No abstract

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

IMPORTANCE Over 300,000 surgeries are performed annually in the United States for pelvic organ prolapse. Sacrospinous ligament fixation (SSLF) and uterosacral ligament suspension (ULS) are commonly performed transvaginal surgeries to correct apical prolapse. Little is known about their comparative efficacy and safety, and it is unknown whether perioperative behavioral therapy with pelvic floor muscle training (BPMT) improves outcomes of prolapse surgery. OBJECTIVE To compare outcomes between 1) SSLF and ULS and 2) perioperative BPMT and usual perioperative care in women undergoing surgery for vaginal prolapse and stress urinary incontinence. DESIGN, SETTING AND PARTICIPANTS Multi-center, 2×2 factorial randomized trial of 374 women undergoing surgery to treat both apical vaginal prolapse and stress urinary incontinence was conducted between 2008 and 2013 at 9 U.S. medical centers. Two-year follow-up rate was 84.5%. INTERVENTIONS Surgical intervention: Transvaginal surgery including mid-urethral sling with randomization to SSLF (n = 186) or ULS (n=188); Behavioral intervention: Randomization to perioperative BPMT (n = 186) or usual care (n=188). MAIN OUTCOME MEASURES The primary outcome for the surgical intervention (surgical success) was defined as: 1) no apical descent greater than one-third into vaginal canal or anterior or posterior vaginal wall beyond the hymen (anatomic success); 2) no bothersome vaginal bulge symptoms and 3) no retreatment for prolapse at 2 years. For the behavioral intervention, primary outcome at 6 months was urinary symptom scores (Urinary Distress Inventory; range 0–300, higher scores worse), and primary outcomes at 2 years were prolapse symptom scores (Pelvic Organ Prolapse Distress Inventory; range 0–300, higher scores worse) and anatomic success. RESULTS At 2 years, surgical group was not significantly associated with surgical success rates [ULS 59.2% (93/154) vs. SSLF 60.5% (92/152), OR 0.9 (95% CI 0.6, 1.5)] or serious adverse event rates [ULS 16.5% (31/188) vs. SSLF 16.7% (31/186), OR 0.9 (95% CI 0.5, 1.6)]. BPMT was not associated with greater improvements in urinary scores at 6 months [treatment difference −6.7 (95% CI −19.7, 6.2)], prolapse scores at 24 months [treatment difference −8.0 (95% CI −22.1, 6.1)] or anatomic success at 24 months. CONCLUSIONS AND RELEVANCE Two years after vaginal surgery for prolapse and stress urinary incontinence, neither ULS nor SSLF was significantly superior to the other for anatomic, functional, and or adverse event outcomes. Perioperative BPMT did not improve urinary symptoms at 6 months or prolapse outcomes at 2 years.

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.)

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.