Antibiotic utilization and symptom improvement in a retrospective cohort of women with urinary tract infection symptoms.

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.

Characteristics associated with composite surgical failure over 5 years of women in a randomized trial of sacrospinous hysteropexy with graft vs vaginal hysterectomy with uterosacral ligament suspension.

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/m2: 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.

Postoperative delirium in older patients after undergoing pelvic organ prolapse surgery.

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.

Characteristics associated with subjective and objective measures of treatment success in women undergoing percutaneous tibial nerve stimulation vs sham for accidental bowel leakage.

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.

Reoperation for prolapse recurrence after sacrospinous mesh hysteropexy: characteristics of women choosing retreatment.

INTRODUCTION AND HYPOTHESIS: Factors that contribute to reoperation and surgical approaches for the management of recurrent uterovaginal prolapse after vaginal mesh hysteropexy (mesh hysteropexy) are unknown. We aimed to describe surgical management of pelvic organ prolapse recurrence after vaginal mesh hysteropexy, and patient characteristics in those who chose reoperation. METHODS: This is a descriptive analysis of women who experienced treatment failure within 5 years of mesh hysteropexy in a multi-site randomized trial. The composite definition of treatment failure included retreatment (pessary or reoperation), prolapse beyond the hymen, or bothersome prolapse symptoms. Characteristics of those pursuing and not pursuing repeat prolapse surgery, measures of prolapse, and symptom severity are described. RESULTS: Over 5-year follow up, 31/91 (34%) of the hysteropexy group met treatment failure criteria. All seven women who pursued reoperation reported bothersome prolapse symptoms; six were anatomic failures. Most seeking reoperation were early treatment failures; six (86%) by the 12-month visit and all by the 18-month visit. Compared to those electing expectant management, those pursuing reoperation had more apical prolapse, POP-Q point C median (IQR) -5.5 (-6.0, -4.0) cm versus +1.0 (-1.0, 3.0) cm respectively. Hysterectomy was performed in 6/7 reoperations (three vaginal, three endoscopic), with apical suspension in 5/6 hysterectomies. One participant with posterior compartment prolapse underwent transvaginal enterocele plication, uterosacral ligament suspension with posterior colpoperineorrhaphy. At a mean surgical follow-up of 34.3 (15.8) months, all women remained without anatomic or symptomatic failure. CONCLUSIONS: When recurrent prolapse after mesh hysteropexy occurred, most women did not choose reoperation. Those who pursued surgery experienced more significant apical prolapse and were universally symptomatic. CLINICAL TRIAL IDENTIFICATION NUMBER: NCT01802281.

Percutaneous Tibial Nerve Stimulation vs Sham Stimulation for Fecal Incontinence in Women: NeurOmodulaTion for Accidental Bowel Leakage Randomized Clinical Trial.

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.

Effect of sacrospinous hysteropexy with graft vs vaginal hysterectomy with uterosacral ligament suspension on treatment failure in women with uterovaginal prolapse: 5-year results of a randomized clinical trial.

BACKGROUND: Vaginal hysterectomy with suture apical suspension is commonly performed for uterovaginal prolapse. Sacrospinous hysteropexy with graft (vaginal mesh hysteropexy) is an alternative, although in 2019 the Food and Drug Administration removed this mesh product from the United States market. OBJECTIVE: Our objective was to compare the efficacy and adverse events of these 2 procedures. STUDY DESIGN: At 9 clinical sites in the United States National Institutes of Health and National Institute of Child Health and Human Development Pelvic Floor Disorders Network, 183 postmenopausal women requesting vaginal surgery for symptomatic uterovaginal prolapse were enrolled in a multisite randomized superiority clinical trial, comparing a sacrospinous hysteropexy with graft (hysteropexy) with a vaginal hysterectomy with uterosacral ligament suspension (hysterectomy). Participants consented to remain masked to treatment assignment for the study duration. Study visits were conducted at 6-month intervals through 60 months. The primary treatment failure composite outcome (retreatment of prolapse, prolapse beyond the hymen, or prolapse symptoms) was evaluated with survival modeling. Secondary outcomes included complications or adverse events, individual anatomic measures of the pelvic organ prolapse quantification examination, and presence, severity, and impact and bother of prolapse, urinary, bowel, and pain symptoms as measured by validated questionnaires. The 3-year published results suggested better primary outcomes with sacrospinous hysteropexy with graft, but the differences were not statistically significant (P=.06). This study reports the 5-year outcomes. RESULTS: A total of 183 women with a mean age of 66 years were randomized between April 2013 and February 2015; 93 were randomized to hysteropexy and 90 were randomized to hysterectomy. Notably, 175 were included in the trial, and 156 (89%) completed the 5-year follow-up. The primary outcome showed fewer failures for hysteropexy than hysterectomy through 5 years (adjusted hazard ratio, 0.58; 95% confidence interval, 0.36-0.94; P=.03), with failure rates of 37% vs 54%, respectively, resulting in a difference of -18% (95% confidence interval, -33% to -3%) at 5 years. With the exception of the Urogenital Distress Inventory, no group differences were demonstrated in patient-reported pelvic floor symptoms, prolapse symptoms, bowel function symptoms, general quality of life, body image, or pelvic pain. At their last visit through 5 years, 70% of participants (129 of 183) reported they remained masked to their treatment with no difference in masking between groups. Adverse events for hysteropexy vs hysterectomy included mesh exposure (8% vs 0%), granulation tissue after 12 weeks (1% vs 12%), and suture exposure after 12 weeks (3% vs 21%), respectively. CONCLUSION: Among women with symptomatic uterovaginal prolapse undergoing vaginal surgery, sacrospinous hysteropexy with graft resulted in a lower composite failure rate than vaginal hysterectomy through 5 years. There were no meaningful differences in patient-reported outcomes between groups. Our results suggest that this vaginal mesh hysteropexy procedure should be made available to patients.

Subgroups of failure after surgery for pelvic organ prolapse and associations with quality of life outcomes: a longitudinal cluster analysis.

BACKGROUND: Treatment outcomes after pelvic organ prolapse surgery are often presented as dichotomous "success or failure" based on anatomic and symptom criteria. However, clinical experience suggests that some women with outcome "failures" are asymptomatic and perceive their surgery to be successful and that other women have anatomic resolution but continue to report symptoms. Characterizing failure types could be a useful step to clarify definitions of success, understand mechanisms of failure, and identify individuals who may benefit from specific therapies. OBJECTIVE: This study aimed to identify clusters of women with similar failure patterns over time and assess associations among clusters and the Pelvic Organ Prolapse Distress Inventory, Short-Form Six-Dimension health index, Patient Global Impression of Improvement, patient satisfaction item questionnaire, and quality-adjusted life-year. STUDY DESIGN: Outcomes were evaluated for up to 5 years in a cohort of participants (N=709) with stage ≥2 pelvic organ prolapse who underwent surgical pelvic organ prolapse repair and had sufficient follow-up in 1 of 4 multicenter surgical trials conducted by the Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Surgical success was defined as a composite measure requiring anatomic success (Pelvic Organ Prolapse Quantification system points Ba, Bp, and C of ≤0), subjective success (absence of bothersome vaginal bulge symptoms), and absence of retreatment for pelvic organ prolapse. Participants who experienced surgical failure and attended ≥4 visits from baseline to 60 months after surgery were longitudinally clustered, accounting for similar trajectories in Ba, Bp, and C and degree of vaginal bulge bother; moreover, missing data were imputed. Participants with surgical success were grouped into a separate cluster. RESULTS: Surgical failure was reported in 276 of 709 women (39%) included in the analysis. Failures clustered into the following 4 mutually exclusive subgroups: (1) asymptomatic intermittent anterior wall failures, (2) symptomatic intermittent anterior wall failures, (3) asymptomatic intermittent anterior and posterior wall failures, and (4) symptomatic all-compartment failures. Each cluster had different bulge symptoms, anatomy, and retreatment associations with quality of life outcomes. Asymptomatic intermittent anterior wall failures (n=150) were similar to surgical successes with Ba values that averaged around -1 cm but fluctuated between anatomic success (Ba≤0) and failure (Ba>0) over time. Symptomatic intermittent anterior wall failures (n=82) were anatomically similar to asymptomatic intermittent anterior failures, but women in this cluster persistently reported bothersome bulge symptoms and the lowest quality of life, Short-Form Six-Dimension health index scores, and perceived success. Women with asymptomatic intermittent anterior and posterior wall failures (n=28) had the most severe preoperative pelvic organ prolapse but the lowest symptomatic failure rate and retreatment rate. Participants with symptomatic all-compartment failures (n=16) had symptomatic and anatomic failure early after surgery and the highest retreatment of any cluster. CONCLUSION: In particular, the following 4 clusters of pelvic organ prolapse surgical failure were identified in participants up to 5 years after pelvic organ prolapse surgery: asymptomatic intermittent anterior wall failures, symptomatic intermittent anterior wall failures, asymptomatic intermittent anterior and posterior wall failures, and symptomatic all-compartment failures. These groups provide granularity about the nature of surgical failures after pelvic organ prolapse surgery. Future work is planned for predicting these distinct outcomes using patient characteristics that can be used for counseling women individually.

Incidence of postoperative cognitive dysfunction in older women undergoing pelvic organ prolapse surgery.

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.

30-Day unanticipated healthcare encounters after prolapse surgery: impact of same day discharge.

BACKGROUND: Same-day discharge is becoming increasingly common in gynecologic surgery; however, data are limited for frequency, setting, and severity of unanticipated healthcare visits for women who are discharged on the day of surgery after major prolapse repair. OBJECTIVE: The purpose of this study was to evaluate whether discharge on the day of surgery is associated with increased 30-day unanticipated healthcare encounters after major pelvic organ prolapse surgery compared with discharge on or after postoperative day 1. STUDY DESIGN: This is a retrospective analysis of women who underwent pelvic organ prolapse surgery by 8 female pelvic medicine and reconstructive surgery surgeons from January 2016 to October 2017. Unanticipated healthcare encounter was a composite variable of any visit to the office, emergency department, or hospital readmission. Number of visits, visit diagnoses, and complication severity (Clavien-Dindo classification) were compared by day of discharge with the use of χ2 tests. Multivariable analyses were performed. RESULTS: Of 405 women, 258 (63.7%) were discharged on the day of surgery, and 147 (36.3%) were discharged on postoperative day 1 or later. Mean age was 66±11 years, body mass index was 27.9±4.8 kg/m2. Most had stage III prolapse (n=273; 67.4%). Procedures included laparoscopic or robotic sacrocolpopexy, (n=163; 40.2%), vaginal apical suspensions (n=115; 28.4%), obliterative (n=105; 25.9%), and concomitant hysterectomy (n=229; 56.5%). There was no increase in the number of women with at least 1 unanticipated healthcare encounter within 30 days of surgery, based on discharge on the day of surgery compared with postoperative day 1 (24.0% vs 26.5%; P=.572). The majority of visits occurred in the office (17.8% vs 19.0%; P=.760). There was no increase in 30-day readmissions (3.5% vs 4.8%; P=.527). The most common visit diagnosis was pain and accounted for 31.5% of all visits, followed by urologic and gastrointestinal symptoms. Diagnoses and complication severity did not vary by day of discharge, except that women who were discharged on the day of surgery were more likely to have a superficial wound separation (11.3% vs 0%; P=.011) and less likely to experience grade II complications (7.4% vs 15.6%, P=.009). Few women had >1 unscheduled visit, and rates were similar between the 2 groups (6.2% vs 6.8%; P=.810). On multivariable regression, younger women (adjusted odds ratio, 1.03; 95% confidence interval, 1.001-1.05), those with lower body mass index (adjusted odds ratio, 1.07; 95% confidence interval, 1.13-1.01), and higher initial postanesthesia recovery unit pain scores (adjusted odds ratio, 1.11; 95% confidence interval, 1.02-1.21) were more likely to have an unanticipated healthcare encounter. Pain complaints were evaluated most often in the office compared with the emergency department (41.1% vs 13.0%); medical complications such as cardiac (15.6% vs 0%) and respiratory (6.5% vs 0%) were more likely to be evaluated in the emergency department. Higher grade complications (II/III) were more likely to visit the emergence department (78.2% vs 27.1%; P<.0001). CONCLUSION: Same-day discharge after prolapse surgery did not result in an increase in 30-day unanticipated healthcare encounters.

Association between adjuvant posterior repair and success of native tissue apical suspension.

BACKGROUND: Posterior repairs and perineorrhaphies are often performed in prolapse surgery to reduce the size of the genital hiatus. The benefit of an adjuvant posterior repair at the time of sacrospinous ligament fixation or uterosacral ligament suspension is unknown. OBJECTIVE: We aimed to determine whether an adjuvant posterior repair at transvaginal apical suspension is associated with improved surgical success. MATERIALS AND METHODS: This secondary analysis of Operations and Pelvic Muscle Training in the Management of Apical Support Loss (OPTIMAL) trial compared 24-month outcomes in 190 participants who had a posterior repair (posterior repair group) and 184 who did not (no posterior repair group) at the time of sacrospinous ligament fixation or uterosacral ligament suspension. Concomitant posterior repair was performed at the surgeon's discretion. Primary composite outcome of "surgical success" was defined as no prolapse beyond the hymen, point C ≤ -2/3 total vaginal length, no bothersome bulge symptoms, and no retreatment at 24 months. The individual components were secondary outcomes. Propensity score methods were used to build models that balanced posterior repair group and the no posterior repair group for ethnographic factors and preoperative Pelvic Organ Prolapse Quantification values. Adjusted odds ratios were calculated to predict surgical success based on the performance of a posterior repair. Groups were also compared with unadjusted χ2 analyses. An unadjusted probability curve was created for surgical success as predicted by preoperative genital hiatus. RESULTS: Women in the posterior repair group were less likely to be Hispanic or Latina, and were more likely to have had a prior hysterectomy and to be on estrogen therapy. The groups did not differ with respect to preoperative Pelvic Organ Prolapse Quantification stage; however, subjects in the posterior repair group had significantly greater preoperative posterior wall prolapse. There were no group differences in surgical success using propensity score methods (66.7% posterior repair vs 62.0% no posterior repair; adjusted odds ratio, 1.07; 95% confidence interval, 0.56-2.07; P = 0.83) or unadjusted test (66.2% posterior repair vs 61.7% no posterior repair; P = 0.47). Individual outcome measures of prolapse recurrence (bothersome bulge symptoms, prolapse beyond the hymen, or retreatment for prolapse) also did not differ by group. Similarly, there were no differences between groups in anatomic outcomes of any individual compartment (anterior, apical, or posterior) at 24 months. There was high variation in performance of posterior repair by surgeon (interquartile range, 15-79%). The unadjusted probability of overall success at 24 months, regardless of posterior repair, decreased with increasing genital hiatus, such that a genital hiatus of 4.5 cm was associated with 65.8% success (95% confidence interval, 60.1-71.1%). CONCLUSION: Concomitant posterior repair at sacrospinous ligament fixation or uterosacral ligament suspension was not associated with surgical success after adjusting for baseline covariates using propensity scores or unadjusted comparison. Posterior repair may not compensate for the pathophysiology that leads to enlarged preoperative genital hiatus, which remains prognostic of prolapse recurrence.

Defining the relationship between vaginal and urinary microbiomes.

BACKGROUND: Although the vaginal and urinary microbiomes have been increasingly well-characterized in health and disease, few have described the relationship between these neighboring environments. Elucidating this relationship has implications for understanding how manipulation of the vaginal microbiome may affect the urinary microbiome and treatment of common urinary conditions. OBJECTIVE: To describe the relationship between urinary and vaginal microbiomes using 16S rRNA gene sequencing. We hypothesized that the composition of the urinary and vaginal microbiomes would be significantly associated, with similarities in predominant taxa. STUDY DESIGN: This multicenter study collected vaginal swabs and catheterized urine samples from 186 women with mixed urinary incontinence enrolled in a parent study and 84 similarly aged controls. Investigators decided a priori that if vaginal and/or urinary microbiomes differed between continent and incontinent women, the groups would be analyzed separately; if similar, samples from continent and incontinent women would be pooled and analyzed together. A central laboratory sequenced variable regions 1-3 (v1-3) and characterized bacteria to the genus level. Operational taxonomic unit abundance was described for paired vaginal and urine samples. Pearson's correlation characterized the relationship between individual operational taxonomic units of paired samples. Canonical correlation analysis evaluated the association between clinical variables (including mixed urinary incontinence and control status) and vaginal and urinary operational taxonomic units, using the Canonical correlation analysis function in the Vegan package (R version 3.5). Linear discriminant analysis effect size was used to find taxa that discriminated between vaginal and urinary samples. RESULTS: Urinary and vaginal samples were collected from 212 women (mean age 53±11 years) and results from 197 paired samples were available for analysis. As operational taxonomic units in mixed urinary incontinence and control samples were related in canonical correlation analysis and since taxa did not discriminate between mixed urinary incontinence or controls in either vagina or urine, mixed urinary incontinence and control samples were pooled for further analysis. Canonical correlation analysis of vaginal and urinary samples indicated that that 60 of the 100 most abundant operational taxonomic units in the samples largely overlapped. Lactobacillus was the most abundant genus in both urine and vagina (contributing on average 53% to an individual's urine sample and 64% to an individual's vaginal sample) (Pearson correlation r=0.53). Although less abundant than Lactobacillus, other bacteria with high Pearson correlation coefficients also commonly found in vagina and urine included: Gardnerella (r=0.70), Prevotella (r=0.64), and Ureaplasma (r=0.50). Linear discriminant analysis effect size analysis identified Tepidimonas and Flavobacterium as bacteria that distinguished the urinary environment for both mixed urinary incontinence and controls as these bacteria were absent in the vagina (Tepidimonas effect size 2.38, P<.001, Flavobacterium effect size 2.15, P<.001). Although Lactobacillus was the most abundant bacteria in both urine and vagina, it was more abundant in the vagina (linear discriminant analysis effect size effect size 2.72, P<.001). CONCLUSION: Significant associations between vaginal and urinary microbiomes were demonstrated, with Lactobacillus being predominant in both urine and vagina. Abundance of other bacteria also correlated highly between the vagina and urine. This inter-relatedness has implications for studying manipulation of the urogenital microbiome in treating conditions such as urgency urinary incontinence and urinary tract infections.

Performance, acceptability, and validation of a phone application bowel diary.

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.

Bowel preparation prior to minimally invasive sacrocolpopexy: a randomized controlled trial.

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.

Effect of Vaginal Mesh Hysteropexy vs Vaginal Hysterectomy With Uterosacral Ligament Suspension on Treatment Failure in Women With Uterovaginal Prolapse: A Randomized Clinical Trial.

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.

Implementation of a urogynecology-specific enhanced recovery after surgery (ERAS) pathway.

OBJECTIVE: Enhanced recovery after surgery protocols were developed for colorectal surgery to hasten postoperative recovery. Variations of the protocol are being adopted for gynecological procedures despite limited population and procedure-specific outcome data. Our objective was to evaluate whether implementation of an enhanced recovery after surgery pathway would facilitate reduced length of admission in a urogynecology population. MATERIALS AND METHODS: In this retrospective analysis of patients undergoing pelvic floor reconstructive surgery by 7 female pelvic medicine and reconstructive surgeons, we compared same-day discharge, length of admission and postoperative complications before and after implementation of an enhanced recovery after surgery pathway at a tertiary care hospital. Groups were compared using χ2 and Student t tests. Candidate variables that could have an impact on patient outcomes with P < .2 were included in multivariable logistic regression models. Satisfaction with surgical experience was assessed using a phone-administered questionnaire the day after discharge. RESULTS: Mean age and body mass index of 258 women (137 before enhanced recovery after surgery and 121 enhanced recovery after surgery) were 65.5 ± 11.3 years and 28.2 ± 5.0 kg/m2. The most common diagnosis was pelvic organ prolapse (n = 242, 93.8%) including stage III pelvic organ prolapse (n = 61, 65.1%). Apical suspension procedures included 58 transvaginal (25.1%), 112 laparoscopic/robotic (48.8%), and 61 obliterative (26.4%). Hysterectomy was performed in 57.4% of women. Demographic and surgical procedures were similar in both groups. Compared with before enhanced recovery after surgery, the enhanced recovery after surgery group had a higher proportion of same-day discharge (25.9% vs 91.7%, P < .001) and a 13.8 hour shorter duration of stay (25.9 ± 13.5 vs 12.1 ± 11.2 hours, P <.001). Operative and postsurgical recovery room times were similar (2.6 ± 0.8 vs 2.6 ± 0.9 hours, P =.955; 3.7 ± 2.1 vs 3.6 ± 2.2 hours, P = .879). Women in the enhanced recovery after surgery group were more likely to be discharged using a urethral catheter (57.9% enhanced recovery after surgery vs 25.4% before enhanced recovery after surgery, P = .005). There were no group differences in total 30 day postoperative complications overall and for the following categories: urinary tract infections, emergency room visits, unanticipated office visits, and return to the operating room. However, enhanced recovery after surgery patients had higher 30 day hospital readmission rates (n = 8, 6.7% vs n = 2, 1.5%, P = .048). Patients before enhanced recovery after surgery were readmitted for myocardial infarction and chest pain. Enhanced recovery after surgery patients were admitted for weakness, chest pain, hyponatremia, wound complications, nausea/ileus, and ureteral obstruction. Three enhanced recovery after surgery patients returned to the operating room for ureteral obstruction (n = 1), incisional hernia (n = 1), and vaginal cuff bleeding (n = 1). Enhanced recovery after surgery patients also had more postoperative nursing phone notes (2.6 ± 1.7 vs 2.1 ± 1.4, P = .030). On multivariable logistic regressions adjusting for age and operative time, same-day discharge was more likely in the enhanced recovery after surgery group (odds ratio, 32.73, 95% confidence interval [15.23-70.12]), while the odds of postoperative complications and emergency room visits were no different. After adjusting for age, operative time, and type of prolapse surgery, readmission was more likely in the enhanced recovery after surgery group (odds ratio, 32.5, 95% confidence interval [1.1-28.1]). In the enhanced recovery after surgery group, patient satisfaction (n = 77 of 121) was reported as very good or excellent by 86.7% for pain control, 89.6% for surgery preparedness, and 93.5% for overall surgical experience; 89.6% did not recall any postoperative nausea during recovery. CONCLUSION: Enhanced recovery after surgery implementation in a urogynecology population resulted in a greater proportion of same-day discharge and high patient satisfaction but with slightly increased hospital readmissions within 30 days.

Early catheter removal after pelvic floor reconstructive surgery: a randomized trial.

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.

The urinary microbiome in women with mixed urinary incontinence compared to similarly aged controls.

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.

Methodology for a vaginal and urinary microbiome study in women with mixed urinary incontinence.

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.

OnabotulinumtoxinA vs Sacral Neuromodulation on Refractory Urgency Urinary Incontinence in Women: A Randomized Clinical Trial.

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.