Association Between Enlarged Genital Hiatus and Composite Surgical Failure After Vaginal Hysterectomy With Uterosacral Ligament Suspension.

IMPORTANCE: The impact of a persistently enlarged genital hiatus (GH) after vaginal hysterectomy with uterosacral ligament suspension on prolapse outcomes is currently unclear. OBJECTIVES: This secondary analysis of the Study of Uterine Prolapse Procedures Randomized trial was conducted among participants who underwent vaginal hysterectomy with uterosacral ligament suspension. We hypothesized that women with a persistently enlarged GH size would have a higher proportion of prolapse recurrence. STUDY DESIGN: Women who underwent vaginal hysterectomy with uterosacral ligament suspension as part of the Study of Uterine Prolapse Procedures Randomized trial (NCT01802281) were divided into 3 groups based on change in their preoperative to 4- to 6-week postoperative GH measurements: (1) persistently enlarged GH, 2) improved GH, or (3) stably normal GH. Baseline characteristics and 2-year surgical outcomes were compared across groups. A logistic regression model for composite surgical failure controlling for advanced anterior wall prolapse and GH group was fitted. RESULTS: This secondary analysis included 81 women. The proportion with composite surgical failure was significantly higher among those with a persistently enlarged GH (50%) compared with a stably normal GH (12%) with an unadjusted risk difference of 38% (95% confidence interval, 4%-68%). When adjusted for advanced prolapse in the anterior compartment at baseline, the odds of composite surgical failure was 6 times higher in the persistently enlarged GH group compared with the stably normal group (95% confidence interval, 1.0-37.5; P = 0.06). CONCLUSION: A persistently enlarged GH after vaginal hysterectomy with uterosacral ligament suspension for pelvic organ prolapse may be a risk factor for recurrent prolapse.

Risk factors for incomplete bladder emptying after midurethral sling.

OBJECTIVE: To describe the prevalence and risk factors for incomplete bladder emptying after midurethral slings (MUS) in a large multicenter trial. METHODS: Five hundred ninety-seven women were randomized to retropubic (RMUS) or transobturator midurethral slings as part of the Trial of MidUrethral Slings study. Demographic data and voiding symptoms were obtained preoperatively along with urodynamics. Patients underwent a standardized voiding trial at discharge after continence surgery. Incomplete bladder emptying was defined as a postvoid residual of >150 mL. RESULTS: Three-quarters of patients (454 of 597) were self-voiding at discharge, whereas 114 of 597 (19%) were managed with an indwelling urethral catheter and 29 of 597 (5%) with intermittent catheterization. At 2 weeks, only 38 of 586 (6%) reported any catheter use, and by 6 weeks, only 9 of 587 (2%) reported any catheter use. Women with incomplete bladder emptying at discharge were more likely to have had a RMUS (odds ratio 1.79; 95% confidence interval 1.22-2.62) and to report preoperative voiding accommodations such as straining to void (odds ratio 1.75; 95% confidence interval 1.04-2.96). Urodynamic and clinicodemographic parameters were not predictive of incomplete bladder emptying. CONCLUSION: Incomplete bladder emptying at discharge after MUS is common, especially after RMUS, but of short duration. Risk factors include preoperative voiding accommodations such as straining or bending over to void, but other variables including urodynamics did not predict incomplete bladder emptying after MUS.

Quantification of vaginal support: are continuous summary scores better than POPQ stage?

OBJECTIVE: This analysis compared 3 continuous variables as summary support loss (SL) scores with pelvic organ prolapse (POP) quantification (POPQ) ordinal stages. STUDY DESIGN: We used pooled baseline data from 1141 subjects in 3 randomized trials (CARE, n = 322; OPUS, n = 380; ATLAS, n = 439) to test 3 SL measures. The relative responsiveness was assessed using the standardized response mean of 2-year outcome data from the CARE trial. RESULTS: Each SL measure was strongly correlated with POPQ ordinal staging; the single most distal POPQ point had the strongest correlation. Improvements in anatomic support were weakly correlated with improvements in POP Distress Inventory (r = 0.17-0.24; P < .01 for each) but not with changes in POP Impact Questionnaire for all measures of SL or POPQ stage. CONCLUSION: While continuous, single number summary measures compared favorably to ordinal POPQ staging system, the single most distal POPQ point may be preferable to POPQ ordinal stages to summarize or compare group data.

Operations and pelvic muscle training in the management of apical support loss (OPTIMAL) trial: design and methods.

The primary aims of this trial are: 1) to compare surgical outcomes following sacrospinous ligament fixation to uterosacral vaginal vault suspension in women undergoing vaginal surgery for apical or uterine pelvic organ prolapse and stress urinary incontinence and 2) to examine the effects of a structured perioperative program consisting of behavioral techniques and pelvic floor muscle training compared to usual care. This trial is performed through the Pelvic Floor Disorders Network (PFDN), which is funded by National Institute of Child Health and Human Development. Subjects will be enrolled from hospitals associated with seven PFDN clinical centers across the United States. A centralized biostatistical coordinating center will oversee data collection and analysis. Two approaches will be investigated simultaneously using a 2x2 randomized factorial design: a surgical intervention (sacrospinous ligament fixation versus uterosacral vaginal vault suspension) and a perioperative behavioral intervention (behavioral and pelvic floor muscle training versus usual care). Surgeons have standardized essential components of each surgical procedure and have met specific standards of expertise. Providers of the behavioral intervention have undergone standardized training. Anatomic, functional, and health-related quality of life outcomes will be assessed using validated measures by researchers blinded to all randomization assignments. Cost-effectiveness analysis will be performed using prospectively collected data on health care costs and resource utilization. The primary surgical endpoint is a composite outcome defined by anatomic recurrence, recurrence of bothersome vaginal prolapse symptoms and/or retreatment and will be assessed 2 years after the index surgery. Endpoints for the behavioral intervention include both short-term (6-month) improvement in urinary symptoms and long-term (2-year) improvement in anatomic outcomes and prolapse symptoms. This article describes the rationale and design of this randomized trial, focusing on several key design features of potential interest to researchers in the field of female pelvic floor disorders and others conducting randomized surgical trials.

Risk factors for mesh/suture erosion following sacral colpopexy.

OBJECTIVE: The purpose of this study was to identify risks for mesh/suture erosions following abdominal sacral colpopexy (ASC). STUDY DESIGN: We analyzed demographic, perioperative variables, and erosion status in 322 participants in the Colpopexy and Urinary Reduction Efforts study 2 years after sacral colpopexy. RESULTS: The predominant graft used was synthetic mesh: woven polyester (Mersilene; Ethicon, Inc, Somerville, NJ) (42%) or polypropylene (48%). Twenty subjects (6%) experienced mesh/suture erosion. Unadjusted risk factors for mesh/suture erosion were expanded polytrafluroethylene (ePTFE) mesh (ePTFE 4/21 [19%] vs non-ePTFE 16/301 [5%]; odds ratio [OR], 4.2), concurrent hysterectomy (OR, 4.9), and current smoking (OR, 5.2). Of those with mesh erosion, most affected women (13/17) underwent at least 1 surgery for partial or total mesh removal. Two were completely resolved, 6 had persistent problems, and 5 were lost to follow-up. No resolution was documented in the 4 women who elected observation. CONCLUSION: Expanded PTFE mesh should not be used for sacral colpopexy. Concurrent hysterectomy and smoking are modifiable risks for mesh/suture erosion.