Background: Although the vaginal and urinary microbiomes have been increasingly wellcharacterized in health and disease, few have described the relationship between these neighboring environments. Elucidating this relationship has implications for understanding how manipulation of the vaginal microbiome may affect the urinary microbiome and treatment of common urinary conditions.Objective: To describe the relationship between urinary and vaginal microbiomes using 16S rRNA gene sequencing. We hypothesized that the composition of the urinary and vaginal microbiomes would be significantly associated, with similarities in predominant taxa.Study Design: This multicenter study collected vaginal swabs and catheterized urine samples from 186 women with mixed urinary incontinence (MUI) enrolled in a parent study and 84 similarly aged controls. Investigators decided a priori that if vaginal and/or urinary microbiomes differed between continent and incontinent women, the groups would be analyzed separately; if similar, samples from continent and incontinent women would be pooled and analyzed together. A central laboratory sequenced variable regions 1-3 (v1-3) and characterized bacteria to the genus level. Operational taxonomic unit (OTU) abundance was described for paired vaginal and urine samples. Pearson's correlation characterized the relationship between individual OTUs of paired samples. Canonical Correlation Analysis (CCA) evaluated the association between clinical variables (including MUI and control status) and vaginal and urinary OTUs, using the CCA function in the Vegan package (R version 3.5). Linear discriminant analysis effect size (LEfSe) was used to find taxa that discriminated between vaginal and urinary samples.Results: Urinary and vaginal samples were collected from 212 women [mean age 53 (±11 years)] and results from 197-paired samples were available for analysis. As OTUs in MUI and control samples were related in CCA and since taxa did not discriminate between MUI or controls in either vagina or urine, MUI and control samples were pooled for further analysis. CCA of vaginal and urinary samples indicated that that 60 of the 100 most abundant OTUs in the samples largely overlapped. Lactobacillus was the most abundant genus in both urine and vagina (contributing on average 53% to an individual's urine sample and 64% to an individual's vaginal sample) (Pearson correlation r=0.53). Though less abundant than Lactobacillus, other bacteria with high Pearson correlation coefficients also commonly found in vagina and urine included: Gardnerella (r=0.70), Prevotella (r=0.64), and Ureaplasma (r=0.50). LEfSe analysis identified Tepidomonas and Flavobacterium as bacteria that distinguished the urinary environment for both MUI and controls as these bacteria were absent in the vagina (Tepidimonas effect size 2.38, p<0.001, Flavobacterium effect size 2.15, p<0.001). Though Lactobacillus was the most abundant bacteria in both urine and vagina, it was more abundant in the vagina (LEfSe effect size 2.72, p<0.001).Conclusion...

Introduction & Hypothesis Previous studies have suggested that women with urinary incontinence have an altered urinary microbiome. We hypothesized that the microbiome in women with mixed urinary incontinence (MUI) differed from controls and tested this hypothesis using bacterial gene sequencing techniques. Methods This multicenter study compared the urinary microbiome in women with MUI and similarly aged controls. Catheterized urine samples were obtained; v4–6 regions of the 16S rRNA gene were sequenced to identify bacteria. Bacterial predominance (> 50% of an individual’s genera) was compared between MUI and controls. Bacterial sequences were categorized into “community-types” using Dirichlet multinomial mixture (DMM) methods. Generalized linear mixed models predicted MUI/control status based on clinical characteristics and community-type. Post-hoc analyses were performed in women <51 and ≥51 years. Sample size estimates required 200 samples to detect a 20% difference in Lactobacillus predominance with P<.05. Results Of 212 samples, 97.6% were analyzed (123 MUI/84 controls, mean age 53±11 years). Overall Lactobacillus predominance did not differ between MUI and controls (45/123=36.6% vs. 36/84=42.9%, P=0.36). DMM analyses revealed six community-types; communities differed by age (P=0.001). A High-Lactobacillus (89.2% Lactobacillus) community had a greater proportion of controls (19/84=22.6%, MUI 11/123=8.9%). Overall, bacterial community-types did not differ in MUI and controls. However, post-hoc analysis of women <51 years found that bacterial community-types distinguished MUI from controls (P=0.041); Moderate-Lactobacillus (aOR 7.78, CI 1.85–32.62) and Mixed (aOR 7.10, CI 1.32–38.10) community-types were associated with MUI. Community-types did not differentiate MUI and controls in women ≥51 years (P=0.94). Conclusions Women with MUI and controls did not differ in overall Lactobacillus predominance. In younger women, urinary bacterial community-types differentiated MUI from controls.

IMPORTANCE Vaginal hysterectomy with suture apical suspension is commonly performed for uterovaginal prolapse. Transvaginal mesh hysteropexy is an alternative option. OBJECTIVE To compare the efficacy and adverse events of vaginal hysterectomy with suture apical suspension and transvaginal mesh hysteropexy. DESIGN, SETTING, PARTICIPANTS At 9 clinical sites in the US Pelvic Floor Disorders Network, 183 postmenopausal women with symptomatic uterovaginal prolapse were enrolled in a randomized superiority clinical trial between April 2013 and February 2015. The study was designed for primary analysis when the last randomized participant reached 3 years of follow-up in February 2018. INTERVENTIONS Ninety-three women were randomized to undergo vaginal mesh hysteropexy and 90 were randomized to undergo vaginal hysterectomy with uterosacral ligament suspension. MAIN OUTCOMES AND MEASURES The primary treatment failure composite outcome (re-treatment of prolapse, prolapse beyond the hymen, or prolapse symptoms) was evaluated with survival models. Secondary outcomes included operative outcomes and adverse events, and were evaluated with longitudinal models or contingency tables as appropriate. RESULTS A total of 183 participants (mean age, 66 years) were randomized, 175 were included in the trial, and 169 (97%) completed the 3-year follow-up. The primary outcome was not significantly different among women who underwent hysteropexy vs hysterectomy through 48 months (adjusted hazard ratio, 0.62 [95% CI, 0.38-1.02]; P = .06; 36-month adjusted failure incidence, 26% vs 38%). Mean (SD) operative time was lower in the hysteropexy group vs the hysterectomy group (111.5 [39.7] min vs 156.7 [43.9] min; difference, −45.2 [95% CI, −57.7 to −32.7]; P = <.001). Adverse events in the hysteropexy vs hysterectomy groups included mesh exposure (8% vs 0%), ureteral kinking managed intraoperatively (0% vs 7%), granulation tissue after 12 weeks (1% vs 11%), and suture exposure after 12 weeks (3% vs 21%). CONCLUSIONS AND RELEVANCE Among women with symptomatic uterovaginal prolapse undergoing vaginal surgery, vaginal mesh hysteropexy compared with vaginal hysterectomy with uterosacral ligament suspension did not result in a significantly lower rate of the composite prolapse outcome after 3 years. However, imprecision in study results precludes a definitive conclusion, and further research is needed to assess whether vaginal mesh hysteropexy is more effective than vaginal hysterectomy with uterosacral ligament suspension.

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IMPORTANCE Mixed urinary incontinence, including both stress and urgency incontinence, has adverse effects on a woman's quality of life. Studies evaluating treatments to simultaneously improve both components are lacking. OBJECTIVE To determine whether combining behavioral and pelvic floor muscle therapy with midurethral sling is more effective than sling alone for improving mixed urinary incontinence symptoms. DESIGN, SETTING, AND PARTICIPANTS Randomized clinical trial involving women 21 years or older with moderate or severe stress and urgency urinary incontinence symptoms for at least 3 months, and at least 1 stress and 1 urgency incontinence episode on a 3-day bladder diary. The trial was conducted across 9 sites in the United States, enrollment between October 2013 and April 2016; final follow-up October 2017. INTERVENTIONS Behavioral and pelvic floor muscle therapy (included 1 preoperative and 5 postoperative sessions through 6 months) combined with midurethral sling (n = 209) vs sling alone (n = 207). MAIN OUTCOMES AND MEASURES The primary outcome was change between baseline and 12 months in mixed incontinence symptoms measured by the Urogenital Distress Inventory (UDI) long form; range, 0 to 300 points; minimal clinically important difference, 35 points, with higher scores indicating worse symptoms. RESULTS Among 480 women randomized (mean [SD] age, 54.0 years [10.7]), 464 were eligible and 416 (86.7%) had postbaseline outcome data and were included in primary analyses. The UDI score in the combined group significantly decreased from 178.0 points at baseline to 30.7 points at 12 months, adjusted mean change −128.1 points (95% CI, −146.5 to −109.8). The UDI score in the sling-only group significantly decreased from 176.8 to 34.5 points, adjusted mean change −114.7 points (95% CI, −133.3 to −96.2). The model-estimated between-group difference (−13.4 points; 95% CI, −25.9 to −1.0; P = .04) did not meet the minimal clinically important difference threshold. Related and unrelated serious adverse events occurred in 10.2% of the participants (8.7% combined and 11.8% sling only). CONCLUSIONS AND RELEVANCE Among women with mixed urinary incontinence, behavioral and pelvic floor muscle therapy combined with midurethral sling surgery compared with surgery alone resulted in a small statistically significant difference in urinary incontinence symptoms at 12 months that did not meet the prespecified threshold for clinical importance.

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ClinicalTrials.gov, NCT02449915.