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Introduction and hypothesis: Postoperative cognitive dysfunction (POCD), a transient impairment of memory, concentration, and information processing, has been reported after 7–26% of non-cardiac surgeries with associated increase in morbidity and death. Our primary aim was to determine the incidence of POCD 2 weeks after prolapse surgery in women ≥ 60 years old. Our secondary aim was to identify risk factors for POCD. Methods: Prospective cohort study of women ≥ 60 years old scheduled for pelvic organ prolapse surgery. Exclusion criteria included cognitive impairment history, major neurologic disorder, and abnormal cognition screen. A comprehensive neuropsychologic (NP) battery (eight tests), administered 2 weeks pre- and post-surgery, assessed premorbid IQ and domains of attention, memory, and executive function. The primary outcome was defined as decline of ≥ 1 SD on ≥ 2 NP tests or decline of ≥ 2 SD on ≥ 1 test. Raw scores were transformed to Z-scores. Results: NP testing was completed by 72 women, median age 72 (IQR 69–77) years. Procedures included 16 (22.9%) laparoscopic sacrocolpopexies, 23 (32.9%) transvaginal reconstructions, and 29 (41.4%) obliterative surgeries, performed under general (63, 90%), regional (5, 7.1%), or sedation (2, 2.9%) anesthesia with a median hospital stay of 0.6 (IQR 0.6–0.75) days. POCD incidence was 33.3% (n = 24). POCD was associated with greater frailty (p = 0.006) and higher baseline depression (p = 0.05) but not with older age (p = 0.77) or inhalational gas use (p = 1.0). Conclusion: In this cohort, one in three women manifested POCD 2 weeks after prolapse surgery. Preoperative counseling should include discussions on POCD given its detrimental impact on postoperative recovery and independence. [ABSTRACT FROM AUTHOR]

Introduction and hypothesis: The objective was to determine if a bowel preparation prior to minimally invasive sacrocolpopexy (MIS) influences post-operative constipation symptoms. We hypothesized that women who underwent a bowel preparation would have an improvement in post-operative defecatory function. Methods: In this randomized controlled trial, women undergoing MIS received a pre-operative bowel preparation or no bowel preparation. Our primary outcome was post-operative constipation measured by the Patient Assessment of Constipation Symptoms (PAC-SYM) 2 weeks post-operatively. Secondary outcomes included surgeon's perception of case difficulty. Both intention-to-treat (ITT) and per-protocol analyses (PPA) were performed. Analyses were carried out using t test, Fisher's exact test, the Wilcoxon test and the Chi-squared test. Results: Of 105 enrolled women, 95 completed follow-up (43 preparation and 52 no preparation). Baseline characteristics and rates of complications were similar. No differences were noted on ITT. The post-operative abdominal PAC-SYM subscale was closer to baseline for women who received a bowel preparation on PPA (change in score 0.74 vs 1.08, p = 0.045). Women who underwent a preparation were less likely to report strain (6.0% vs 26.7%, p = 0.009) or type 1 Bristol stool on their first post-operative bowel movement (4.3% vs 17.5%, p = 0.047). Surgeons were more likely to rate the complexity of the case as "more difficult than average" (54.4% vs 40.1%, p = 0.027) in those without a bowel preparation. Conclusions: Although there was no difference in ITT analysis, women who underwent a bowel preparation prior to MIS demonstrated benefit to post-operative defecatory function with a corresponding improvement in surgeon's perception of case complexity. [ABSTRACT FROM AUTHOR]

Objective: To estimate whether nitrofurantoin prophylaxis decreases the incidence of culture-documented urinary tract infection for women with catheter-managed urinary retention after pelvic reconstructive surgery.Methods: This double-blind, placebo-controlled, randomized trial was conducted at five academic institutions. Women with urinary retention after surgery for prolapse or incontinence were randomized to oral nitrofurantoin 100 mg daily during indwelling or clean intermittent self-catheterization. The primary outcome was the incidence of symptomatic urinary tract infection within 6 weeks of surgery, confirmed by culture demonstrating more than 1,000 colony forming units per milliliter of uropathogenic bacteria. Secondary outcomes were adverse symptoms possibly attributable to nitrofurantoin and bacterial resistance to nitrofurantoin. A sample size of 154 would detect a decrease in urinary tract infection incidence from 33% to 13%, with 80% power, two-sided alpha of 0.05, and allow 10% dropout.Results: Of 154 participants randomized from September 2016 to May 2018, 151 were eligible for analysis: 75 received nitrofurantoin, and 76 received placebo. Demographics were similar between groups. The indication for surgery was prolapse (46%), incontinence (20%), or a combination (34%). Participants were discharged with an indwelling catheter (58%) or performing self-catheterization (42%). Median duration of catheter use was 4 days (interquartile range 3-7). Thirteen women in the nitrofurantoin group and 13 women in the placebo group experienced urinary tract infection (17.3% vs 17.1%, P=.97, relative risk [RR] [95% CI] 1.01 [0.50-2.04]). Adverse symptoms possibly attributable to nitrofurantoin were common in both groups (68% vs 61%, P=.34, RR [95% CI] 1.12 [0.88-1.43]). Resistance to nitrofurantoin was identified in seven urine cultures, four among nitrofurantoin and three among placebo recipients. In total, 52 urine cultures were obtained to evaluate symptoms of urinary tract infection, and only 27 of 52 grew at least 1,000 cfu/mL of uropathogenic bacteria.Conclusion: Daily nitrofurantoin did not reduce the incidence of culture-proven urinary tract infection among women with catheter-managed urinary retention after pelvic reconstructive surgery. Culture confirmed urinary tract infection in only half of symptomatic episodes.Clinical Trial Registration: ClinicalTrials.gov, NCT02727322. [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]

Introduction and hypothesis: We describe the rationale and methods of a study designed to compare vaginal and urinary microbiomes in women with mixed urinary incontinence (MUI) and similarly aged, asymptomatic controls. Methods: This paper delineates the methodology of a supplementary microbiome study nested in an ongoing randomized controlled trial comparing a standardized perioperative behavioral/pelvic floor exercise intervention plus midurethral sling versus midurethral sling alone for MUI. Women in the parent study had at least 'moderate bother' from urgency and stress urinary incontinence symptoms (SUI) on validated questionnaire and confirmed MUI on bladder diary. Controls had no incontinence symptoms. All participants underwent vaginal and urine collection for DNA analysis and conventional urine culture. Standardized protocols were designed, and a central lab received samples for subsequent polymerase chain reaction (PCR) amplification and sequencing of the bacterial16S ribosomal RNA (rRNA) gene. The composition of bacterial communities will be determined by dual amplicon sequencing of variable regions 1-3 and 4-6 from vaginal and urine specimens to compare the microbiome of patients with controls. Sample-size estimates determined that 126 MUI and 84 control participants were sufficient to detect a 20 % difference in predominant urinary genera, with 80 % power and 0.05 significance level. Results: Specimen collection commenced January 2015 and finished April 2016. DNA was extracted and stored for subsequent evaluation. Conclusions: Methods papers sharing information regarding development of genitourinary microbiome studies, particularly with control populations, are few. We describe the rigorous methodology developed for a novel urogenital microbiome study in women with MUI. [ABSTRACT FROM AUTHOR]

Objective: To determine whether concomitant surgeries affected outcomes in a randomized trial comparing retropubic midurethral sling (MUS) vs transobturator MUS. Methods: Subjects (n = 597) were stratified into 4 groups based on type of concomitant surgeries: group I had anterior/apical with or without posterior repairs (n = 79, 13%); group II had posterior repairs or perineorrhaphy only (n = 38, 6%); group III had nonprolapse procedures (n = 34, 6%); and group IV had no concomitant surgeries (n = 446, 75%). Complication rates, voiding dysfunction, objective and subjective surgical failure rates, and changes in urodynamic values (postop minus preop) were assessed and compared in these 4 groups. Results: There were no differences in complications, voiding dysfunction, and subjective failure outcomes between these 4 groups. Group I had lower odds ratio of objective surgical failure compared with group IV (OR 0.38, 95% CI 0.18-0.81, P = .05). The OR of failure of all patients undergoing concomitant surgeries (groups I-III) was lower than group IV (OR 0.57, 95% CI 0.35-0.95, P = .03). The change in Pdet@Qmax (from pressure-flow) was significantly higher in group III vs IV (P = .01). The change in Qmax. (from uroflowmetry) was significantly less in groups I and II vs group IV (P = .046 and .04, respectively). Conclusion: Concomitant surgeries did not increase complications. Subjects who underwent certain concomitant surgeries had lower failure rates than those undergoing slings only. These data support safety and efficacy of performing concomitant surgery at the time of MUS. [ABSTRACT FROM AUTHOR]

Background: Older participants are often excluded from clinical trials, precluding a representative sample.Study Design: Using qualitative and quantitative methods, we examined recruitment and retention of older women with pelvic organ prolapse in two surgical trials: the randomized Colpopexy And Urinary Reduction Efforts (CARE) study and the Longitudinal Pelvic Symptoms and Patient Satisfaction After Colpocleisis cohort study. Using focus groups, we developed a questionnaire addressing factors facilitating and impeding the recruitment and retention of older study participants and administered it to research staff. Enrollment-to-surgery ratios, missed visit rates, and dropout rates for older and younger participants were compared using Fisher's exact test, with cut-points of 70 and 80 years for the CARE and Colpocleisis studies, respectively.Results: Questionnaires were completed by 23 physician investigators and 11 nurses or coordinators (92% response rate). Respondents indicated it was more difficult to recruit older research participants (32%), obtain informed consent (56%), and retain participants to study completion (50%). Challenges to recruitment included caregiver involvement in the decision to participate and participant comorbidities. Perceived barriers to retention were transportation, caregiver availability, and participant fatigue. Data quality was challenged by sensory and cognitive impairment, resulting in a change from telephone interviews to in-person visits in the Colpocleisis study. Older participants did not have higher dropout rates than younger participants. There were no differences in missed in-person visits or telephone interview rates between age groups.Conclusions: Strategies, albeit unstudied, could assist investigators in planning surgical trials that successfully enroll and retain older women. [ABSTRACT FROM AUTHOR]

Background: Although studies suggest that optimism can predict health outcomes, the relationship has not been tested in women with pelvic organ prolapse (POP). This study sought to explore the relationship between optimism, prolapse severity, and symptoms before operation; and examine whether optimism predicts postsurgical functional status, treatment satisfaction, and treatment success.Study Design: Data from the randomized Colpopexy and Urinary Reduction Efforts (CARE) study, in which stress continent women undergoing sacrocolpopexy to repair stage II to IV POP completed a baseline assessment of optimism and validated symptom and quality-of-life measures at baseline and 24 months. Relationships between optimism and demographics, clinical status, and functional and quality-of-life outcomes were assessed.Results: Of 322 Colpopexy and Urinary Reduction Efforts study participants, 305 (94.7%) completed 24-month followup interviews. At baseline, there were no notable differences in optimism with respect to POP stage or history of earlier operations for prolapse or urinary incontinence. At baseline, women with greater optimism reported markedly better physical and mental functioning (p Conclusions: In women planning operation for POP, optimism is related to pelvic symptom severity, but is not associated with satisfaction with treatment or treatment success. Abdominal sacrocolpopexy resulted in substantial improvements in quality of life and functional outcomes that were not notably influenced by optimism. [ABSTRACT FROM AUTHOR]

Importance: Urinary tract infection (UTI) is the most common bacterial infection for which empiric antibiotics are prescribed despite limited progression to urosepsis. More than half of antibiotics prescribed to older adults for a suspected UTI are considered unnecessary., Objective: The aim of the study was to assess knowledge, attitudes, and practices regarding management of older women (>65 years) with symptoms attributed to UTIs among family and internal medicine providers., Study Design: This cross-sectional study surveyed 330 primary care providers in November 2021 regarding management of UTI symptoms. The primary outcome was the proportion of primary care providers who felt safe waiting for urine culture results before prescribing antibiotics in older women., Results: The response rate was 43.0% (n = 142) with the majority of primary care providers practicing medicine more than 15 years (56.3%). For the primary outcome, 26.1% (n = 37) of primary care providers felt safe waiting for a urine culture result before prescribing antibiotics, while 62.0% (n = 88) felt delaying antibiotics depended on multiple factors, and 9.2% (n = 13) felt it was never safe to delay antibiotics. Primary care providers that either never felt it was safe to delay antibiotics or felt that "it depends" on a variety of factors, attributed their antibiotics administration to concern for progression to sepsis (n = 50, 49.5%) or progression of symptoms (n = 28, 27.7%). A higher proportion of primary care providers practicing more than 15 years felt safe delaying antibiotics compared with primary care providers with less experience (33.8% vs 18.3%, P = 0.04), and 70.3% of those who felt safe delaying antibiotics had more than 15 years of experience., Conclusion: Primary care providers with more clinical experience have more comfort delaying antibiotics in older women with UTI symptoms., Competing Interests: The authors have declared they have no conflicts of interest., (Copyright © 2023 American Urogynecologic Society. All rights reserved.)

Importance: Despite the prevalence of asymptomatic bacteriuria (ASB), what proportion of the population is aware of this condition and the quality of internet resources are currently unknown., Objective: This study aimed to use an online crowdsourcing platform to explore general knowledge and internet search strategies, along with the quality of information, on ASB., Study Design: An online survey was administered through a crowdsourcing platform to women 50 years or older via Qualtrics, which is a sophisticated online survey tool. Participants completed a survey on ASB, and participants were asked how they would search the internet for information both on urinary test results and on ASB. Outcomes included survey responses, and qualitative data were coded and analyzed thematically. χ2 Testing and regression modeling were used to look for variables associated with concern for ASB., Results: There were a total of 518 participants who passed attention check qualifications, and only 45 respondents (8.7%) had heard of ASB. Many were concerned about progress to a worsening infection (n = 387 [77.6%]). When controlling for confounders, education beyond a college degree was not associated with a lower concern for ASB when compared with those with a high school education or less (adjusted odds ratio, 0.63; 95% confidence interval, 0.25-1.55; P = 0.31). Medical providers were the target audience for a majority of the websites, and many of the patient-facing results were of poor quality., Conclusions: Our national survey of women demonstrated a prevalent knowledge deficit surrounding ASB. We must seek to create high-quality, readily available, patient-facing information to increase awareness of ASB, allay concerns, and increase antibiotic stewardship., Competing Interests: Megan S. Bradley reports grant funding from Axonics. The remaining authors report no conflicts of interest., (Copyright © 2024 American Urogynecologic Society. All rights reserved.)

Introduction and Hypothesis: Urinary tract infections (UTIs) are one of the most common bacterial infections in women. We hypothesized that over half of those treated empirically would receive inappropriate antibiotics, those treated expectantly would have lower symptom improvement without antibiotics, and that overall progression to sequelae would be uncommon., Methods: In this retrospective cohort study of women with UTI symptoms, we quantified the proportion who received inappropriate antibiotics in those treated empirically, defined as those with a negative urine culture or antibiotics that were changed according to culture sensitivities, and identified factors associated with symptom improvement during expectant management. Secondarily, we sought to determine the proportion of UTI sequelae in both groups. During the study time frame, a modified UTI Symptom Assessment (UTISA) questionnaire was administered at baseline and again, with a global rating for change instrument, when urine culture results were relayed., Results: Analyses included 152 women, mean age 66.5 (SD 15.0) years, 30 (20%) received empiric antibiotics, and 122 (80%) expectant management. At baseline, the empiric group reported greater mean scores for dysuria (p < 0.01), urgency (p < 0.01), frequency (p < 0.01), and incomplete emptying (p < 0.01). Positive culture results were reported for 16 (53%) in the empiric group and 72 (59%) in the expectant group. Inappropriate antibiotics were prescribed to 18 (60%) of the empiric group. A negative urine culture was associated with improvement in symptoms in the expectant group. No subjects experienced UTI sequelae within 30 days of initial evaluation., Conclusion: In our cohort of older women with UTI symptoms, deferring antibiotics until urine culture  resulted appeared to be safe and decreased the use of inappropriate antibiotics., (© 2023. The International Urogynecological Association.)

Objectives: To compare treatment response in women who did and did not develop a urinary tract infection (UTI) within 14 days after intravesical onabotulinumtoxinA injections for treatment of refractory urgency urinary incontinence (UUI)., Methods: This is a secondary analysis of women who received Onabotulinumtoxin A in the Refractory Overactive Bladder: Sacral Neuromodulation vs Botulinum Toxin Assessment (ROSETTA) Trial. Participants were grouped by presence or absence of UTI within 14 days of injection. UTI was defined as symptomatic with positive urine culture per the primary ROSETTA protocol. Our primary outcome was change from baseline in mean number of UUI episodes based on monthly 3-day bladder diaries averaged over 6 months. We performed t tests and chi-square/Fisher's exact for continuous and categorical variables. A p value of <0.05 was considered statistically significant., Results: Of 187 participants in the onabotulinumtoxinA arm, 10 (5.3%) experienced UTI within 14 days of injection, and 177 (94.7%) did not. At baseline, groups did not differ in demographics, mean UUI episodes per day (no UTI [5.37 ± 2.65] vs. UTI [6.40 ± 3.02], p = 0.24), or other diary parameters. For our primary outcome, groups did not differ in the change in mean daily UUI episodes at 1 month (no UTI [-4.29 ± 2.75] vs. UTI [-3.74 ± 2.01]; mean difference [95% confidence interval, CI] -0.55 [-2.39 to 1.28], p: 0.55) or 6 months (no UTI [-3.63 ± 2.89] vs. UTI [-2.15 ± 3.18]; mean difference [95% CI] -1.48 [-3.44 to 0.48], p: 0.14)., Conclusions: UTI within 14 days after intravesical injection of onabotulinumtoxinA for refractory UUI was not significantly associated with inferior treatment response at 1 or 6 months., (© 2023 Wiley Periodicals LLC.)

Importance: Although anatomic level of mesh attachment to the sacrum varied during minimally invasive sacrocolpopexy with a large proportion above S1, this was not associated with pelvic organ prolapse recurrence., Objective: This study aimed to describe the anatomic level of sacral mesh attachment and its association with prolapse recurrence after minimally invasive sacrocolpopexy., Study Design: This study included a retrospective cohort of women who underwent minimally invasive sacrocolpopexy with subsequent abdominal and pelvic imaging (magnetic resonance imaging or computed tomography) between 2010 and 2019 at a single academic institution. Anatomic level of attachment was determined by a radiologist. Prolapse recurrence was defined as a composite of self-reported bulge symptoms, any prolapse measure beyond the hymen, and any retreatment with pessary or surgery. χ 2 Tests were used for comparative outcomes., Results: Analyses included 212 women. The mean ± SD age was 58.8 ± 9.9 years, the majority have preoperative stage III/IV prolapse (81.1%), and the median follow-up was 269 days (interquartile range, 57-825 days). Mesh was attached using titanium tacks (n = 136 [64.2%]) and suture (n = 76 [35.8%]) at the level of the L5-S1 intervertebral space (n = 113 [53.3%]) or overlying S1 (n = 89 [42.0%]).The surgical approach was significantly associated with attachment location with a greater proportion of laparoscopy cases demonstrating mesh attachment above S1 (85 [62.5%] vs robotically, 30 [39.5%]; P < 0.01). Dichotomized level of attachment was not associated with composite prolapse recurrence (above S1, n = 18 [22.2%] vs below S1, n = 24 [24.7%]; P = 0.69) or any compartment recurrence ( P ≥ 0.36)., Conclusions: Mesh was primarily attached to the anterior longitudinal ligament at the level of the L5-S1 intervertebral space or S1. Level of mesh attachment was not associated with composite prolapse recurrence., Competing Interests: The authors have declared they have no conflicts of interest., (Copyright © 2022 American Urogynecologic Society. All rights reserved.)

Importance: Acute postoperative urinary retention (POUR) is common after pelvic reconstructive surgery, occurring in 15-45% of women. There is a paucity of data on the relationship between frailty and POUR after prolapse surgery., Objective: This study aimed to examine the association between frailty and POUR in older women who underwent pelvic organ prolapse surgery., Study Design: This secondary analysis of a prospective study of postoperative delirium enrolled women 60 years and older undergoing prolapse surgery. The Fried Frailty Index was used to assess frailty before surgery. Acute POUR was defined as failure to pass a retrograde voiding trial at hospital discharge with postvoid residual volume of greater than 100 mL., Results: Analyses included 165 women, with a mean ± SD age of 72.5 ± 6.1 years and a body mass index of 28.0 ± 4.4 kg/m2. There were 49 laparoscopic/robotic apical suspension procedures (29.7%), 60 vaginal obliterative procedures (36.4%), 47 vaginal apical suspension procedures (28.5%), and 9 isolated anterior and/or posterior colporrhaphies (5.5%), of which 9 had a concomitant incontinence procedure. Seventy-eight women (47.3%) experienced acute POUR. Thirty-one (18.8%) met the criteria for "not frail," 115 (88.5%) were "prefrail," and 19 (11.5%) were "frail." Neither frailty status nor score was associated with POUR. In an analysis of individual Fried Frailty Index components, self-reported unintentional weight loss was significantly associated with POUR (odds ratio, 4.6; 95% confidence interval, 1.23-17.15). This remained significant on multivariable logistic regression (adjusted odds ratio, 4.06; 95% confidence interval, 1.01-16.39)., Conclusions: Frailty was not associated with POUR in older women undergoing prolapse surgery. The observed association between POUR and unintended weight loss before surgery warrants further investigation., Competing Interests: M.F.A. is supported by the National Institute on Aging (R03AG064378-01, K23AG073517-01) and the Pennsylvania Department of Health (4100088553). M.F.A.'s spouse is employed by Johnson & Johnson Corporate. The rest of the authors have declared no conflict of interest., (Copyright © 2023 American Urogynecologic Society. All rights reserved.)

Introduction and Hypothesis: To determine the 7-day incidence and risk factors of postoperative delirium (POD) occurring after prolapse surgery in women aged ≥60 years., Methods: A prospective study of women ≥60 years undergoing prolapse surgery at a large academic center. The primary outcome is positive Confusion Assessment Method delirium screen administered in person or by telephone at the time of hospital discharge and postoperative days 1, 3, 5, and 7., Results: This analysis included 165 patients, mean ± SD age of 72.5 ± 6.1 years, with median (IQR) years of education of 13 (12-16), and baseline Modified Mini-Mental Status (3MS) Exam score of 95 (92-98). Prolapse repair type was vaginal for 70% (n=115) and laparoscopic for 30% (n=50) of patients; most under general anesthesia, 151 (92.1%). The incidence of positive delirium screen during the first week after surgery was 12.1% (n=20). Most of these participants screened positive on postoperative day 0, 8.4% (n=14). In univariate analyses, a positive screen was associated with older age and fewer education years, lower 3MS exam score, greater baseline geriatric depression scale score, and greater frailty score. Lower 3MS score was the only variable that remained significant in the final model (adjusted odds ratio 0.84, 95% CI 0.75-0.95)., Conclusions: One in 12 women ≥60 years deemed eligible for discharge on the day of prolapse surgery screens positive for delirium. The 7-day POD incidence is comparable to other elective non-cardiac surgery cohorts. Given the increasing trend toward same day discharge after major prolapse surgery, more research is needed to determine the impact of universal delirium screening as part of discharge assessments., (© 2022. The International Urogynecological Association.)

Background: Among women with symptomatic uterovaginal prolapse undergoing vaginal surgery in the Vaginal hysterectomy with Native Tissue Vault Suspension vs Sacrospinous Hysteropexy with Graft Suspension (Study for Uterine Prolapse Procedures Randomized Trial) trial, sacrospinous hysteropexy with graft (hysteropexy) resulted in a lower composite surgical failure rate than vaginal hysterectomy with uterosacral suspension over 5 years., Objective: This study aimed to identify factors associated with the rate of surgical failure over 5 years among women undergoing sacrospinous hysteropexy with graft vs vaginal hysterectomy with uterosacral suspension for uterovaginal prolapse., Study Design: This planned secondary analysis of a comparative effectiveness trial of 2 transvaginal apical suspensions (NCT01802281) defined surgical failure as either retreatment of prolapse, recurrence of prolapse beyond the hymen, or bothersome prolapse symptoms. Baseline clinical and sociodemographic factors for eligible participants receiving the randomized surgery (N=173) were compared across categories of failure (≤1 year, >1 year, and no failure) with rank-based tests. Factors with adequate prevalence and clinical relevance were assessed for minimally adjusted bivariate associations using piecewise exponential survival models adjusting for randomized apical repair and clinical site. The multivariable model included factors with bivariate P<.2, additional clinically important variables, apical repair, and clinical site. Backward selection determined final retained risk factors (P<.1) with statistical significance evaluated by Bonferroni correction (P<.005). Final factors were assessed for interaction with type of apical repair at P<.1. Association is presented by adjusted hazard ratios and further illustrated by categorization of risk factors., Results: In the final multivariable model, body mass index (increase of 5 kg/m 2 : adjusted hazard ratio, 1.7; 95% confidence interval, 1.3-2.2; P<.001) and duration of prolapse symptoms (increase of 1 year: adjusted hazard ratio, 1.1; 95% confidence interval, 1.0-1.1; P<.005) were associated with composite surgical failure, where rates of failure were 2.9 and 1.8 times higher in women with obesity and women who are overweight than women who have normal weight and women who are underweight (95% confidence intervals, 1.5-5.8 and 0.9-3.5) and 3.0 times higher in women experiencing >5 years prolapse symptoms than women experiencing ≤5 years prolapse symptoms (95% confidence interval, 1.8-5.0). Sacrospinous hysteropexy with graft had a lower rate of failure than hysterectomy with uterosacral suspension (adjusted hazard ratio, 0.6; 95% confidence interval, 0.4-1.0; P=.05). The interaction between symptom duration and apical repair (P=.07) indicated that failure was less likely after hysteropexy than hysterectomy for those with ≤5 years symptom duration (adjusted hazard ratio, 0.5; 95% confidence interval, 0.2-0.9), but not for those with >5 years symptom duration (adjusted hazard ratio, 1.0; 95% confidence interval 0.5-2.1)., Conclusion: Obesity and duration of prolapse symptoms have been determined as risk factors associated with surgical failure over 5 years from transvaginal prolapse repair, regardless of approach. Providers and patients should consider these modifiable risk factors when discussing treatment plans for bothersome prolapse., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Importance: This study assesses resting genital hiatus (GH) measurements under anesthesia as compared with in-office measurements for intraoperative planning purposes., Objectives: The aim of this study was to determine the influence of general anesthesia and apical suspension on GH measurements compared with office measurements., Study Design: This was a retrospective cohort of women who underwent minimally invasive sacrocolpopexy within an academic urogynecology practice. Genital hiatus for each patient was measured at 4 time points: (1) preoperative office examination (baseline) at rest (GH rest ) and with strain (GH strain ); (2) following anesthesia induction, at rest (GH induction ); (3) immediately after sacrocolpopexy, at rest (GH colpopexy ); and (4) 4- to 6-week postoperative visit, strain (GH postop ). Enlarged baseline GH strain was defined as ≥4 cm. Paired statistics and analysis of variance were used for comparisons., Results: Fifty-one women were included, whose mean age was 61.3 ± 8.2 years; the majority had stage ≥3 prolapse (n = 39 [76.4%]). Concomitant procedures included hysterectomy (n = 33 [64.7%]) and posterior colporrhaphy or perineorrhaphy (n = 8 [15.7%]). The majority had an enlarged baseline GH strain (n = 39 [76.4%]), and overall cohort mean was 4.7 ± 1.3 cm. Compared with baseline GH rest , mean GH induction was larger (GH induction : 4.6 ± 1.4 cm vs GH rest : 3.8 ± 1.2 cm, P < 0.01) but not different from baseline GH strain (GH induction : 4.6 ± 1.4 cm vs GH strain : 4.7 ± 1.3 cm, P = 0.81). GH colpopexy was decreased from baseline GH strain with a mean difference of 1.1 ± 1.3 cm ( P < 0.01). This difference was driven by women with enlarged baseline GH strain who experienced a mean decrease of 1.5 ± 1.1 cm ( P < 0.01)., Conclusions: Genital hiatus after induction of anesthesia does not significantly differ from preoperative straining GH. Apical suspension with sacrocolpopexy alone resulted in immediate reduction in GH measures, with greater decreases observed in women with enlarged preoperative GH., Competing Interests: The authors have declared they have no conflicts of interest., (Copyright © 2022 American Urogynecologic Society. All rights reserved.)

Importance: Urinary tract infections (UTIs) are one of the most common bacterial infections and more frequently affect women than men., Objectives: Our objective was to determine clinical characteristics associated with a positive urine culture in women seeking treatment for symptoms of UTI., Study Design: In this prospective cohort study, women seeking treatment for UTI symptoms were administered the Urinary Tract Infection Symptom Assessment questionnaire at baseline and at the time of culture results. Participants were grouped by history of recurrent UTI (rUTI) based on chart review. Our primary outcome was the proportion of "positive" urine cultures (≥10 3 colony-forming units) compared between rUTI groups. Characteristics were compared and the relative odds of a positive culture were calculated with a logistic regression model., Results: Analyses included 152 women, 79 (52%) with rUTI and 73 (48%) with no history of rUTI. Overall, 90 (59.2%) had a positive culture. Participants with a positive culture were more likely to report history of rUTI ( P = 0.01). There was a 2.45-fold increased adjusted odds of a positive culture in those with a history of rUTI (adjusted odds ratio [aOR], 2.45; 95% confidence interval [CI], 1.34-5.03; P = 0.01) when controlling for confounding variables, including scores on the Urinary Tract Infection Symptom Assessment for frequency (aOR, 0.59; 95% CI, 0.40-0.91), dysuria (aOR, 1.53; 95% CI, 1.10-2.12), and age (aOR, 1.02; 95% CI, 1.01-1.05)., Conclusions: In a cohort of women seeking care for UTI symptoms, older women, those with a history of rUTI and those presenting with dysuria are more likely to have a positive urine culture compared with those with urinary frequency., Competing Interests: H.Z. discloses that she was a member of the Board of Directors of the American College of Obstetricians and Gynecologists. M.S.B. discloses Axonics and Hologic Research Support. The remaining authors have declared they have no conflicts of interest., (Copyright © 2022 American Urogynecologic Society. All rights reserved.)

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., (Copyright © 2022 by The American College of Gastroenterology.)

Importance: Many health care providers place concomitant midurethral slings during pelvic organ prolapse repair, yet growing evidence supports staged midurethral sling placement., Objectives: The aim of this study was to compare urinary function after transvaginal uterovaginal prolapse repair with and without midurethral sling., Study Design: Secondary analysis of the Study of Uterine Prolapse Procedures Randomized Trial (hysterectomy with uterosacral ligament suspension vs mesh hysteropexy). Our primary outcome was Urinary Distress Inventory score (UDI-6) through 5 years compared between women with and without a concomitant sling within prolapse repair arms. Sling effect was adjusted for select clinical variables and interaction terms (α = .05)., Results: The sling group included 90 women (43 hysteropexy, 47 hysterectomy), and the no-sling group included 93 women (48 hysteropexy, 45 hysterectomy). At baseline, the sling group reported more bothersome stress (66% vs 36%, P < 0.001) and urgency incontinence (69% vs 48%, P = 0.007). For hysteropexy, there were no significant long-term differences in UDI-6 scores or bothersome urine leakage between sling groups. For hysterectomy, women with sling had better UDI-6 scores across time points (adjusted mean difference, -5.1; 95% confidence interval [CI], -9.9 to -0.2); bothersome stress and urgency leakage were less common in the sling group (stress adjusted odds ratio, 0.1 [95% CI, 0.0-0.4]; urge adjusted odds ratio, 0.5 [95% CI, 0.2-1.0]). Treatment for stress incontinence over 5 years was similar in the sling (7.9%) versus no-sling (7.6%) groups., Conclusions: Five-year urinary outcomes of concomitant midurethral sling may vary by type of transvaginal prolapse surgery, with possible benefit of midurethral sling at the time of vaginal hysterectomy with apical suspension but not after mesh hysteropexy., (Copyright © 2022 American Urogynecologic Society. All rights reserved.)

Objectives: High-level evidence for second-line noninvasive treatments for fecal incontinence in women is limited. We present the rationale for and design of the NeuromOdulaTion for Accidental Bowel Leakage trial, a randomized controlled trial of percutaneous tibial nerve stimulation (PTNS) and validated sham stimulation in women with refractory accidental bowel leakage., Methods: The rationale and goals for a 2-part study with a run-in phase, use of a generic pulse generator for PTNS and sham stimulation, masking, participant inclusion, primary and secondary outcome measures, and adverse event collection are described. A superiority design will be used to compare change from baseline in St. Mark's score after 12 weekly stimulation sessions between PTNS and sham. Responders to initial treatment (PTNS or sham) will be assigned to scheduled or "as needed" intervention for up to 1 year. Secondary outcome measures include incontinence episodes and other bowel events recorded in a 14-day electronic bowel diary, general and condition-specific quality of life instruments, adaptive behavior, global impression of improvement, symptom control, and sexual function., Results: Sample size calculations determined that 165 participants (110 PTNS and 55 sham) would provide 90% power to detect greater than or equal to 4-point difference between PTNS and sham in change from baseline in St. Mark's score at 12 weeks., Conclusions: The methods for the NeuromOdulaTion for Accidental Bowel Leakage trial will provide high-level evidence of the effectiveness and optimal maintenance therapy schedule of a low-cost PTNS protocol in community-dwelling women seeking second-line intervention for refractory accidental bowel leakage., Competing Interests: The authors have declared they have no conflicts of interest., (Copyright © 2021 American Urogynecologic Society. All rights reserved.)

Objective: The incidence and associated risk factors for sacral osteomyelitis and sacral discitis after sacrocolpopexy remain unknown. The aim of this study was to determine the incidence of sacral osteomyelitis and discitis after minimally invasive sacrocolpopexy and their association with the method of sacral mesh fixation., Methods: This is a retrospective cohort study of consecutive minimally invasive sacrocolpopexies performed by 11 female pelvic medicine and reconstructive surgery board-certified surgeons from January 2009 to August 2019 within a single health system. Sociodemographic, procedure, and clinical variables were abstracted from the electronic health record (EHR). We then performed a confirmatory EHR interrogation, cross-referencing procedural codes for laparoscopic and robot-assisted sacrocolpopexy and diagnostic codes for sacral osteomyelitis and sacral discitis., Results: The EHR chart review identified 1,189 women who underwent laparoscopic (55.2%) and robot-assisted (44.8%) minimally invasive sacrocolpopexy, all with polypropylene mesh. Median follow-up was 7.7 months (interquartile range, 0-49.8). Titanium helical tacks were used in 52.7% patients, sutures in 41.6%, and both in 5.6%. No cases (0%) of sacral osteomyelitis or discitis were identified by chart review. The system-wide EHR interrogation of procedural and diagnostic codes identified 421 additional procedures for a total of 1,610 minimally invasive sacrocolpopexies. Among these, there were no cases (0%) of osteomyelitis or discitis., Conclusions: Sacral osteomyelitis and discitis are rare early outcomes after minimally invasive sacrocolpopexy with an incidence of less than 1/1,000 cases. Given an absence of cases, we were unable to assess for an association between method of sacral attachment and sacral osteomyelitis and sacral discitis., Competing Interests: The authors have declared they have no conflicts of interest., (Copyright © 2021 American Urogynecologic Society. All rights reserved.)

Objective: As perioperative care pathways are developed to improve recovery, there is a need to explore the impact of age. The aim of this study was to compare the impact of a urogynecology-specific enhanced recovery after surgery (ERAS) pathway on perioperative outcomes across 3 age categories: young, middle age, and elderly., Methods: A retrospective cohort study was conducted assessing same-day discharge, opioid administration, pain scores, and complications differences across and within 3 age categories, young (<61 years), middle age (61-75 years), elderly (>75 years), before and after ERAS implementation., Results: Among 98 (25.7%) young, 202 (52.9%) middle-aged, and 82 (21.5%) elderly women, distribution before and after ERAS implementation was similar. In each age category, we found a commensurate increase in same-day discharge and decrease in length of stay independent of age. Age was associated with a variable response to opioid administration after ERAS. In women who received opioids, we found there was a greater reduction in opioids in elderly. Young women received 22.5 mg more than middle-aged women, whereas elderly women received 24.3 mg less than middle-aged women (P < 0.0001, P < 0.0001) for a mean difference of 46.8 mg between the youngest and oldest group. We found no significant differences in postanesthesia care unit pain scores with ERAS implementation. Complications did not increase after ERAS implementation in any age group, although younger and elderly women were more likely to experience complications independent of ERAS., Conclusions: Elderly women had similar outcomes compared with their younger counterparts after implementation of an ERAS pathway. Further research is needed to assess whether our age-related observations are generalizable., Competing Interests: The authors have declared they have no conflicts of interest., (Copyright © 2020 American Urogynecologic Society. All rights reserved.)

Objective: The aim of the study was to determine the performance of a previously published stress urinary incontinence (SUI) risk calculator in women undergoing minimally invasive or transvaginal apical suspensions., Methods: Using a database of stress-continent women who underwent minimally invasive or transvaginal apical suspensions, we calculated 2 prediction risks for development of SUI within 12 months based on inclusion of a "prophylactic" midurethral sling at the time of prolapse surgery. Observed subjective and objective continence status was abstracted from medical records. Regression models were created for the outcome of de novo SUI to generate receiver operating curves. Concordance (c) indices were estimated for the overall and procedure subgroups to determine the calculator's ability to discriminate between SUI outcomes., Results: Analyses included 502 women. De novo SUI was observed in 23.5% of women. The mean ± SD calculated risk of de novo SUI if a sling was performed was 18.9% ± 13.9 at 12 months compared with 36.4% ± 8.3 without sling. The calculator's discriminative ability for those with a planned sling was moderate (c-index = 0.55, P = 0.037). The calculator failed to discriminate continence outcomes when a sling was not planned in the overall group (c-index = 0.50, P = 0.799) and individual apical procedures., Conclusions: The SUI risk calculator is significantly limited in its ability to predict de novo SUI in our population of women planning minimally invasive apical suspensions. Refinements to the calculator model are needed to improve its utility in clinical practice., (Copyright © 2019 American Urogynecologic Society. All rights reserved.)

Objective: We present the rationale for and the design of a prospective trial to evaluate the role of preoperative frailty and mobility assessments in older women undergoing surgery for the treatment of pelvic organ prolapse (POP) as a planned prospective supplemental trial to the ASPIRe (Apical Suspension Repair for Vault Prolapse In a Three-Arm Randomized Trial Design) trial. The Frailty ASPIRe Study (FASt) examines the impact of preoperative frailty and mobility on surgical outcomes in older women (≥65 years) participating in the ASPIRe trial. The primary objective of FASt is to determine the impact of preoperative age, multimorbidity, frailty, and decreased mobility on postoperative outcomes in older women (≥65 years old) undergoing surgery for POP., Methods: The selection of the preoperative assessments, primary outcome measures, and participant inclusion is described. Frailty and mobility measurements will be collected at the preoperative visit and include the 6 Robinson frailty measurements and the Timed Up and Go mobility test. The main outcome measure in the FASt supplemental study will be moderate to severe postoperative adverse events according to the Clavien-Dindo Severity Classification., Conclusions: This trial will assess impact of preoperative age, multimorbidity, frailty, and decreased mobility on postoperative outcomes in older women (≥65 years old) undergoing surgical procedures for the correction of apical POP. Information from this trial may help both primary care providers and surgeons better advise/inform women on their individual risks of surgical complications and provide more comprehensive postoperative care to women at highest risk of complications., Competing Interests: E.E. receives grant funding from NIH/National Center for Advancing Translational Sciences NCATS KL2TR001088; S.M. receives honoraria from UpToDate is a board member of the American Urogynecologic Society; Y.M.K. receives grant funding and salary supported by National Institutes of Health (NIH)/National Center for Complementary and Integrative Health R01AT007171; C.A.F. receives unrestricted research grants from Coloplast, Inc, and Caldera, Inc, and royalties from UpToDate, Inc; D.D.R. receives grant funding and investigator-initiated research with Pfizer (study drug provided by company), R01 AG047290; D.M. is a government employee (NIH/NICHD); H.E.R. receives grant funding from NICHD/National Institute on Aging and Pelvalon, is consultant to Pelvalon, Bluewind, and Renovia, receives royalties from Up to Date, and is board member of the Society of Gynecologic Surgeons, World Wide Fistula Fund. The other authors have declared they have no conflicts of interest., (Copyright © 2020 American Urogynecologic Society. All rights reserved.)

Aims: To assess performance, acceptability, external validity, and reliability of a phone application electronic bowel diary (PFDN Bowel eDiary)., Methods: Women reporting refractory accidental bowel leakage (ABL) were enrolled in a randomized, crossover trial evaluating paper versus eDiary documentation of bowel movements (BM) and fecal incontinence episodes (FIE). Events were characterized by the presence or absence of urgency and Bristol stool scale consistency. The eDiary entries were date/time stamped and prompted by twice-daily phone notifications. Women were randomized to complete up to three consecutive 14-day diaries in two sequences. Diary events were compared between formats using the Pearson correlation. System usability scale (SUS) assessed eDiary usability. The eDiary test-retest reliability was assessed with intraclass correlations (ICCs)., Results: Paired diary data were available from 60/69 (87%) women 63.8 ± 9.8 years old with mean 13.2 BM per week and 6.5 FIE per week (nearly half with urgency). Among those providing diaries, adherence did not differ by paper or eDiary (93.3% vs. 95.0%). Notifications prompted 29.6% of eDiary entries, improving adherence from 70% to 95%. Paper and eDiaries were moderate to-strongly correlated for BMs per week (r = .61), urgency BMs per week (r = .76), FIE per week (r = .66), urgency FIE per week (r = .72). Test-retest reliability was good (ICC = .81 BMs per week, .79 urgency BMs per week, .74 FIE per week, and .62 urgency FIE per week). The mean SUS score was high, 82.3 ± 17.5 (range, 0-100) with 91.4% rating it easy to use, and 75.9% preferring the eDiary over paper., Conclusion: The PFDN Bowel eDiary correlated well with paper diary was considered easy to use, preferred to paper diaries, had high rates of confirmed real-time diary completion that obviated staff data entry., (© 2020 Wiley Periodicals LLC.)

Background: Well designed, large comparative effectiveness trials assessing the efficacy of primary interventions for faecal incontinence are few in number. The objectives of this study were to compare different combinations of anorectal manometry-assisted biofeedback, loperamide, education, and oral placebo., Methods: In this randomised factorial trial, participants were recruited from eight clinical sites in the USA. Women with at least one episode of faecal incontinence per month in the past 3 months were randomly assigned 0·5:1:1:1 to one of four groups: oral placebo plus education only, placebo plus anorectal manometry-assisted biofeedback, loperamide plus education only, and loperamide plus anorectal manometry-assisted biofeedback. Participants received 2 mg per day of loperamide or oral placebo with the option of dose escalation or reduction. Women assigned to biofeedback received six visits, including strength and sensory biofeedback training. All participants received a standardised faecal incontinence patient education pamphlet and were followed for 24 weeks after starting treatment. The primary endpoint was change in St Mark's (Vaizey) faecal incontinence severity score between baseline and 24 weeks, analysed by intention-to-treat using general linear mixed modelling. Investigators, interviewers, and outcome evaluators were masked to biofeedback assignment. Participants and all study staff other than the research pharmacist were masked to medication assignment. Randomisation took place within the electronic data capture system, was stratified by site using randomly permuted blocks (block size 7), and the sizes of the blocks and the allocation sequence were known only to the data coordinating centre. This trial is registered with ClinicalTrials.gov, number NCT02008565., Findings: Between April 1, 2014, and Sept 30, 2015, 377 women were enrolled, of whom 300 were randomly assigned to placebo plus education (n=42), placebo plus biofeedback (n=84), loperamide plus education (n=88), and the combined intervention of loperamide plus biofeedback (n=86). At 24 weeks, there were no differences between loperamide versus placebo (model estimated score change -1·5 points, 95% CI -3·4 to 0·4, p=0·12), biofeedback versus education (-0·7 points, -2·6 to 1·2, p=0·47), and loperamide and biofeedback versus placebo and biofeedback (-1·9 points, -4·1 to 0·3, p=0·092) or versus loperamide plus education (-1·1 points, -3·4 to 1·1, p=0·33). Constipation was the most common grade 3 or higher adverse event and was reported by two (2%) of 86 participants in the loperamide and biofeedback group and two (2%) of 88 in the loperamide plus education group. The percentage of participants with any serious adverse events did not differ between the treatment groups. Only one serious adverse event was considered related to treatment (small bowel obstruction in the placebo and biofeedback group)., Interpretation: In women with normal stool consistency and faecal incontinence bothersome enough to seek treatment, we were unable to find evidence against the null hypotheses that loperamide is equivalent to placebo, that anal exercises with biofeedback is equivalent to an educational pamphlet, and that loperamide and biofeedback are equivalent to oral placebo and biofeedback or loperamide plus an educational pamphlet. Because these are common first-line treatments for faecal incontinence, clinicians could consider combining loperamide, anal manometry-assisted biofeedback, and a standard educational pamphlet, but this is likely to result in only negligible improvement over individual therapies and patients should be counselled regarding possible constipation., Funding: Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health Office of Research on Women's Health., (Copyright © 2019 Elsevier Ltd. All rights reserved.)

Objective: To compare the effect of preoperative intravenous (IV) acetaminophen compared with placebo on pain scores after pelvic organ prolapse surgery., Methods: This double-blind placebo-controlled multicenter trial randomized women undergoing prolapse surgery to IV acetaminophen (1,000 mg) or preoperative saline stratified by surgical route (laparoscopic or vaginal). The primary outcome was the change from baseline in patient-reported visual analog scale pain scores at 24 hours after surgery. Secondary outcomes included narcotic use measured in morphine milligram equivalents, satisfaction and quality of life (QOL) using validated questionnaires on postoperative days 1 and 7, and overall side effects., Results: Between 2014 and 2017, 204 women were enrolled and primary-outcome data from 162 were analyzed. Women had a mean (±SD) age of 66±10 years, were predominantly Caucasian (96%) and postmenopausal (96%). Acetaminophen was administered to 52 of the 101 women undergoing vaginal surgery, and 50 of the 101 women undergoing laparoscopy. There were no overall or route of surgery differences in mean change from baseline pain scores at 24 hours between acetaminophen and placebo (overall 25±26 vs 21±24 mm; vaginal 29±28 vs 21±23 mm; laparoscopic 20±26 vs 21±25 mm). There were no differences in 24-hour morphine milligram equivalent narcotic use (overall 38±25 vs 40±25 mg; vaginal 32±24 vs 33±25 mg; laparoscopic 45±24 vs 47±24 mg). No differences were seen in patient satisfaction, QOL, or side effects, except for urinary retention., Conclusion: In women undergoing prolapse repair, preoperative IV acetaminophen did not reduce pain scores or opioid use and had no effect on patient satisfaction or QOL. Routine use of preemptive IV acetaminophen alone is not supported by this study., Clinical Trial Registration: ClinicalTrials.gov, NCT02155738.

Introduction and Hypothesis: Studies have yet to examine the impact of day-of-surgery voiding trials on post-operative urinary retention in women undergoing obliterative and apical suspension procedures for pelvic organ prolapse. Our objective was to evaluate if time to spontaneous void after these procedures is shorter when a voiding trial is performed on the day of surgery compared with our standard practice of post-operative day 1., Methods: We conducted a randomized, parallel-arm trial in patients undergoing major pelvic floor reconstructive surgery. Women were randomized 1:1 to an early (4 h post-operatively on the day of surgery) or a standard (6 am on post-operative day 1) retrograde voiding trial., Results: A total of 57 women consented. Mean age and BMI were 65 ± 11 and 27.9 ± 4.4. Most women had stage III pelvic organ prolapse (77.2%). Groups had similar baseline characteristics. In the intention-to-treat analysis (n = 57), there was no difference in time to spontaneous void in the early versus standard voiding trial groups (15.9 ± 3.8 vs 28.4 ± 3.1 hours, p = 0.081). In the adjusted analysis using mutlivariable linear regression, an early voiding trial decreased the time to spontaneous void (abeta -2.00 h, p = 0.031) when controlling for vaginal packing and stage IV prolapse. In the per-protocol analysis, which excluded 4 patients for crossover, spontaneous void occurred 17 hours faster in the early voiding trial group (14.6 ± 3.7 vs 31.8 ± 2.9 hours; p = 0.022). Early voiding trial patients experienced ambulation sooner and more often than the standard group (p = 0.02)., Conclusions: A day-of-surgery voiding trial did not prolong catheter use after obliterative and apical suspension procedures.

Women seeking relief from symptoms of stress urinary incontinence (SUI) may choose from a broad array of treatment options. Therapies range from lifestyle/behavioral modification to surgical interventions, and differ in terms of both effectiveness and risk. Individualized treatment plans can be developed to address a patient's expectations and goals for treatment, as well as her tolerance for potential adverse events. This article reviews the highest-quality clinical trials comparing contemporary treatment options for women with SUI. Clinicians and patients can use this compendium to inform their treatment selection., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Purpose: Few studies have characterized longer-term outcomes after retropubic and transobturator mid urethral slings., Materials and Methods: Women completing 2-year participation in a randomized equivalence trial who had not undergone surgical re-treatment for stress urinary incontinence were invited to participate in a 5-year observational cohort. The primary outcome, treatment success, was defined as no re-treatment or self-reported stress incontinence symptoms. Secondary outcomes included urinary symptoms and quality of life, satisfaction, sexual function and adverse events., Results: Of 597 women 404 (68%) from the original trial enrolled in the study. Five years after surgical treatment success was 7.9% greater in women assigned to the retropubic sling compared to the transobturator sling (51.3% vs 43.4%, 95% CI -1.4, 17.2), not meeting prespecified criteria for equivalence. Satisfaction decreased during 5 years but remained high and similar between arms (retropubic sling 79% vs transobturator sling 85%, p=0.15). Urinary symptoms and quality of life worsened with time (p <0.001), and women with a retropubic sling reported greater urinary urgency (p=0.001), more negative impact on quality of life (p=0.02) and worse sexual function (p=0.001). There was no difference in the proportion of women experiencing at least 1 adverse event (p=0.17). Seven new mesh erosions were noted (retropubic sling 3, transobturator sling 4)., Conclusions: Treatment success decreased during 5 years for retropubic and transobturator slings, and did not meet the prespecified criteria for equivalence with retropubic demonstrating a slight benefit. However, satisfaction remained high in both arms. Women undergoing a transobturator sling procedure reported more sustained improvement in urinary symptoms and sexual function. New mesh erosions occurred in both arms over time, although at a similarly low rate., (Copyright © 2015 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

OBJECTIVES: (1) to describe sexual function in women seeking treatment of stress urinary incontinence (SUI); (2) to compare the impact on sexual function of three SUI treatments; and (3) to investigate whether non-surgical treatment of SUI is associated with improved sexual function. METHODS: Women with SUI were randomized to continence pessary, behavioral therapy (pelvic floor muscle training and continence strategies), or combination therapy. Sexual function was assessed at baseline and 3-months using short forms of the Pelvic Organ Prolapse-Urinary Incontinence Sexual Function Questionnaire (PISQ-12) and the Personal Experiences Questionnaire (SPEQ). Successful treatment of SUI was assessed with a patient global impression of improvement. ANOVA was used to compare scores between groups. RESULTS: At baseline, sexual function was worse among women with mixed incontinence compared to those with pure SUI. After therapy, successful treatment of SUI was associated with greater improvement in PISQ-12 score (2.26 ± 3.24 versus 0.48 ± 3.76, p=0.0007), greater improvement in incontinence with sexual activity (0.45 ± 0.84 versus 0.01 ± 0.71, p=0.0002), and greater reduction in restriction in sexual activity related to fear of incontinence (0.32 ± 0.76 versus -0.06 ± 0.78, p=0.0008). Among those successfully treated for SUI, improvement in continence during sexual activity was greater in both the combined therapy group (p=0.019) and the behavioral group (p=0.02) compared to the pessary group. CONCLUSIONS: Successful non-surgical treatment of SUI is associated with improvements in incontinence-specific measures of sexual function. Behavioral therapy may be preferred to pessary for treatment of SUI among women whose incontinence interferes with sexual function.

Background: Non-surgical treatment for stress urinary incontinence (SUI) is recommended as first-line therapy, yet few prospective studies and no randomized trials compare the most common non-surgical treatments for SUI., Purpose: To present the design and methodology of the ambulatory treatments for leakage associated with stress (ATLAS) trial, a randomized clinical trial comparing three interventions for predominant SUI in women: intravaginal continence pessary; behavioral therapy (including pelvic floor muscle training and exercise and bladder control strategies); and a combination of the two treatments., Methods: Treatment outcome measures, collected at 12 weeks and six and 12 months post randomization, include the Patient Global Impression of Improvement (PGI-I), the Stress Incontinence Scale of the Pelvic Floor Distress Inventory (PFDI), seven-day bladder diaries, Pelvic Floor Impact Questionnaire (PFIQ), Pelvic Organ Prolapse-Urinary Incontinence Sexual Function Questionnaire (PISQ-12), Patient Satisfaction Questionnaire (PSQ) and the Medical Outcomes Study Short Form Health Survey (SF-36)., Limitations: The study design reduces most common biases, but some degree of selection bias may remain., Conclusion: This trial will provide useful information to help counsel women with stress and mixed incontinence about the relative efficacy and satisfaction with pessary, behavioral therapy and both treatments combined.

Many surgical interventions have been described for the treatment of stress urinary incontinence (SUI). This article focuses on the current understanding of the continence mechanism and new developments in the surgical management of SUI. Outcome data support restricting first-line interventions to retropubic urethropexy and the sling procedure. Literature on tension-free vaginal tape and the various graft materials described for use in the sling procedure are also reported.