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OBJECTIVE: To identify clinical and demographic characteristics associated with prolapse recurrence by 12 months after native tissue transvaginal repair. METHODS: This was a planned secondary analysis of a randomized trial including postmenopausal participants with stage 2 or greater apical or anterior vaginal prolapse scheduled for surgical repair at three U.S. sites. Participants underwent vaginal hysterectomy (if uterus was present) and standardized uterosacral or sacrospinous ligament suspension at the surgeon's discretion. The intervention was perioperative (5 weeks or more preoperatively and 12 months postoperatively) vaginal estrogen compared with placebo cream. The primary outcome was time to failure by 12 months after surgery, defined by objective prolapse of the anterior or posterior walls beyond the hymen or the apex descending more than one-third of the vaginal length, symptomatic vaginal bulge, or retreatment. For this analysis, participants were grouped according to failure compared with success, and multiple factors were compared, including age, time since menopause, race and ethnicity, parity, body mass index (BMI), baseline genital hiatus measurement, prolapse stage and point of maximal prolapse, surgery type (uterosac-ral or sacrospinous ligament suspension), and concomitant procedures. Factors were assessed for association with the hazard of surgical failure using Cox proportional hazards models, adjusted for site and treatment group. Factors with PC.50 from this analysis were considered for inclusion in the final multivariable model; site and treatment group were kept in this model. RESULTS: One hundred eighty-six participants underwent surgery;183 provided complete data. There were 30 failures (16.4%) and 153 successes (83.4%) at 12 months. On bivariate analysis, failure was associated with decreasing age, shorter duration since menopause, Latina ethnicity, and greater baseline genital hiatus. In the final multivariable model, which included age, BMI, and point of maximal prolapse, only age remained significantly associated with surgical failure (adjusted hazard ratio [per year] 0.92, 95% CI, 0.860.98, P=.016). CONCLUSION: Among postmenopausal women, younger age was associated with increased frequency of prolapse recurrence by 12 months after native tissue repair. [ABSTRACT FROM AUTHOR]

Key Points: Question: Does perioperative application of intravaginal estrogen cream in postmenopausal women undergoing a standardized native tissue apical vaginal prolapse repair reduce prolapse recurrence? Findings: In this randomized clinical trial that included 186 participants with symptomatic anterior/apical vaginal prolapse, there was no statistically significant difference in the composite measure of treatment failure 12 months after the operation in those using vaginal estrogen cream before and after surgery compared with placebo (adjusted hazard ratio, 1.97). Meaning: Perioperative vaginal estrogen application does not reduce prolapse recurrence rates after native tissue transvaginal repair. Importance: Surgical repairs of apical/uterovaginal prolapse are commonly performed using native tissue pelvic ligaments as the point of attachment for the vaginal cuff after a hysterectomy. Clinicians may recommend vaginal estrogen in an effort to reduce prolapse recurrence, but the effects of intravaginal estrogen on surgical prolapse management are uncertain. Objective: To compare the efficacy of perioperative vaginal estrogen vs placebo cream on prolapse recurrence following native tissue surgical prolapse repair. Design, Setting, and Participants: This randomized superiority clinical trial was conducted at 3 tertiary US clinical sites (Texas, Alabama, Rhode Island). Postmenopausal women (N = 206) with bothersome anterior and apical vaginal prolapse interested in surgical repair were enrolled in urogynecology clinics between December 2016 and February 2020. Interventions: The intervention was 1 g of conjugated estrogen cream (0.625 mg/g) or placebo, inserted vaginally nightly for 2 weeks and then twice weekly to complete at least 5 weeks of application preoperatively; this continued twice weekly for 12 months postoperatively. Participants underwent a vaginal hysterectomy (if uterus present) and standardized apical fixation (either uterosacral or sacrospinous ligament fixation). Main Outcomes and Measures: The primary outcome was time to failure of prolapse repair by 12 months after surgery defined by at least 1 of the following 3 outcomes: anatomical/objective prolapse of the anterior or posterior walls beyond the hymen or the apex descending more than one-third of the vaginal length, subjective vaginal bulge symptoms, or repeated prolapse treatment. Secondary outcomes included measures of urinary and sexual function, symptoms and signs of urogenital atrophy, and adverse events. Results: Of 206 postmenopausal women, 199 were randomized and 186 underwent surgery. The mean (SD) age of participants was 65 (6.7) years. The primary outcome was not significantly different for women receiving vaginal estrogen vs placebo through 12 months: 12-month failure incidence of 19% (n = 20) for vaginal estrogen vs 9% (n = 10) for placebo (adjusted hazard ratio, 1.97 [95% CI, 0.92-4.22]), with the anatomic recurrence component being most common, rather than vaginal bulge symptoms or prolapse repeated treatment. Masked surgeon assessment of vaginal tissue quality and estrogenization was significantly better in the vaginal estrogen group at the time of the operation. In the subset of participants with at least moderately bothersome vaginal atrophy symptoms at baseline (n = 109), the vaginal atrophy score for most bothersome symptom was significantly better at 12 months with vaginal estrogen. Conclusions and Relevance: Adjunctive perioperative vaginal estrogen application did not improve surgical success rates after native tissue transvaginal prolapse repair. Trial Registration: ClinicalTrials.gov Identifier: NCT02431897 This randomized clinical superiority trial compares the efficacy of perioperative vaginal estrogen vs placebo cream on native tissue prolapse surgery outcomes. [ABSTRACT FROM AUTHOR]

INTRODUCTION: To determine whether percutaneous tibial nerve stimulation (PTNS) is superior to sham stimulation for the treatment of fecal incontinence (FI) in women refractory to first-line treatments. METHODS: Women aged 18 years or older with >=3 months of moderate-to-severe FI that persisted after a 4-week run-in phase were randomized 2:1 (PTNS:sham stimulation) to 12 weekly 30-minute sessions in this multicenter, single-masked, controlled superiority trial. The primary outcome was change from baseline FI severity measured by St. Mark score after 12 weeks of treatment (range 0-24; minimal important difference, 3-5 points). The secondary outcomes included electronic bowel diary events and quality of life. The groups were compared using an adjusted general linear mixed model. RESULTS: Of 199 women who entered the run-in period, 166 (of 170 eligible) were randomized, (111 in PTNS group and 55 in sham group); the mean (SD) age was 63.6 (11.6) years; baseline St. Mark score was 17.4 (2.7); and recording was 6.6 (5.5) FI episodes per week. There was no difference in improvement from baseline in St. Mark scores in the PTNS group when compared with the sham group (-5.3 vs -3.9 points, adjusted difference [95% confidence interval] -1.3 [-2.8 to 0.2]). The groups did not differ in reduction in weekly FI episodes (-2.1 vs -1.9 episodes, adjusted difference [95% confidence interval] -0.26 [-1.85 to 1.33]). Condition-specific quality of life measures did not indicate a benefit of PTNS over sham stimulation. Serious adverse events occurred in 4% of each group. DISCUSSION: Although symptom reduction after 12 weeks of PTNS met a threshold of clinical importance, it did not differ from sham stimulation. These data do not support the use of PTNS as conducted for the treatment of FI in women. [ABSTRACT FROM AUTHOR]

Objective: To evaluate characteristics associated with treatment failure 1 year after midurethral sling in women with mixed urinary incontinence.Methods: Four-hundred three women who participated in a randomized trial that compared midurethral sling and behavioral and pelvic floor muscle therapy (combined group) compared with midurethral sling alone for mixed incontinence with 1-year follow-up data were eligible for this planned secondary analysis. Overall treatment failure was defined as meeting criteria for subjective or objective failure or both. Subjective failure was defined as not meeting the minimal clinical important difference for improvement on the UDI (Urogenital Distress Inventory) total score (26.1 points). Objective failure was defined as not achieving 70% improvement on mean incontinence episodes of any type per day or having undergone any additional treatment for persistent urinary symptoms at 12 months postoperative. Logistic regression models for treatment failure were constructed. Independent variables included site and treatment group, and clinical and demographic variables based on bivariate comparisons (P<.2). Treatment group interaction effects were evaluated.Results: One hundred twelve of 379 (29.6%) women had overall treatment failure, with 56 of 379 (14.7%) undergoing additional treatment but only two needing intervention for stress incontinence. Previous overactive bladder (OAB) medication (unadjusted odds ratio [OR] 2.19, adjusted odds ratio [aOR] 1.96, 95% CI 1.17-3.31); detrusor overactivity on cystometrogram (OR 2.25, aOR 2.82, 95% CI 1.60-4.97); and higher volume at first urge (OR 1.03, aOR 1.04, 95% CI 1.01-1.07) were associated with overall failure. Worse UDI-urgency scores were associated with failure, with an added interaction effect in the midurethral sling-alone group.Conclusions: Certain clinical and urodynamic variables are associated with treatment failure after midurethral sling in women with mixed urinary incontinence. Women with more severe urgency symptoms at baseline may benefit from perioperative behavioral and pelvic floor muscle therapy combined with midurethral sling. Overall, the need for additional urinary treatment was low and primarily for OAB.Clinical Trial Registration: ClinicalTrials.gov, NCT01959347. [ABSTRACT FROM AUTHOR]

Objective: To evaluate characteristics associated with treatment failure 1 year after midurethral sling in women with mixed urinary incontinence.Methods: Four hundred three women who participated in a randomized trial that compared midurethral sling and behavioral and pelvic floor muscle therapy (combined group) against midurethral sling alone for mixed incontinence with 1 year of follow-up data were eligible for this planned secondary analysis. Overall treatment failure was defined as meeting criteria for subjective failure, objective failure, or both. Subjective failure was defined as not meeting the minimal clinically important difference for improvement on the UDI (Urogenital Distress Inventory)-total score (26.1 points). Objective failure was not achieving 70% improvement on mean incontinence episodes of any type per day or having undergone any additional treatment for urinary symptoms at 12 months postoperative. Logistic regression models for treatment failure were constructed. Independent variables included site and treatment group, and clinical and demographic variables based on bivariate comparisons (P<.2). Treatment group interaction effects were evaluated.Results: Previous overactive bladder medication use (unadjusted odds ratio [OR] 2.19, adjusted odds ratio [aOR] 1.89, 95% CI 1.10-3.25), detrusor overactivity on cystometrogram (OR 2.25, aOR 2.72, 95% CI 1.53-4.84), body mass index (OR 1.29, aOR 1.27, 95% CI 1.03-1.57), and Valsalva leak point pressure less than 60 cm H2O (OR 1.96, aOR 3.13, 95% CI 1.65-5.94) were associated with overall failure. Worse UDI urgency scores were associated with failure in the midurethral sling-alone group. Sling type (retropubic vs transobturator) was not associated with failure.Conclusion: Certain clinical and urodynamic variables are associated with treatment failure after midurethral sling among women with mixed urinary incontinence. Women with more severe urgency symptoms at baseline may benefit from perioperative behavioral and pelvic floor muscle therapy combined with midurethral sling. This information is helpful for counseling women with mixed incontinence who are considering surgery.Clinical Trial Registration: ClinicalTrials.gov, NCT01959347. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To identify baseline clinical and demographic characteristics associated with clinically important treatment responses in a randomized trial of nonsurgical therapies for fecal incontinence (FI). METHODS: Women (N = 296) with FI were randomized to loperamide or placebo- and manometry-assisted biofeedback exercises or educational pamphlet in a 2 x 2 factorial design. Treatment response was defined in 3 ways from baseline to 24 weeks: minimal clinically important difference (MID) of -5 points in St. Mark's score, >=50% reduction in FI episodes, and combined St. Mark's MID and >=50% reduction FI episodes. Multivariable logistic regression models included baseline characteristics and treatment groups with and without controlling for drug and exercise adherence. RESULTS: Treatment response defined by St. Mark's MID was associated with higher symptom severity (adjusted odds ratio [aOR] 1.20, 95% confidence interval [CI] 1.11-1.28) and being overweight vs normal/underweight (aOR 2.15, 95% CI 1.07-4.34); these predictors remained controlling for adherence. Fifty percent reduction in FI episodes was associated with the combined loperamide/biofeedback group compared with placebo/pamphlet (aOR 4.04, 95% CI 1.36-11.98), St. Mark's score in the placebo/pamphlet group (aOR 1.29, 95% CI 1.01-1.65), FI subtype of urge vs urge plus passive FI (aOR 2.39, 95% CI 1.09-5.25), and passive vs urge plus passive FI (aOR 3.26, 95% CI 1.48-7.17). Controlling for adherence, associations remained, except St. Mark's score. DISCUSSION: Higher severity of FI symptoms, being overweight, drug adherence, FI subtype, and combined biofeedback and medication treatment were associated with clinically important treatment responses. This information may assist in counseling patients, regarding efficacy and expectations of nonsurgical treatments of FI. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To identify baseline clinical and demographic characteristics associated with clinically important treatment responses in a randomized trial of nonsurgical therapies for fecal incontinence (FI). METHODS: Women (N = 296) with FI were randomized to loperamide or placebo- and manometry-assisted biofeedback exercises or educational pamphlet in a 2 x 2 factorial design. Treatment response was defined in 3 ways from baseline to 24 weeks: minimal clinically important difference (MID) of -5 points in St. Mark's score, >=50% reduction in FI episodes, and combined St. Mark's MID and >=50% reduction FI episodes. Multivariable logistic regression models included baseline characteristics and treatment groups with and without controlling for drug and exercise adherence. RESULTS: Treatment response defined by St. Mark's MID was associated with higher symptom severity (adjusted odds ratio [aOR] 1.20, 95% confidence interval [CI] 1.11-1.28) and being overweight vs normal/underweight (aOR 2.15, 95% CI 1.07-4.34); these predictors remained controlling for adherence. Fifty percent reduction in FI episodes was associated with the combined loperamide/biofeedback group compared with placebo/pamphlet (aOR 4.04, 95% CI 1.36-11.98), St. Mark's score in the placebo/pamphlet group (aOR 1.29, 95% CI 1.01-1.65), FI subtype of urge vs urge plus passive FI (aOR 2.39, 95% CI 1.09-5.25), and passive vs urge plus passive FI (aOR 3.26, 95% CI 1.48-7.17). Controlling for adherence, associations remained, except St. Mark's score. DISCUSSION: Higher severity of FI symptoms, being overweight, drug adherence, FI subtype, and combined biofeedback and medication treatment were associated with clinically important treatment responses. This information may assist in counseling patients, regarding efficacy and expectations of nonsurgical treatments of FI. [ABSTRACT FROM AUTHOR]

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 < 0.05.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. [ABSTRACT FROM AUTHOR]

This month we focus on current research in uterine conservation at the time of uterovaginal prolapse repair. Dr. Richter discusses four recent publications, which are concluded with a "bottom line" that is the take-home message. A complete reference for each can be found on on this page along with direct links to the abstracts. [ABSTRACT FROM AUTHOR]

Purpose of study To examine change in balance-related fall risk and daily functional abilities in the first 2 post-operative weeks and up to 6 weeks after gynecologic surgery. Materials and methods Prospective cohort study in gynecologic surgery patients age 65 and older. Balance confidence (Activities-specific Balance Confidence Scale) and functional status (basic and instrumental activities of daily living) were recorded pre- and post-operatively daily for 1 week and twice the second week. Physical performance balance and functional mobility were measured pre- and 1 week post-operatively using the Tinetti Fall Risk Scale, Timed Up and Go, and 6-Minute Walk test. Measures were repeated 6 weeks after surgery. Non-parametric tests for paired data were used comparing scores baseline to post-operative (POD) 7 and to POD 42. Results Median age was 72 years (range 65–88). Fall risk was elevated during the first 2 post-operative weeks, greatest on the median discharge day, POD 2 (p < 0.01). Balance performance and functional mobility at 1 week were significantly lower than baseline (p < 0.01). Functional abilities declined, including new dependence in medication management at home in 22% of these independent and cognitively intact women. Conclusions After gynecologic surgery, older women’s fall risk is highest on POD 2 and remains elevated from baseline for 2 weeks. Functional limitations in the early home recovery period include the anticipated (bathing, cooking, etc.) and some unanticipated (medication management) ones. This information may help with post-operative discharge planning. [ABSTRACT FROM AUTHOR]

Importance: Women with refractory urgency urinary incontinence are treated with sacral neuromodulation and onabotulinumtoxinA with limited comparative information.Objective: To assess whether onabotulinumtoxinA is superior to sacral neuromodulation in controlling refractory episodes of urgency urinary incontinence.Design, Setting, and Participants: Multicenter open-label randomized trial (February 2012-January 2015) at 9 US medical centers involving 381 women with refractory urgency urinary incontinence.Interventions: Cystoscopic intradetrusor injection of 200 U of onabotulinumtoxinA (n = 192) or sacral neuromodulation (n = 189).Main Outcomes and Measures: Primary outcome, change from baseline mean number of daily urgency urinary incontinence episodes over 6 months, was measured with monthly 3-day diaries. Secondary outcomes included change from baseline in urinary symptom scores in the Overactive Bladder Questionnaire Short Form (SF); range, 0-100, higher scores indicating worse symptoms; Overactive Bladder Satisfaction questionnaire; range, 0-100; includes 5 subscales, higher scores indicating better satisfaction; and adverse events.Results: Of the 364 women (mean [SD] age, 63.0 [11.6] years) in the intention-to-treat population, 190 women in the onabotulinumtoxinA group had a greater reduction in 6-month mean number of episodes of urgency incontinence per day than did the 174 in the sacral neuromodulation group (-3.9 vs -3.3 episodes per day; mean difference, 0.63; 95% CI, 0.13 to 1.14; P = .01). Participants treated with onabotulinumtoxinA showed greater improvement in the Overactive Bladder Questionnaire SF for symptom bother (-46.7 vs -38.6; mean difference, 8.1; 95% CI, 3.0 to 13.3; P = .002); treatment satisfaction (67.7 vs 59.8; mean difference, 7.8; 95% CI, 1.6 to 14.1; P = .01) and treatment endorsement (78.1 vs 67.6; mean difference; 10.4, 95% CI, 4.3 to 16.5; P < .001) than treatment with sacral neuromodulation. There were no differences in convenience (67.6 vs 70.2; mean difference, -2.5; 95% CI, -8.1 to 3.0; P = .36), adverse effects (88.4 vs 85.1; mean difference, 3.3; 95% CI, -1.9 to 8.5; P = .22), and treatment preference (92.% vs 89%; risk difference, -3%; 95% CI, -16% to 10%; P = .49). Urinary tract infections were more frequent in the onabotulinumtoxinA group (35% vs 11%; risk difference, -23%; 95% CI, -33% to -13%; P < .001). The need for self-catheterization was 8% and 2% at 1 and 6 months in the onabotulinumtoxinA group. Neuromodulation device revisions and removals occurred in 3%.Conclusions and Relevance: Among women with refractory urgency urinary incontinence, treatment with onabotulinumtoxinA compared with sacral neuromodulation resulted in a small daily improvement in episodes that although statistically significant is of uncertain clinical importance. In addition, it resulted in a higher risk of urinary tract infections and need for transient self-catheterizations. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To evaluate the effectiveness and safety of a vaginal bowel-control device and pump system for fecal incontinence treatment. METHODS: Women with a minimum of four fecal incontinence episodes over 2 weeks were fit with the intravaginal device. Treatment success, defined as a 50% or greater reduction of incontinent episodes, was assessed at 1 month. Participants were invited into an optional extended-wear period of another 2 months. Secondary outcomes included symptom improvement measured by the Fecal Incontinence Quality of Life, Modified Manchester Health Questionnaire, and Patient Global Impression of Improvement. Adverse events were collected. Intention-to-treat analysis included participants who were successfully fit entering treatment. Per protocol, analysis included participants with a valid 1-month treatment diary. RESULTS: Sixty-one of 110 (55.5%) participants from six clinical sites were successfully fit and entered treatment. At 1 month, intention-to-treat success was 78.7% (48/61, P<.001); per protocol success, 85.7% (48/56, P<.001) and 85.7% (48/56) considered bowel symptoms "very much better" or "much better." There was significant improvement in all Fecal Incontinence Quality of Life (P<.001) and Modified Manchester (P≤.007) subscales. Success rate at 3 months was 86.4% (38/44; 95% confidence interval 73-95%). There were no serious adverse events; the most common study-wide device-related adverse event was pelvic cramping or discomfort (25/110 participants [22.7%]), the majority of events (16/25 [64%]) occurring during the fitting period. CONCLUSION: In women successfully fit with a vaginal bowel-control device for nonsurgical treatment for fecal incontinence, there was significant improvement in fecal incontinence by objective and subjective measures. [ABSTRACT FROM AUTHOR]

Worldwide, the heterosexual route is the prevalent mode of HIV-1 transmission, and the female reproductive tract accounts for approximately 40% of all HIV-1 transmissions. HIV-1 infection in the female reproductive tract involves three major events: entry through the mucosal epithelium, productive infection in subepithelial mononuclear cells, and delivery to lymph nodes to initiate systemic infection. Here, we provide a focused review of the interaction between HIV-1 and mucosal epithelial cells, lymphocytes, macrophages, and dendritic cells in female genital mucosa. Increased understanding of these interactions could illuminate new approaches for interdicting HIV-1 heterosexual transmission. [ABSTRACT FROM AUTHOR]

We present the rationale for and design of a randomized, open-label, active-control trial comparing the effectiveness of 200units of onabotulinum toxin A (Botox A®) versus sacral neuromodulation (InterStim®) therapy for refractory urgency urinary incontinence (UUI). The Refractory Overactive Bladder: Sacral NEuromodulation vs. BoTulinum Toxin Assessment (ROSETTA) trial compares changes in urgency urinary incontinence episodes over 6months, as well as other lower urinary tract symptoms, adverse events and cost effectiveness in women receiving these two therapies. Eligible participants had previously attempted treatment with at least 2 medications and behavioral therapy. We discuss the importance of evaluating two very different interventions, the challenges related to recruitment, ethical considerations for two treatments with significantly different costs, follow-up assessments and cost effectiveness. The ROSETTA trial will provide information to healthcare providers regarding the technical attributes of these interventions as well as the efficacy and safety of these two interventions on other lower urinary tract and pelvic floor symptoms. Enrollment began in March, 2012 with anticipated end to recruitment in mid 2014. [ABSTRACT FROM AUTHOR]

Abstract: Women are seeking care for pelvic organ prolapse in increasing numbers and a significant proportion of them will undergo a second repair for recurrence. This has initiated interest by both surgeons and industry to utilize and design prosthetic mesh materials to help augment longevity of prolapse repairs. Unfortunately, the introduction of transvaginal synthetic mesh kits for use in women was done without the benefit of level 1 data to determine its utility compared with native tissue repair. This report summarizes the potential benefit/risks of transvaginal synthetic mesh use for pelvic organ prolapse and recommendations regarding its continued use. [ABSTRACT FROM AUTHOR]

Synthetic transvaginal mesh has been employed in the treatment of pelvic organ prolapse for more than a decade. As the use of these devices increased during this period so did adverse event reporting. In 2008, the Food and Drug Administration (FDA) Public Health Notification informed physicians and patients of rising concerns with the use of synthetic transvaginal mesh. Shortly thereafter and in parallel to marked increases in adverse event reporting within the Manufacturer and User Device Experience (MAUDE), the FDA released a Safety Communication regarding urogynecologic surgical mesh use. Following this report and in the wake of increased medical industry product withdrawal, growing medicolegal concerns, patient safety, and clinical practice controversy, many gynecologists and pelvic reconstructive surgeons are left with limited long-term data, clinical guidance, and growing uncertainty regarding the role of synthetic transvaginal mesh use in pelvic organ prolapse. This paper reviews the reported complications of synthetic transvaginal mesh with an evidence-based approach as well as providing suggested guidance for the future role of its use amidst the controversy. [ABSTRACT FROM AUTHOR]

The article focuses on a study which investigated demographic and clinical predictors of midurethral sling failure in women with stress urinary incontinence (SUI). The study found that overall odds of midurethral sling failure are more common with women with previous incontinence surgery, more severe urinary incontinence symptoms, and urethral hypomobility. Pad weight testing was also considered to be a powerful predictor of midurethal sling failure.

Shen R, Richter HE, Smith PD. Early HIV-1 target cells in human vaginal and ectocervical mucosa. Am J Reprod Immunol 2011; 65: 261-267 After translocation through the pleuristratified epithelium of the lower female genital tract, HIV-1 encounters potential target mononuclear cells in the lamina propria of the vagina and ectocervix. Here we show that each major type of genital mononuclear cells, including dendritic cells (DCs), macrophages and lymphocytes, are susceptible to HIV-1 in vitro. Among suspensions of vaginal and ectocervical mononuclear cells, DCs were the first cells to take up virus, containing GFP-tagged virions as early as 15 min after exposure. At 2 hr after exposure, DCs still contained the largest proportion of HIV-1 cells compared to lamina propria macrophages and lymphocytes from the same mucosal compartment. By 4 days, however, lymphocytes from both vaginal and ectocervical mucosa supported the highest level of HIV-1 replication. Genital macrophages from the same mucosal tissues also were permissive to HIV-1, in sharp contrast to intestinal macrophages, which we have shown previously do not support HIV-1 replication. Thus, among human vaginal and ectocervical mononuclear target cells, DCs are the first to take up HIV-1 and T cells support the most robust viral replication. Further characterization of the parameters of HIV-1 infection in genital mononuclear cells will enhance our understanding of HIV-1 infection in the female genital tract. [ABSTRACT FROM AUTHOR]

Background: Midurethral slings are increasingly used for the treatment of stress incontinence, but there are limited data comparing types of slings and associated complications. Methods: We performed a multicenter, randomized equivalence trial comparing outcomes with retropubic and transobturator midurethral slings in women with stress incontinence. The primary outcome was treatment success at 12 months according to both objective criteria (a negative stress test, a negative pad test, and no retreatment) and subjective criteria (self-reported absence of symptoms, no leakage episodes recorded, and no retreatment). The predetermined equivalence margin was ±12 percentage points. Results: A total of 597 women were randomly assigned to a study group; 565 (94.6%) completed the 12-month assessment. The rates of objectively assessed treatment success were 80.8% in the retropubic-sling group and 77.7% in the transobturator-sling group (3.0 percentage-point difference; 95% confidence interval [CI], −3.6 to 9.6). The rates of subjectively assessed success were 62.2% and 55.8%, respectively (6.4 percentage-point difference; 95% CI, −1.6 to 14.3). The rates of voiding dysfunction requiring surgery were 2.7% in those who received retropubic slings and 0% in those who received transobturator slings (P=0.004), and the respective rates of neurologic symptoms were 4.0% and 9.4% (P=0.01). There were no significant differences between groups in postoperative urge incontinence, satisfaction with the results of the procedure, or quality of life. Conclusions: The 12-month rates of objectively assessed success of treatment for stress incontinence with the retropubic and transobturator approaches met the prespecified criteria for equivalence; the rates of subjectively assessed success were similar between groups but did not meet the criteria for equivalence. Differences in the complications associated with the two procedures should be discussed with patients who are considering surgical treatment for incontinence. (ClinicalTrials.gov number, NCT00325039.) N Engl J Med 2010;362:2066-76. [ABSTRACT FROM AUTHOR]

The article presents a study which investigates the effectivity of the continence pessary, behavioral therapy, and combined therapy in treating stress urinary incontinence. It mentions that the randomized clinical and mulitisite trial or the Ambulatory Treatments for Leakage Associated with Stress Incontinence (ATLAS) were conducted among 446 women with urinary stress incontinence. It reveals that the behavioral therapy produced greater patient satisfaction in three months than pessary.

An interview with Professor Holly E. Richter is presented. She says that the prevalence of urinary incontinence (UI) in women range from 25% to 45%. Richer states that vaginal delivery is the predominant risk factor of UI in women. She stresses the need for close attention when recommending pelvic muscle training or Kegel exercises to women with UI.

Mucosal surfaces play a major role in human immunodeficiency virus type 1 (HIV-1) transmission and pathogenesis, and yet the role of lamina propria macrophages in mucosal HIV-1 infection has received little investigative attention. We report here that vaginal and intestinal macrophages display distinct phenotype and HIV-1 permissiveness profiles. Vaginal macrophages expressed the innate response receptors CD14, CD89, CD16, CD32, and CD64 and the HIV-1 receptor/coreceptors CD4, CCR5, and CXCR4, similar to monocytes. Consistent with this phenotype, green fluorescent protein-tagged R5 HIV-1 entered macrophages in explanted vaginal mucosa as early as 30 min after inoculation of virus onto the epithelium, and purified vaginal macrophages supported substantial levels of HIV-1 replication by a panel of highly macrophage-tropic R5 viruses. In sharp contrast, intestinal macrophages expressed no detectable, or very low levels of, innate response receptors and HIV-1 receptor/coreceptors and did not support HIV-1 replication, although virus occasionally entered macrophages in intestinal tissue explants. Thus, vaginal, but not intestinal, macrophages are monocyte-like and permissive to R5 HIV-1 after the virus has translocated across the epithelium. These findings suggest that genital and gut macrophages have different roles in mucosal HIV-1 pathogenesis and that vaginal macrophages play a previously underappreciated but potentially important role in mucosal HIV-1 infection in the female genital tract. [ABSTRACT FROM AUTHOR]

The article presents a study which investigated whether perioperative and postoperative outcomes after Burch colposuspension or pubovaginal sling for stress urinary incontinence (SUI) differed with age in the U.S. The study is a prospective secondary analysis of the Stress Incontinence Surgical Treatment Efficacy Trial. It is indicated that older women undergoing surgery for stress incontinence can expect to do and younger women with respect to perioperative outcomes.

The article presents a research from the U.S. Centers for Disease Control and Prevention (CDCP) and the World Health Organization (WHO) that summarizes the effect of obesity and outcomes of surgical treatment of pelvic floor disorders. It states that surgery for urinary incontinence (UI) in obese women is safe, but needs more trials in evaluating its long-term effectiveness. It is stated that weight loss should be considered in the treatment of pelvic floor disorders in the obese woman.

Abstract: Objectives: To determine the impact of urinary incontinence (UI) on quality of life in morbidly obese women seeking bariatric surgery compared with women seeking urogynecologic care. Methods: Women undergoing consultation for weight loss surgery completed questionnaires assessing the presence and severity of UI using the Medical, Epidemiological, and Social Aspects of Aging questionnaire and the impact of their UI using the Incontinence Impact Questionnaire-7 and Urogenital Distress Inventory-6. The charts of the women with UI seen in a urogynecology center were reviewed. For these two samples, pairs were matched for UI severity using the total Medical, Epidemiological, and Social Aspects of Aging scores, and the women within pairs were compared concerning the impact of UI. Results: A total of 93 pairs were matched. Morbidly obese women had lower scores on the Incontinence Impact Questionnaire-7 (mean 20.1 versus 42.0, P <0.0001) and the Urogenital Distress Inventory-6 (mean 30.4 versus 54.4, P <0.0001) compared with the urogynecology clinic patients. Conclusions: The results of our study have shown that the impact of UI is lower in morbidly obese women than in women seeking urogynecologic care. [Copyright &y& Elsevier]

The article examines the changes in the prevalence and severity of urinary incontinence (UI) and fecal incontinence in morbidly obese women undergoing laparoscopic weight loss surgery. It shows that the prevalence of UI and fecal incontinence decreased after bariatric surgery. The article also shows that the magnitude of weight loss is associated with the reduction in UI prevalence.

It examines surgical outcomes for benign disorders in older women in the United States. It describes the growing American geriatric population and the increasing demand for pelvic floor treatment and surgery. The article also discusses the common pelvic floor disorders that affect older women, and reviews surgical treatment options and outcomes.

OBJECTIVES: To compare perioperative morbidity and 1-year outcomes of older and younger women undergoing surgery for pelvic organ prolapse (POP). DESIGN: Prospective ancillary analysis. SETTING: Academic medical centers in National Institutes of Health, National Institute of Child Health and Human Development Colpopexy and Urinary Reduction Study. PARTICIPANTS: Women with POP and no symptoms of stress incontinence. INTERVENTION: Abdominal sacrocolpopexy with randomization to receive Burch colposuspension for treatment of possible occult incontinence or not. MEASUREMENTS: Perioperative complications and Pelvic Organ Prolapse Quantification and quality-of-life (QOL) questionnaires (Pelvic Floor Distress Inventory, Pelvic Floor Impact Questionnaire, and Medical Outcomes Study Short-Form Health Survey (SF-36) preoperatively, immediately postoperatively, and 6 weeks and 3 and 12 months postoperatively). RESULTS: Three hundred twenty-two women aged 31 to 82 (21% aged ≥70), 93% white. Older women had higher baseline comorbidity ( P<.001) and more severe POP ( P=.003). Controlling for prolapse stage and whether Burch was performed, there were no age differences in complication rates. Older women had longer hospital stays (3.1±1.0 vs 2.7±1.5 days, P=.02) and higher prevalence of incontinence at 6 weeks (54.7% vs 37.2%, P=.005). At 3 and 12 months, there were no differences in self-reported incontinence, stress testing for incontinence, or prolapse stage. Improvements from baseline were significant on all QOL measures but with no age differences. CONCLUSION: Outcomes of prolapse surgery were comparable between older and younger women except that older women had slightly longer hospital stays. [ABSTRACT FROM AUTHOR]

Background: Many surgical procedures are available for women with urinary stress incontinence, yet few randomized clinical trials have been conducted to provide a basis for treatment recommendations. Methods: We performed a multicenter, randomized clinical trial comparing two procedures - the pubovaginal sling, using autologous rectus fascia, and the Burch colposuspension - among women with stress incontinence. Women were eligible for the study if they had predominant symptoms associated with the condition, a positive stress test, and urethral hypermobility. The primary outcomes were success in terms of overall urinary-incontinence measures, which required a negative pad test, no urinary incontinence (as recorded in a 3-day diary), a negative cough and Valsalva stress test, no self-reported symptoms, and no retreatment for the condition, and success in terms of measures of stress incontinence specifically, which required only the latter three criteria. We also assessed postoperative urge incontinence, voiding dysfunction, and adverse events. Results: A total of 655 women were randomly assigned to study groups: 326 to undergo the sling procedure and 329 to undergo the Burch procedure; 520 women (79%) completed the outcome assessment. At 24 months, success rates were higher for women who underwent the sling procedure than for those who underwent the Burch procedure, for both the overall category of success (47% vs. 38%, P=0.01) and the category specific to stress incontinence (66% vs. 49%, P<0.001). However, more women who underwent the sling procedure had urinary tract infections, difficulty voiding, and postoperative urge incontinence. Conclusions: 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.) N Engl J Med 2007;356:2143-55. [ABSTRACT FROM AUTHOR]

The article discusses a study designed to estimate whether findings from endoanal ultrasonography are more prevalent in primiparous women with a history of anal sphincter tear than in women without this history, and whether the findings are associated with fecal incontinence symptoms. The study involved 251 primiparous women who underwent standardized ultrasound assessment of the internal and external anal sphincter six to 12 months after delivery.

The article investigates maternal, newborn, and obstetrics risk factors related to anal sphincter tear in multiparous women. The study pinpointed 18,779 multiparous vaginal deliveries from 1992-2004 from an obstetric automated record database at the University of Alabama at Birmingham. The strongest clinical risk factors for anal sphincter tear in multiparous women are episiotomy, shoulder dystocia, previous sphincter tear, prolonged second stage labor, and forceps delivery.

OBJECTIVE: To estimate prevalence and correlates of urinary and anal incontinence in morbidly obese women undergoing evaluation for laparoscopic weight loss surgery. METHODS: From October 2003 to February 2005, 180 women with body mass index (BMI) of 40 or greater underwent evaluation for laparoscopic weight loss surgery. Using an established Web site, questionnaires were completed to assess symptoms of urinary incontinence, including the Medical, Epidemiological, and Social Aspects of Aging Questionnaire (MESA). Anal incontinence was assessed by asking, ‘Do you have any uncontrolled anal leakage?’ A number of clinical and demographic variables were examined as potential risk factors for urinary incontinence and anal incontinence. RESULTS: Mean age was 39.8 years (range 16–55). Body mass index ranged from 40 to 81 (mean 49.5). Prevalence of urinary incontinence was 66.9% and anal incontinence was 32.0% (45.6% loss of gas only, 21.1% liquid stool only, 24.6% gas and liquid stool only, 8.8% solid stool). In simple logistic regression, presence of urinary incontinence was associated with age (odds ratio [OR] 1.05, 95% confidence interval [CI] 1.01–1.09), number of children (OR 1.54, 95% CI 1.15–2.07), anal incontinence (OR 6.34, 95% CI 2.52–15.93), arthritis (OR 6.04, 95% CI 1.76–20.78), and sleep apnea (OR 2.30, 95% CI 1.21–4.37). Multivariable logistic regression identified 3 factors independently associated with urinary incontinence: number of children (OR 1.55, 95% CI 1.12–2.12), arthritis (OR 5.46, 95% CI 1.51–19.73), and anal incontinence (OR 6.27, 95% CI 2.42–16.26). Presence of anal incontinence was associated only with the presence of urinary incontinence (OR 6.34, 95% CI 2.52–15.93). CONCLUSION: Prevalence of urinary and anal incontinence is high in this group of morbidly obese women as compared with the general population. Studies are needed to determine the effect of weight loss on urinary and anal incontinence symptoms in the morbidly obese woman. [ABSTRACT FROM AUTHOR]

Pelvic organ prolapse, including anterior and posterior vaginal prolapse, uterine prolapse, and enterocele, is a common group of clinical conditions affecting millions of American women. This article, designed for the practicing clinician, highlights the clinical importance of prolapse, its pathophysiology, and approaches to diagnosis and therapy. Prolapse encompasses a range of disorders, from asymptomatic altered vaginal anatomy to complete vaginal eversion associated with severe urinary, defecatory, and sexual dysfunction. The pathophysiology of prolapse is multifactorial and may operate under a "multiple-hit" process in which genetically susceptible women are exposed to life events that ultimately result in the development of clinically important prolapse. The evaluation of women with prolapse requires a comprehensive approach, with attention to function in all pelvic compartments based on a detailed patient history, physical examination, and limited testing. Although prolapse is associated with many symptoms, few are specific for prolapse; it is often challenging for the clinician to determine which symptoms are attributable to the prolapse itself and will therefore improve or resolve once the prolapse is treated. When treatment is warranted based on specific symptoms, prolapse management choices fall into 2 broad categories: nonsurgical, which includes pelvic floor muscle training and pessary use; and surgical, which can be reconstructive (eg, sacral colpopexy) or obliterative (eg, colpocleisis). Concomitant symptoms require additional management. Virtually all women with prolapse can be treated and their symptoms improved, even if not completely resolved. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To examine whether knowledge of deficits obtained in a preoperative geriatric assessment may benefit postoperative health outcomes in older women undergoing pelvic surgery. METHODS: This study employed a pre-post intervention cohort design. Primary outcome was difference in scores of the Physical Component Summary and Mental Component Summary of the Medical Outcomes Study Short Form 36 Health Survey in 62 older women who had undergone ‘usual’ compared with an ‘enhanced’ preoperative assessment consisting of Activities of Daily Living, Instrumental Activities of Daily Living, Get Up and Go Test, Draw a Clock Test, Mini Nutritional Assessment, Geriatric Depression Scale, and Social Support Scale. The assessment results were placed on the participant's hospital chart. Repeated measures analysis was used. RESULTS: There were no significant differences in Mental Component Summary scores between the usual and enhanced assessment cohorts preoperatively (mean ± standard deviation; 49.14 ± 10.61 compared with 53.2 ± 9.33), at 6 weeks (53.69 ± 8.61 compared with 55.47 ± 9.46), or at 6 months postoperatively (53.85 ± 10.77 compared with 56.25 ± 7.25); P = .120 for group effect and P = .798 for group by time interaction. Significant time effect was noted (P = .036). There was no significant difference in Physical Component Summary scores between the usual and enhanced assessment cohorts with respect to group effect (P = .986); there was a significant time effect (P = « .001) and a significant group by time interaction (P = .026). Satisfaction with treatment was high in both cohorts at 6 weeks and 6 months. CONCLUSION: A preoperative geriatric assessment did not seem to have differential benefit in healthy older women undergoing elective pelvic floor surgery. [ABSTRACT FROM AUTHOR]

The composition and structure of native riverine ecosystems are tightly linked to natural hydrologic variability. By managing river flows for water supplies and power generation, water management agencies have inadvertently caused considerable degradation of riverine ecosystems and associated biodiversity. New approaches for meeting human needs for water while conserving the ecological integrity of riverine ecosystems are greatly needed. We describe an approach for identifying the natural flooding characteristics that must be protected or restored to maintain riparian ( floodplain) ecosystems along meandering rivers. We developed a computer model to simulate flood-driven changes in the relative abundance of riparian patch types along the Yampa River in Colorado ( U.S.A.). The model is based on research suggesting that the duration of flooding at or above 209 m3 per second (125% of bankfull discharge) is particularly important in driving lateral channel migration, which is responsible for initiating ecological succession in the Yampa's riparian forest. Other hydrologic variables, such as the magnitude of annual peak flows, were not as strongly correlated with lateral channel migration rates. Model simulations enabled us to tentatively identify a threshold of alteration of flood duration that could lead to substantial changes in the abundance of forest patch types over time should river flows be regulated by future water projects. Based on this analysis, we suggest an ecologically compatible water management approach that avoids crossing flood alteration thresholds and provides opportunity to use a portion of flood waters for human purposes. Recommended improvements to the Yampa model include obtaining additional low-elevation aerial photographs of the river corridor to enable better estimation of channel migration rates and vegetation changes. These additional data should greatly improve the model's accuracy and predictive capabilities and therefore... [ABSTRACT FROM AUTHOR]

Objective: To determine intrapartum factors associated with perineal laceration at delivery. Methods: This was a planned secondary analysis of a multicenter randomized clinical trial of delayed versus immediate pushing among term nulliparous women in labor with neuraxial analgesia conducted in the United States. Intrapartum characteristics were extracted from the medical charts. The primary outcome was perineal laceration, defined as second degree or above, characterized at delivery in women participating in longer term pelvic floor assessments post-delivery. Multivariable logistic regression was used to refine risk estimates while adjusting for randomization group, birth weight, and maternal age. Results: Among the 941 women participating in the pelvic floor follow-up, 40.6% experienced a perineal laceration. No first stage labor characteristics were associated with perineal laceration, including type of labor or length of first stage. Receiving an amnioinfusion appeared protective of perineal laceration (adjusted odds ratio, 0.48; 95% confidence interval 0.26–0.91; P = 0.01). Second stage labor characteristics associated with injury were length of stage (2.01 h vs. 1.50 h; adjusted odds ratio, 1.36; 95% confidence interval 1.18–1.57; P < 0.01) and a prolonged second stage (adjusted odds ratio, 1.64; 95% confidence interval 1.06–2.56; P < 0.01). Operative vaginal delivery was strongly associated with perineal laceration (adjusted odds ratio, 3.57; 95% confidence interval 1.85–6.90; P < 0.01). Conclusion: Operative vaginal delivery is a modifiable risk factor associated with an increased risk of perineal laceration. Amnioinfusion appeared protective against injury, which could reflect a spurious finding, but may also represent true risk reduction similar to the mechanism of warm perineal compress. Significance: The objective of this study was to examine intrapartum factors associated with an increased risk of perineal laceration at delivery among nulliparous women. Operative vaginal delivery and the length of second stage, particularly prolonged second stage, are modifiable risk factors associated with an increased risk of perineal laceration. Receiving an amnioinfusion appeared to be protective against perineal laceration. There are few intrapartum modifiable risk factors other than operative delivery for perineal laceration in nulliparous women. Length of the second stage is an important risk factor for perineal lacerations that is modifiable through active management. [ABSTRACT FROM AUTHOR]

Presents a case study of a woman who had a subacute uterine inversion on postpartum day ten. Medical background of the patient; Surgical procedure performed to reposition the inverted uterus; Discussion on postpartum uterine inversion.

Background and Objectives: Vaginal acidification has been suggested as a means of normalizing the vaginal flora. Goal: The purpose of this study was to determine the effectiveness of an acetic acid-based vaginal gel in the treatment of bacterial vaginosis (BV). Study Design: Forty-four patients with BV were enrolled in a randomized, double-blind clinic trial. Of these, 29 were evaluable. Patients were randomized to receive either 5 mL acetic acid gel (n = 14) or placebo gel (n = 15) intravaginally twice daily for 7 days. Clinical criteria and vaginal Gram stain scores were compared between the initial visit and at 2 weeks after initiating therapy. Results: No significant differences were noted when comparing drug and placebo in terms of subjective or clinical improvement or improvement in Gram stain smears for bacterial vaginosis. Conclusion: Vaginal acidification with an acetic acid gel formulated to pH 3.9 to 4.1 was ineffective therapy for bacterial vaginosis. [ABSTRACT FROM AUTHOR]

Introduction and hypothesis: There are sparse data regarding the long-term efficacy of pelvic floor muscle training (PFMT) for the treatment of urinary incontinence (UI). The objective of this study was to evaluate the impact of an 8-week PFMT program guided by a motion-based intravaginal device versus a standard home program over 24 months. Methods: Between October 2020 and March 2021, a total of 363 women with stress or stress-predominant mixed UI were randomized and completed an 8-week PFMT program using a motion-based intravaginal device (intervention group) or a home program following written/video instructions (control group). Participants were not asked to continue training after the 8-week program. At 18 and 24 months' follow-up, the Urogenital Distress Inventory, short-form (UDI-6) and Patient Global Impression of Improvement (PGI-I) were collected. In the original trial, a total of 139 participants in each arm were needed to detect a 0.3 effect size (alpha = 0.05, power 0.8, one-tailed t test) in the difference in UDI-6 scores. Results: A total of 231 participants returned 24-month data. Mean age at 24 months was 51.7 ± 14.5 years, and mean BMI was 31.8 ± 7.4 kg/m2. Mean change in UDI-6 scores from baseline to 24 months was greater in the intervention group than the control group (−21.1 ± 24.5 vs −14.8 ± 19.4, p = 0.04). Reported improvement using PGI-I was greater in the intervention group than in the control group at 24 months (35% vs 22%, p = 0.03, OR 1.95(95% CI 1.08, 3.57). Conclusions: Pelvic floor muscle training guided by a motion-based prescription intravaginal device yielded durable and significantly greater UI symptom improvement than a standard home program, even in the absence of continued therapy. [ABSTRACT FROM AUTHOR]

Neurologic disease as a cause of chronic pelvic pain may be more common than previously reported. We report three cases wherein patients with complaints of pelvic pain were subsequently found to have neurologic disease involving the lumbosacral spine. In all three cases, the presenting features were complaints of cyclic or noncyclic lower abdominal pain attributed to endometriosis, pelvic inflammatory disease, or uterine fibroids. When conventional therapies failed to resolve the pain, magnetic resonance imaging (MRI) of the lumbosacral spine showed a neoplasm in one patient and disk herniation in two patients. Evolving lumbar disk disease or intradural neoplasms in the upper lumbar area can produce symptoms interpreted as pelvic pain. Symptoms consistent with radiculopathy occurred late in the course of each of the three cases reported. [ABSTRACT FROM AUTHOR]

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.Trial Registration: ClinicalTrials.gov Identifier: NCT01802281. [ABSTRACT FROM AUTHOR]

Introduction and hypothesis: In women with advanced prolapse, differences in vaginal apex anchoring sites may impact surgical outcomes over time. The primary aim was to compare 5-year surgical outcomes of uterosacral ligament suspension (ULS) versus sacrospinous ligament fixation (SSLF) in women with advanced (stage III–IV) prolapse. Methods: A secondary analysis was conducted in a subset of women with advanced prolapse from a multicenter randomized trial comparing ULS versus SSLF and its extended follow-up, using publicly accessible de-identified datasets. The primary outcome was time to failure, defined as any one of (1) apical descent > 1/3 into the vaginal canal or anterior/posterior compartment beyond the hymen, (2) bothersome vaginal bulge symptoms, or (3) re-treatment. Secondary outcomes include symptom severity measured by the Pelvic Organ Prolapse Distress Inventory (POPDI) and adverse events. Results: Of 285 women, 90/147 (61.2%) in ULS and 88/138 (63.8%) in SSLF had advanced prolapse. Baseline characteristics did not differ between groups except for median-vaginal deliveries (3.0 [2.0, 5.0] versus 3.0 [2.0, 4.0], p < 0.01). The median time to failure was 1.7 years ULS versus 2.0 years SSLF (p = 0.42). Surgical failure increased over time in both groups with no intergroup difference; by year 5, the estimated failure rate was 67.7% ULS versus 71.5% SSLF (adjusted difference −3.8; 95%CI [−21.9, 14.2]). No differences were noted in individual failure components (p > 0.05). POPDI scores improved over 5 years without intergroup difference (ULS −68.0 ± 61.1 versus SSLF −69.9 ± 60.3, adjusted difference −0.1 [−20.0, 19.9]). No difference in adverse events were observed (p > 0.05). Conclusion: In women with advanced prolapse, surgical failure, symptom severity, and adverse events did not differ between ULS and SSLF over 5 years. [ABSTRACT FROM AUTHOR]

Introduction and hypothesis: In randomized trials both percutaneous tibial nerve stimulation (PTNS) and sham result in clinically significant improvements in accidental bowel leakage (ABL). We aimed to identify subgroups who may preferentially benefit from PTNS in women enrolled in a multicenter randomized trial. Methods: This planned secondary analysis explored factors associated with success for PTNS vs sham using various definitions: treatment responder using three cutoff points for St. Mark's score (≥3-, ≥4-, and ≥5-point reduction); Patient Global Impression of Improvement (PGI-I) of ≥ much better; and ≥50% reduction in fecal incontinence episodes (FIEs). Backward logistic regression models were generated using elements with significance of p<0.2 for each definition and interaction terms assessed differential effects of PTNS vs sham. Results: Of 166 women randomized, 160 provided data for at least one success definition. Overall, success rates were 65% (102 out of 158), 57% (90 out of 158), and 46% (73 out of 158) for ≥3-, ≥4-, and ≥5-point St Mark's reduction respectively; 43% (68 out of 157) for PGI-I; and 48% (70 out of 145) for ≥50% FIEs. Of those providing data for all definitions of success, 77% (109 out of 142) met one success criterion, 43% (61 out of 142) two, and 29% (41 out of 142) all three success criteria. No reliable or consistent factors were associated with improved outcomes with PTNS over sham regardless of definition. Conclusions: Despite exploring diverse success outcomes, no subgroups of women with ABL differentially responded to PTNS over sham. Success results varied widely across subjective and objective definitions. Further investigation of ABL treatment success definitions that consistently and accurately capture patient symptom burden and improvement are needed. [ABSTRACT FROM AUTHOR]

Concomitant surgery did not result in improved quality of life compared with cancer surgery alone for patients with endometrial intraepithelial neoplasia and those with early-stage endometrial cancer with stress urinary incontinence. OBJECTIVE: To compare quality of life (QOL) among patients with endometrial intraepithelial neoplasia or early-stage endometrial cancer and stress urinary incontinence (SUI) who chose to have concomitant surgery with cancer surgery alone. METHODS: A multicenter, prospective cohort study was conducted across eight U.S. sites. Potentially eligible patients were screened for SUI symptoms. Those who screened positive were offered referral to urogynecology and incontinence treatment, including concomitant surgery. Participants were categorized into two groups: 1) concomitant cancer and SUI surgery or 2) cancer surgery alone. The primary outcome was cancer-related QOL as measured by the FACT-En (Functional Assessment of Cancer Therapy–Endometrial) (range 0–100; higher score indicates better QOL). The FACT-En and questionnaires assessing urinary symptom–specific severity and effects were assessed before surgery and 6 weeks, 6 months, and 12 months after surgery. Adjusted median regression accounting for clustering was used to examine the relationship between SUI treatment group and FACT-En scores. RESULTS: Of 1,322 (53.1%) patients, 702 screened positive for SUI with 532 analyzed; 110 (21%) chose concomitant cancer and SUI surgery, and 422 (79%) chose cancer surgery alone. FACT-En scores increased for both the concomitant SUI surgery and cancer surgery–only groups from the preoperative to the postoperative period. After adjustment for timepoint and preoperative covariates, the median change in FACT-En score (postoperative−preoperative) was 1.2 points higher (95% CI −1.3 to 3.6) for the concomitant SUI surgery group compared with the cancer surgery–only group across the postoperative period. Median time until surgery (22 days vs 16 days; P <.001), estimated blood loss (150 mL vs 72.5 mL; P <.001), and operative time (185.5 minutes vs 152 minutes; P <.001) were all greater for the concomitant cancer and SUI surgery group compared with the cancer-only group, respectively. CONCLUSION: Concomitant surgery did not result in improved QOL compared with cancer surgery alone for endometrial intraepithelial neoplasia and patients with early-stage endometrial cancer with SUI. However, FACT-En scores were improved in both groups. [ABSTRACT FROM AUTHOR]

Among nulliparous patients who receive neuraxial analgesia, the timing of second-stage pushing did not affect the risk of pelvic floor morbidity through 6 months postpartum. OBJECTIVE: To assess whether immediate or delayed pushing in the second-stage results in higher risk of pelvic floor morbidity. METHODS: This study was a planned secondary aim of a multicenter randomized clinical trial that included nulliparous patients at 37 weeks of gestation or greater in labor with neuraxial analgesia. Participants were randomized in the second stage to initiate pushing immediately or wait 60 minutes before pushing. Participants had pelvic floor assessments at 1–5 days postpartum, 6 weeks postpartum, and 6 months postpartum. Rates of perineal lacerations, pelvic organ prolapse quantification (POP-Q) measures, and scores on validated symptom-specific distress and quality-of-life questionnaires (PFDI-20 [Pelvic Floor Distress Inventory], PFIQ [Pelvic Floor Impact Questionnaire], FISI [Fecal Incontinence Severity Index], and MMHQ [Modified Manchester Health Questionnaire]) were compared. It was estimated that 630 participants would provide more than 80% power to detect a 40% difference in second-degree or greater perineal lacerations and approximately 80% power to detect a 40% difference in stage 2 or greater pelvic organ prolapse (POP). RESULTS: Among 2,414 participants in the primary trial conducted between May 19, 2014, and December 16, 2017, 941 (39%) had pelvic floor assessments: 452 immediate pushing and 489 delayed pushing. The mean age was 24.8 years, and 93.4% had vaginal delivery. There were no significant differences in perineal lacerations at delivery and POP at 6 weeks and 6 months postpartum. Changes from baseline in total and subscale scores for the PFDI-20, the PFIQ, and the MMHQ were not significantly different at 6 weeks postpartum and 6 months postpartum. The change in FISI score was higher in the immediate pushing group at 6 months (2.9±5.7 vs 2.0±4.5, difference 0.9, P =.01), but less than the minimum important difference of 4. CONCLUSION: Among nulliparous patients in the second stage with neuraxial analgesia, immediate pushing, compared with delayed pushing, did not increase perineal lacerations, POP-Q measures, or patient-reported pelvic floor symptoms at 6 weeks and 6 months postpartum. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02137200. [ABSTRACT FROM AUTHOR]

Treatment of anterior vaginal prolapse (AVP), suffered by over 500,000 women in the USA, is a challenge in urogynecology because of the poorly understood mechanics of AVP. Recently, computational modeling combined with finite element method has been used to model AVP through the study of pelvic floor muscle and connective tissue impairments on the anterior vaginal wall (AVW). Also, the effects of pelvic organ displacements on the AVW were studied numerically. In our current work, an MRI-based full-scale biofidelic computational model of the female pelvic system composed of the urinary bladder, vaginal canal, and the uterus was developed, and a novel finite element method framework was employed to simulate vaginal tissue stiffening and also bladder filling due to expansion for the first time. A mesh convergence study was conducted to choose a computationally efficient mesh, and a non-linear hyperelastic Yeoh's material model was adopted for the study. The AVW displacements, mechanical stresses, and strains were estimated at varying degrees of bladder fills and vaginal tissue stiffening. Both bladder filling and vaginal stiffening were found to increase the stress concentration on the AVW with varying trends, which have been discussed in detail in the paper. To our knowledge, this study is the first to estimate the individual and combined effects of bladder filling and vaginal tissue stiffening due to prolapse on the AVW. Copyright © 2016 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

Pelvic floor muscle training for the treatment of urinary incontinence using a digital therapeutic device shows long-term superior efficacy compared with home pelvic floor muscle training. OBJECTIVE: To evaluate the long-term efficacy of an 8-week regimen of pelvic floor muscle training guided by a motion-based digital therapeutic device compared with a standard home program in the treatment of stress urinary incontinence (SUI) and stress-predominant mixed urinary incontinence (MUI). METHODS: The primary virtual trial was conducted from October 2020 to March 2021; 363 women with SUI or stress-predominant MUI were randomized to complete pelvic floor muscle training using the device (intervention group) or a standard home pelvic floor muscle training program (control group) for 8 weeks. Primary outcomes included change in UDI-6 (Urogenital Distress Inventory, Short Form) score and SUI episodes on a 3-day bladder diary. The PGI-I (Patient Global Impression of Improvement) was also assessed, with "much better" and "very much better" responses considered as improvement. In this planned secondary analysis, symptom and adherence data were collected in follow-up at 6 and 12 months. A modified intention-to-treat analysis was performed using Student's t tests and χ2 tests as appropriate. RESULTS: Of 299 participants analyzed at 8 weeks, 286 (95.7%) returned 6- and 12-month data (151 in the control group, 135 in the intervention group). Mean age was 51.9±12.8 years, and mean body mass index (BMI) was 31.8±7.4; 84.6% of participants were parous, and 54.9% were postmenopausal. Mean change in UDI-6 score from baseline to 6 and 12 months was significantly greater in the intervention group than in the control group (20.2±20.9 vs 14.8±19.5, P =.03 and 22.7±23.3 vs 15.9±20.3, P =.01, respectively). Participants in the intervention group had more than twice the odds of reporting improvement on the PGI-I compared with participants in the control group (OR 2.45, 95% CI 1.49–4.00). CONCLUSION: Pelvic floor muscle training guided by a motion-based digital therapeutic device yielded significantly greater urinary incontinence symptom improvement compared with a standard home pelvic floor muscle training program at 6 and 12 months, although continued improvement waned over time. This technology may facilitate pelvic floor muscle training access and adherence for women with SUI and stress-predominant MUI and represents an effective modality for scaling first-line care. FUNDING SOURCE: Renovia Inc. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT04508153. [ABSTRACT FROM AUTHOR]