BACKGROUND-Midurethral slings are increasingly used for the treatment of stress incontinence, but there are limited data comparing types of slings and associated complications.

BACKGROUND Urodynamic studies are commonly performed in women before surgery for stress urinary incontinence, but there is no good evidence that they improve outcomes. METHODS We performed a multicenter, randomized, noninferiority trial involving women with uncomplicated, demonstrable stress urinary incontinence to compare outcomes after preoperative office evaluation and urodynamic tests or evaluation only. The primary outcome was treatment success at 12 months, defined as a reduction in the score on the Urogenital Distress Inventory of 70% or more and a response of “much better” or “very much better” on the Patient Global Impression of Improvement. The predetermined noninferiority margin was 11 percentage points. RESULTS A total of 630 women were randomly assigned to undergo office evaluation with urodynamic tests or evaluation only (315 per group); the proportion in whom treatment was successful was 76.9% in the urodynamic-testing group versus 77.2% in the evaluation-only group (difference, −0.3 percentage points; 95% confidence interval, −7.5 to 6.9), which was consistent with noninferiority. There were no significant between-group differences in secondary measures of incontinence severity, quality of life, patient satisfaction, rates of positive provocative stress tests, voiding dysfunction, or adverse events. Women who underwent urodynamic tests were significantly less likely to receive a diagnosis of overactive bladder and more likely to receive a diagnosis of voiding-phase dysfunction, but these changes did not lead to significant between-group differences in treatment selection or outcomes. CONCLUSIONS For women with uncomplicated, demonstrable stress urinary incontinence, preoperative office evaluation alone was not inferior to evaluation with urodynamic testing for outcomes at 1 year. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and the Eunice Kennedy Shriver National Institute of Child Health and Human Development; ClinicalTrials.gov number, NCT00803959.)

The autologous fascial sling results in a higher rate of successful treatment of stress incontinence but also greater morbidity than the Burch colposuspension. (ClinicalTrials.gov number, NCT00064662 [ClinicalTrials.gov] .).

BACKGROUND Women without stress urinary incontinence undergoing vaginal surgery for pelvicorgan prolapse are at risk for postoperative urinary incontinence. A midurethral sling may be placed at the time of prolapse repair to reduce this risk. METHODS We performed a multicenter trial involving women without symptoms of stress incontinence and with anterior prolapse (of stage 2 or higher on a Pelvic Organ Prolapse Quantification system examination) who were planning to undergo vaginal prolapse surgery. Women were randomly assigned to receive either a midurethral sling or sham incisions during surgery. One primary end point was urinary incontinence or treatment for this condition at 3 months. The second primary end point was the presence of incontinence at 12 months, allowing for subsequent treatment for incontinence. RESULTS Of the 337 women who underwent randomization, 327 (97%) completed follow-up at 1 year. At 3 months, the rate of urinary incontinence (or treatment) was 23.6% in the sling group and 49.4% in the sham group (P<0.001). At 12 months, urinary incontinence (allowing for subsequent treatment of incontinence) was present in 27.3% and 43.0% of patients in the sling and sham groups, respectively (P = 0.002). The number needed to treat with a sling to prevent one case of urinary incontinence at 12 months was 6.3. The rate of bladder perforation was higher in the sling group than in the sham group (6.7% vs. 0%), as were rates of urinary tract infection (31.0% vs. 18.3%), major bleeding complications (3.1% vs. 0%), and incomplete bladder emptying 6 weeks after surgery (3.7% vs. 0%) (P≤0.05 for all comparisons). CONCLUSIONS A prophylactic midurethral sling inserted during vaginal prolapse surgery resulted in a lower rate of urinary incontinence at 3 and 12 months but higher rates of adverse events. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health Office of Research on Women’s Health; OPUS ClinicalTrials.gov number, NCT00460434.)

II-2.

Objectives To characterize the urinary microbiota in women planning treatment for urgency urinary incontinence and to describe clinical associations with urinary symptoms, urinary tract infection and treatment outcomes. Study Design Catheterized urine samples were collected from female multi-site randomized trial participants without clinical evidence of urinary tract infection and 16S rRNA gene sequencing was used to dichotomize participants as either DNA sequence-positive or sequence-negative. Associations with demographics, urinary symptoms, urinary tract infection risk, and treatment outcomes were determined. In sequence-positive samples, microbiotas were characterized on the basis of their dominant microorganisms. Results Over half [51.1% (93/182)] of the participants’ urine samples were sequence-positive. Sequence-positive participants were younger (55.8 vs. 61.3, p=0.0007), had a higher body mass index (33.7 vs. 30.1, p=0.0009), had a higher mean baseline daily urgency urinary incontinence episodes (5.7 vs. 4.2, p<0.0001), responded better to treatment (decrease in urgency urinary incontinence episodes −4.4 vs. −3.3, p=0.0013) and were less likely to develop urinary tract infection (9% vs. 27%, p=0.0011). In sequence-positive samples, eight major bacterial clusters were identified; seven clusters were dominated by a single genus, most commonly Lactobacillus (45%) or Gardnerella (17%), but also other taxa (25%). The remaining cluster had no dominant genus (13%). Conclusions DNA sequencing confirmed urinary bacterial DNA in many women without signs of infection and with urgency urinary incontinence. Sequence status was associated with baseline urgency urinary incontinence episodes, treatment response and post-treatment urinary tract infection risk.

Although the prevalence of pelvic floor disorders in a community-dwelling population is high, age was not a significant contributor after adjustment for confounders. The high co-occurrence of pelvic floor disorders suggests that physicians seeing women seeking care for one condition should inquire about symptoms of other disorders.

Objectives-To identify risks for mesh/suture erosions following sacrocolpopexy (ASC).Study Design-We analyzed demographic, perioperative variables and erosion status in 322 participants in the Colpopexy and Urinary Reduction Efforts study two years after sacrocolpopexy.Results-The predominant graft used was synthetic mesh; Mersilene (42%) or Polypropylene (48%). Twenty subjects (6%) experienced mesh/suture erosion. Unadjusted risk factors for mesh/ Condensation Gore-Tex® mesh, concurrent hysterectomy, and current smoking are risk factors associated with mesh/suture erosion complications following sacrocolpopexy.Publisher's Disclaimer: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. NIH Public Access Author ManuscriptAm J Obstet Gynecol. Author manuscript; available in PMC 2010 April 23. NIH-PA Author ManuscriptNIH-PA Author Manuscript NIH-PA Author Manuscript suture erosion were expanded polytrafluroethylene (ePTFE) mesh (ePTFE 4/21 (19%) versus nonePFTE 16/301 (5%): 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 one 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.Conclusions-Expanded PTFE mesh should not be used for sacrocolpopexy. Concurrent hysterectomy and smoking are modifiable risks for mesh/suture erosion.