesh or graft-reinforced vaginal paravaginal repair for anterior vaginal wall prolapse: a randomized controlled trial.

OBJECTIVE: To report 2-year outcomes of a randomized controlled trial comparing standard anterior colporrhaphy with reinforced vaginal paravaginal repair using xenograft or synthetic mesh in women with symptomatic anterior vaginal wall prolapse. METHODS: Women with stage II or greater anterior prolapse were randomly assigned to three groups: anterior colporrhaphy, paravaginal repair with porcine dermis, or polypropylene mesh. Outcomes of prolapse stage, quality of life, degree of bother, and sexual symptoms were assessed by blinded examiners and validated measures at 2 years. Anatomic failure was defined as anterior prolapse at stage II or greater. Composite failure was defined as symptoms of “bulge” and anterior prolapse at stage II or greater. Power calculations determined 33 participants per arm would detect a 40% difference in anatomic success between standard and grafted repair. &khgr;2, Mann-Whitney U, and Students t tests were used for comparisons. RESULTS: Of the 99 participants enrolled, 78 (79%) completed a minimum of 2-year follow-up. Those with mesh had a significantly lower anatomic failure rate (18%) than both the porcine (46%, P=.015) and colporrhaphy groups (58%, P=.002). All groups had statistically similar reductions in their prolapse and urinary symptom subscale scores. Composite failure was not statistically different between groups: 13% colporrhaphy, 12% porcine, and 4% mesh. Two reoperations for anterior prolapse occurred in the porcine group. Mesh erosion rates were 14% for the mesh group. CONCLUSION: Vaginal paravaginal repair with polypropylene mesh has the lowest anatomic failure rate when compared with that with xenograft and anterior colporrhaphy without differences in composite failures. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT0139171. LEVEL OF EVIDENCE: I

Sexual activity and function in women more than 2 years after midurethral sling placement

OBJECTIVE The purpose of this study was to assess prospectively the effects of midurethral sling surgery on sexual function and activity. STUDY DESIGN Sexual activity and function was assessed in 597 women with stress urinary incontinence who were enrolled in a randomized equivalence trial of retropubic compared with transobturator midurethral slings. Repeated measures analysis of variance was used to assess changes in Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire scores over a 2-year period. RESULTS Significant, similar improvements in sexual function were seen in both midurethral sling groups. Mean Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire scores increased from 32.8 at baseline to 37.6 at 6 months and 37.3 at 24 months (P < .0001). Dyspareunia, incontinence during sex, and fear of incontinence during sex each significantly improved after surgery. Preoperative urge incontinence was associated with abstinence after surgery (P = .02); postoperative urge incontinence negatively impacted sexual function (P = .047). CONCLUSION Midurethral sling surgery for stress urinary incontinence significantly improves sexual function, although coexistent urge incontinence has a negative impact.

Minimum important difference for validated instruments in women with urge incontinence

Minimum important difference (MID) estimates the minimum degree of change in an instruments score that correlates with subjective sense of improvement. The aim of this study was to estimate the MID for the Urogenital Distress Inventory (UDI), Incontinence Impact Questionnaire (IIQ) and Overactive Bladder Questionnaire (OAB‐q) using anchor and distribution‐based approaches in patients with urge‐predominant incontinence and whether MID changes over time.

Minimum important differences for scales assessing symptom severity and quality of life in patients with fecal incontinence.

Objectives The objective of this study was to estimate the minimum important difference (MID) for the Fecal Incontinence Severity Index (FISI), the Colorectal-Anal Distress Inventory (CRADI) scale of the Pelvic Floor Distress Inventory, the Colorectal-Anal Impact Questionnaire (CRAIQ) scale of the Pelvic Floor Impact Questionnaire, and the Modified Manchester Health Questionnaire (MMHQ). Methods We calculated the MIDs using anchor-based and distribution-based approaches from a multicenter prospective cohort study investigating adaptive behaviors among women receiving nonsurgical and surgical management for fecal incontinence (FI). Patient responses were primarily anchored using a Global Impression of Change scale. The MID was defined as the difference in mean change from baseline between those who indicated they were “a little better” and those who reported “no change” on the Global Impression of Change scale 3 months after treatment. The effect size and SE of measurement were the distribution methods used. Results The mean changes (SD) in FISI, CRADI, CRAIQ, and MMHQ scores from baseline to 3 months after treatment were −8.8 (12.0), −52.7 (70.0), −60.6 (90.0), and −12.6 (19.2), respectively. The anchor-based MID estimates suggested by an improvement from no change to a little better were −3.6, −11.4 and −4.7, −18.1 and −8.0, and −3.2 for the FISI, CRADI (long and short version), CRAIQ (long and short version), and MMHQ, respectively. These data were supported by 2 distribution-based estimates. Conclusions The MID values for the FISI are −4, CRADI (full version, −11; short version, −5), CRAIQ (full version, −18; short version, −8), and MMHQ −3. Statistically significant improvements that meet these thresholds are likely to be clinically important.

Validation of the activities assessment scale in women undergoing pelvic reconstructive surgery.

Objective The Activities Assessment Scale (AAS) is a 13-item postoperative functional activity scale validated in men who underwent hernia surgery. We evaluated the psychometric characteristics of the AAS in women who underwent vaginal surgery for pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Methods Participants included 163 women with POP and SUI enrolled in a randomized trial comparing sacrospinous ligament fixation to uterosacral vault suspension with and without perioperative pelvic floor muscle training. Participants completed the AAS and SF-36 at baseline and 2 weeks and 6 months postoperatively. Internal reliability of the AAS was evaluated using Cronbach &agr;. Construct validity and responsiveness were examined in cross-sectional and longitudinal data using Pearson correlation coefficient and analysis of variance. The AAS is scored from zero to 100 (higher scores = better function). Results Mean (SD) baseline AAS score was 87 (17.3) (range, 25–100). Functional activity declined from baseline to 2 weeks postoperatively (mean change, −4.5; 95% confidence interval, −7.6 to −1.42) but improved above baseline at 6 months (mean change, +10.9; 95% confidence interval, 7.8–14.0). Internal reliability of the AAS was excellent (Cronbach &agr; = 0.93). Construct validity was demonstrated by a correlation of 0.59 to 0.60 between the AAS and SF-36 physical functioning scale (P < 0.0001) and lower correlations between the AAS and other SF-36 scales. Patients who improved in physical functioning based on the SF-36 between 2 weeks and 6 months postoperatively showed an effect size of 0.86 for change in the AAS over the same period. Conclusions The AAS is a valid, reliable, and responsive measure for evaluation of physical function in women after pelvic reconstructive surgery.

Validation of the surgical pain scales in women undergoing pelvic reconstructive surgery

Objective Surgical pain scales (SPS) consist of 4 items that measure pain at rest, during normal activities, and during work/exercise and quantify unpleasantness of worst pain, which are valid and responsive in men undergoing hernia repair. Our objective was to evaluate the psychometric properties of SPS in women undergoing vaginal surgery for pelvic organ prolapse and stress urinary incontinence. Methods We modified SPS by converting original response scales from a visual analog scale to numerical rating scales. Numerical rating scales have lower error rates and higher validity than visual analog scale. The sample included 169 women with stage II to IV pelvic organ prolapse and stress urinary incontinence in a randomized trial comparing sacrospinous ligament fixation to uterosacral vault suspension with and without pelvic floor muscle training. Participants completed SPS and SF-36 at baseline, and 2 weeks and 6 months after surgery. Construct validity and responsiveness were examined in cross-sectional and longitudinal data using Pearson correlation and analysis of variance. Results Pain at rest, during normal activities, and during work/exercise worsened at 2 weeks (P < 0.05); and all measures of pain improved from baseline to 6 months (P < 0.0001). Construct validity was demonstrated by correlations of 0.51 to 0.74 between SPS and the SF-36 Bodily Pain Scale (P < 0.0001). Pain worsened on SF-36 between baseline and 2 weeks in 63% of the participants, and this group demonstrated a mean (SD) increase in pain of 1.9 (2.8) on the SPS (effect size, 0.99), confirming responsiveness of the scale. Conclusions The modified SPS are valid and responsive in women after pelvic reconstructive surgery.

Controlling anal incontinence in women by performing anal exercises with biofeedback or loperamide (CAPABLe) trial: Design and methods

The goals of this trial are to determine the efficacy and safety of two treatments for women experiencing fecal incontinence. First, we aim to compare the use of loperamide to placebo and second, to compare the use of anal sphincter exercises with biofeedback to usual care. The primary outcome is the change from baseline in the St. Marks (Vaizey) Score 24weeks after treatment initiation. As a Pelvic Floor Disorders Network (PFDN) trial, subjects are enrolling from eight PFDN clinical centers across the United States. A centralized data coordinating center supervises data collection and analysis. These two first-line treatments for fecal incontinence are being investigated simultaneously using a two-by-two randomized factorial design: a medication intervention (loperamide versus placebo) and a pelvic floor strength and sensory training intervention (anal sphincter exercises with manometry-assisted biofeedback versus usual care using an educational pamphlet). Interventionists providing the anal sphincter exercise training with biofeedback have received standardized training and assessment. Symptom severity, diary, standardized anorectal manometry and health-related quality of life outcomes are assessed using validated instruments administered by researchers masked to randomized interventions. Cost effectiveness analyses will be performed using prospectively collected data on care costs and resource utilization. This article describes the rationale and design of this randomized trial, focusing on specific research concepts of interest to researchers in the field of female pelvic floor disorders and all other providers who care for patients with fecal incontinence.

Improving biofeedback for the treatment of fecal incontinence in women: Implementation of a standardized multi-site manometric biofeedback protocol

Standardized training and clinical protocols using biofeedback for the treatment of fecal incontinence (FI) are important for clinical care. Our primary aims were to develop, implement, and evaluate adherence to a standardized protocol for manometric biofeedback to treat FI.

Pelvic fracture with complete urethrovaginal complex avulsion.

BACKGROUND: The anatomic support of the urethra is controversial. We present a case of an intact urethra and vagina avulsing from the symphysis pubis after pelvic fracture. CASE: An 18-year-old female pedestrian was struck by a motor vehicle. Operative reevaluation revealed an intact vagina and urethra; however, they were avulsed from the symphysis pubis. The avulsed urethra and vagina were reapproximated to the periosteum and surrounding soft tissue circumferentially with no urogenital sequelae. CONCLUSION: Complete anterior vaginal wall avulsion may occur with sparing of the lower urinary tract in the setting of pelvic fracture. This case supports the current anatomic understanding of a strong and dense attachment between the urethra and the anterior vaginal wall.