A Comparison of U.S. Individual and Family Plan Medication Coverage for Overactive Bladder.

IMPORTANCE: There is strong evidence for long-term cognitive effects with anticholinergic use. Differences in insurance coverage of anticholinergics and beta-3 agonists hinder individualization of overactive bladder (OAB) treatment. OBJECTIVES: The aims of the study were to assess individual and family health insurance plan coverage for select OAB medications and to compare coverage of preferred medications to those with a greater risk of cognitive dysfunction. STUDY DESIGN: This cross-sectional study analyzed formularies for the top 7 U.S. medical insurers. Coverage tiers were assessed for the following 7 OAB medications: (1) oxybutynin instant-release 5 mg, (2) oxybutynin extended-release 5 mg, (3) solifenacin 5 mg, (4) trospium instant-release 20 mg, (5) trospium extended-release 60 mg, (6) mirabegron 25 mg, and (7) vibegron 75 mg. Coverage was compared between nonpreferred (oxybutynin, solifenacin) and preferred medications (trospium, mirabegron, vibegron). Coverage scores, representing a weighted average based on coverage tier frequency relative to the number of plans investigated for each state or insurer, were generated with a lower coverage score indicating better coverage (range, 0.2-1.0). RESULTS: A total of 2,780 insurance plans from 41 states representing a 47% market share for the individual and family marketplace were evaluated. Oxybutynin IR had the best coverage score across insurers (0.2) while vibegron had the worst (0.92). Preferred medications were more often designated to higher tiers with worse coverage compared with nonpreferred medications (P < 0.001). Less concordance in coverage between insurers was noted for anticholinergics with greater bladder specificity and for extended-release formulations. CONCLUSIONS: Despite risks with anticholinergics, beta-3 agonists were more expensive across all insurers highlighting the need for expanded coverage of preferred medications to avoid cognitive dysfunction when undergoing treatment for OAB.

Comparing Impact of Overactive Bladder Therapies on Nocturia.

IMPORTANCE: Nocturia is a significant symptom in overactive bladder with little data regarding the impact of overactive bladder treatments on nocturia. OBJECTIVES: Compare the effect of anticholinergic (AC) medication, onabotulinum toxin A (BTX), and sacral neuromodulation (SNM) on nocturia. STUDY DESIGN: Secondary analysis of the ABC and ROSETTA trials using data from the National Institutes of Health Data and Specimen Hub database. Patients reporting mean ≥2 voids/night on 3-day diary were included and divided into cohorts by treatment: the ABC trial: (1) AC and (2) BTX 100 units, and the ROSETTA trial: (3) BTX 200 units and (4) SNM. Primary outcome was change in mean voids/night on 3-day diary from baseline to 6 months assessed by mixed-effects models for repeated-measures data with interaction between treatment cohort and time included in model. RESULTS: A total of 197 patients were included: 43 (22%) AC, 37 (19%) BTX 100 U, 63 (32%) BTX 200 U, and 54 (27%) SNM. There were no significant differences in baseline voids/night, demographics, or urodynamic values except for younger age in AC and BTX 100 U cohorts (P = 0.04). At 6 months, all cohorts demonstrated a mean 41% decrease in mean voids/night (2.7 ± 0.4 at baseline to 1.6 ± 0.5 at 6 months; P < 0.001), with no significant difference in change in mean voids/night between treatment cohorts (decrease of 44% in AC, 46% in 100 U BTX, 32% 200 in U BTX, and 33% in SNM; P > 0.05). CONCLUSION: For women with nocturia ≥2/night, treatment with AC, BTX 100 or 200 units, or SNM led to a significant decrease in voids/night at 6 months.

A Retrospective Cohort Study of At-Home Catheter Removal After Urogynecologic Surgery.

IMPORTANCE: In-office postoperative voiding trials (VTs) increase health care burden for patients and physicians. Adoption of an at-home VT option may decrease burden without increasing adverse events postoperatively. OBJECTIVE: The purpose of this study was to compare 30-day postoperative outcomes between participants who performed an at-home autofill VT after catheter self-discontinuation during the Assessing Healthcare Utilization and Feasibility of Transurethral Catheter Self-discontinuation (FLOTUS) study and a "historic" control cohort of patients who presented to the office for backfill-assisted VT on postoperative day (POD) 1. STUDY DESIGN: This was a retrospective cohort study of women with postoperative urinary retention after urogynecologic surgery between June 2020 and March 2022. Outcomes from the FLOTUS study were compared with a "historic" control cohort of patients that were identified on chart review from the year before FLOTUS initiation. Demographic, medical history, and procedure-related data were collected. Thirty-day outcome data included office calls/messages, office visits, emergency department visits, complications, and catheterization outcomes. RESULTS: Forty-six participants were included in the FLOTUS cohort and 65 participants in the historic cohort. There was no difference in the POD1 VT pass rate, number of office calls/messages, emergency department visits, or postoperative complications between the 2 cohorts. The FLOTUS patients attended 1 less office visit (1 vs 2 office visits, P<0.001), and this difference persisted on regression analysis (-0.87 office visits; 95% CI, -1.18 to -0.56, P<0.001). CONCLUSION: Patients who had backfill-assisted VTs on POD1 attended 1 additional office visit compared with those who removed their catheters at home.

Repair of Vesicovaginal Fistulae: A Systematic Review.

OBJECTIVE: To assess and compile the current level of evidence regarding successful surgical treatment of vesicovaginal fistulae and how these perioperative interventions affect anatomic, patient-centered, and adverse outcomes. DATA SOURCES: PubMed and EMBASE were searched from inception through September 9, 2022. METHODS OF STUDY SELECTION: This review included comparative studies (of any sample size) and single-group studies (1,000 or more participants) of primary or recurrent vesicovaginal fistula (ie, vesicovaginal fistula, urethrovaginal fistula, and bladder neck-vaginal fistula). We evaluated preintervention assessment or management, various techniques for intraoperative management, and postoperative management. Outcomes of interest included anatomic and objective outcomes (such as successful repair, fistula closure, urinary incontinence, recurrent fistula, perioperative complications) and subjective outcomes (such as voiding symptoms and quality of life). Abstracts and full-text articles were screened in duplicate, and study descriptions and findings were extracted into standardized extraction forms. Risk of bias was assessed independently by two investigators and adjudicated by a third. Study quality was summarized with standardized tools. We conducted random-effects model and restricted maximum-likelihood meta-analyses of relative risks when at least three studies compared similar interventions and reported similar outcome measures. TABULATION, INTEGRATION, AND RESULTS: Forty-six studies met the inclusion criteria. Studies were categorized into 11 domains: 1) preoperative assessment, 2) preoperative and postoperative physical therapy, 3) route of surgery, 4) incorporation of a flap, 5) trimming, 6) layered closure, 7) intraoperative antibiotics, 8) fibrin glue, 9) fascial sling, 10) postoperative Foley catheter duration, and 11) quality of life. Although the strength of the data is insufficient, preoperative phenazopyridine, physical therapy, layered closure, and intraoperative antibiotics seemed to improve the rate of successful fistula repair. Route of surgery (vaginal vs abdominal laparotomy) was determined primarily by surgeon preference and showed no difference in successful fistula repair. In addition, use of interpositional flaps, trimming fistula edges, fibrin glue, and fascial sling did not show significant improvement in rates of fistula cure. Overall, quality-of-life scores improved postoperatively regardless of route of repair and use of interpositional flaps. CONCLUSION: Our findings highlight the limited information available to guide evidence-based treatment of vesicovaginal fistula repair. Overall, high-quality evidence is lacking to provide guidelines; therefore, expert opinion remains the primary influence for fistula repair recommendations. SYSTEMATIC REVIEW REGISTRATION: PROSPERO, CRD42021214948.

Current Clinical Practice Patterns in Total Vaginal Hysterectomy.

OBJECTIVES: There are no data on current surgical practice patterns for benign total vaginal hysterectomy (TVH) despite recently published guidelines. The objective was to determine gynecologic surgeon practice patterns regarding TVH perioperative interventions and to assess adherence to clinical practice guidelines. METHODS: A survey to assess TVH practice patterns was distributed to gynecologic surgical society members for completion. The primary outcome was to compare adherence to practice guidelines between fellowship-trained and non-fellowship-trained gynecologic surgeons. Secondary outcomes included comparing adherence based on age, practice location, and hysterectomy volume. RESULTS: Of the 204 respondents, there were 163 (80%) fellowship-trained and 41 (20%) non-fellowship-trained gynecologic surgeons. Fellowship-trained surgeons were more likely than non-fellowship-trained surgeons to use vaginal packing (34% vs 15%, P = 0.028), which is contrary to the recommendations. No cohort followed the guideline recommending a circular cervicovaginal incision. Fellowship-trained surgeons also were more likely than non-fellowship-trained surgeons to use the clamp and suture technique for vessel ligation (88% vs 68%, P = 0.004); otherwise, there were no significant differences between cohorts for adherence to any of the other guidelines. Although fellowship-trained surgeons were adherent to fewer of the guidelines as compared with surgeons without fellowship training, both groups generally adhered to a majority of the clinical practice guidelines for benign TVH. CONCLUSIONS: This information demonstrates a need for the development of targeted education and interventions to increase the use of evidence-based clinical practice guidelines during TVH for both fellowship-trained and non-fellowship-trained gynecologic surgeons.

The effect of 12-month postoperative weight change on outcomes following midurethral sling for stress urinary incontinence: a secondary analysis of the ESTEEM and TOMUS randomized trials.

INTRODUCTION AND HYPOTHESIS: Prior studies demonstrate mixed results on the impact of obesity on the success of midurethral slings (MUS), with little known about how postoperative weight change affects outcomes. We aimed to examine the effect of postoperative weight change on outcomes 12 months after MUS for stress urinary incontinence (SUI). METHODS: This secondary analysis utilized data from two multicenter randomized trials of women undergoing MUS placement. Subjects were categorized into cohorts based on change in body weight at 12 months postoperatively: weight gain (≥5% increase); weight loss (≥5% decrease), and weight stable (<5% change). The primary outcome was SUI cure (no SUI episodes in a 3-day bladder diary). Patients with mixed urinary incontinence (MUI) were analyzed for changes in daily average urge incontinence (UUI) episodes in a 3-day diary. Penalized logistic regression assessed the impact of demographic and perioperative variables on the primary outcome. RESULTS: Of the 918 women included, 635 (70%) were weight stable, 144 (15%) had weight gain, and 139 (15%) had weight loss. Patients in the weight loss cohort had a higher smoking rate and a higher baseline body mass index (SD 0.29, 2.7 respectively). All cohorts experienced high SUI cure rates ranging from 77 to 81%, with no significant difference in SUI cure between cohorts (p = 0.607). Of 372 subjects with MUI, the weight loss cohort had significantly greater improvement in UUI episodes. CONCLUSIONS: Weight change at 12 months postoperatively did not significantly alter efficacy of MUS for treatment of SUI. Patients with MUI who lost ≥5% body weight had significantly greater improvement in UUI episodes.

Nonestrogen Therapies for Treatment of Genitourinary Syndrome of Menopause: A Systematic Review.

OBJECTIVE: To systematically review the literature and provide clinical practice guidelines regarding various nonestrogen therapies for treatment of genitourinary syndrome of menopause (GSM). DATA SOURCES: MEDLINE, EMBASE, ClinicalTrials.gov , and Cochrane databases were searched from inception to July 2021. We included comparative and noncomparative studies. Interventions and comparators were limited to seven products that are commercially available and currently in use (vaginal dehydroepiandrosterone [DHEA], ospemifene, laser or energy-based therapies, polycarbophil-based vaginal moisturizer, Tibolone, vaginal hyaluronic acid, testosterone). Topical estrogen, placebo, other nonestrogen products, as well as no treatment were considered as comparators. METHODS OF STUDY SELECTION: We double-screened 9,131 abstracts and identified 136 studies that met our criteria. Studies were assessed for quality and strength of evidence by the systematic review group. TABULATION, INTEGRATION, AND RESULTS: Information regarding the participants, details on the intervention and comparator and outcomes were extracted from the eligible studies. Alternative therapies were similar or superior to estrogen or placebo with minimal increase in adverse events. Dose response was noted with vaginal DHEA and testosterone. Vaginal DHEA, ospemifene, erbium and fractional carbon dioxide (CO 2 ) laser, polycarbophil-based vaginal moisturizer, tibolone, hyaluronic acid, and testosterone all improved subjective and objective signs of atrophy. Vaginal DHEA, ospemifene, tibolone, fractional CO 2 laser, polycarbophil-based vaginal moisturizer, and testosterone improved sexual function. CONCLUSION: Most nonestrogen therapies are effective treatments for the various symptoms of GSM. There are insufficient data to compare nonestrogen options to each other.

Racial Disparities in Hysterectomy Route for Benign Disease: Examining Trends and Perioperative Complications from 2007 to 2018 Using the NSQIP Database.

STUDY OBJECTIVE: To examine national trends among race and ethnicity and route of benign hysterectomy from 2007 to 2018. DESIGN: This is a retrospective analysis of the prospective National Surgical Quality Improvement Program cohort program. SETTING: This study included data from the National Surgical Quality Improvement Program database including data from the 2014 to 2018 targeted hysterectomy files. PATIENTS: Adult patients undergoing hysterectomy. INTERVENTIONS: None MEASUREMENTS AND MAIN RESULTS: Current Procedural Terminology codes identified women undergoing benign hysterectomy and perioperative data including race and ethnicity were obtained. To determine relative trends in hysterectomy among race and ethnicity cohorts (White, Black, Hispanic), we calculated the proportion of each procedure performed annually within each race and ethnicity group and compared it across groups. From 2007 to 2018, 269 794 hysterectomies were collected (190 154 White, 45 756 Black, and 33 884 Hispanic). From 2007 to 2018, rates of laparoscopic hysterectomy increased in all cohorts (30.2%-71.6% for White, 23.9%-58.5% for Black, 19.9%-64.0% for Hispanic; ptrend <0.01 for all). For each year from 2007 to 2018, the proportion of women undergoing open abdominal hysterectomy remained twice as high in Black Women compared with White women (33.1%-14.4%, p <.01). Data from the 2014 to 2018 targeted files showed Black and Hispanic women undergoing benign hysterectomy were generally younger, had larger uteri, were more likely to be current smokers, have diabetes and/or hypertension, have higher body mass index, and have undergone previous pelvic surgery (p ≤.01 for all). CONCLUSION: Compared with White women, Black and Hispanic women are less likely to undergo benign hysterectomy via a minimally invasive approach. Although larger uteri and comorbid conditions may attribute to higher rates of open abdominal hysterectomy, the higher prevalence of abdominal hysterectomy among younger Black and Hispanic women highlights potential racial disparities in women's health and access to care.

Patient-Reported Outcome Measures for Use in Women With Pelvic Organ Prolapse: A Systematic Review.

OBJECTIVE: To describe the psychometric properties of existing patient-reported outcome measures for women with prolapse using the COSMIN (Consensus-Based Standards for the Selection of Health Measurement Instruments) framework. Additional objectives were to describe the patient-reported outcome scoring method or interpretation, methods of administration, and to compile a list of the non-English languages in which the patient-reported outcomes are reportedly validated. DATA SOURCES: PubMed and EMBASE was searched through September 2021. Study characteristics, patient-reported outcome details, and psychometric testing data were extracted. Methodologic quality was assessed with COSMIN guidelines. METHODS OF STUDY SELECTION: Studies reporting the validation of a patient-reported outcome in women with prolapse (or women with pelvic floor disorders that included a prolapse assessment) and reporting psychometric testing data on English-language patient-reported outcome for at least one measurement property per COSMIN and the U.S. Department of Health and Human Services definitions were included, as well as studies reporting the translation of an existing patient-reported outcome into another language, a new method of patient-reported outcome administration, or a scoring interpretation. Studies reporting only pretreatment and posttreatment scores, only content or face validity, or only findings for nonprolapse domains of the patient-reported outcome were excluded. TABULATION, INTEGRATION, AND RESULTS: Fifty-four studies covering 32 patient-reported outcomes were included; 106 studies assessing translation into a non-English language were excluded from the formal review. The number of validation studies per patient-reported outcome (one version of one questionnaire) ranged from 1 to 11. Reliability was the most reported measurement property, and most measurement properties received an average rating of sufficient. The condition-specific patient-reported outcomes had on average more studies and reported data across more measurement properties compared with adapted and generic patient-reported outcomes. CONCLUSION: Although measurement property data vary on patient-reported outcomes for women with prolapse, most data were of good quality. Overall, condition-specific patient-reported outcomes had more studies and reported data across more measurement properties. SYSTEMATIC REVIEW REGISTRATION: PROSPERO, CRD42021278796.

A prospective pilot study to assess for histologic changes on vulvar biopsies in postmenopausal women with lichen sclerosus treated with fractionated CO2 laser therapy.

OBJECTIVES: To investigate the histologic characteristics of vulvar tissues before and after completion of fractionated carbon dioxide (CO2 ) laser therapy (FxCO2) for vulvar lichen sclerosus (LS). The secondary objective was to assess subjective improvement in symptoms via the Skindex-16 questionnaire. METHODS: This prospective single-arm study was conducted from April 2021 to August 2022 at one academic medical center. Ten postmenopausal women with biopsy-proven LS planning FxCO2 laser treatment were enrolled. Exclusion criteria included prior transvaginal mesh for prolapse, topical corticosteroid use within 8 weeks, prior pelvic radiation, malignancy, active genital infection, or pregnancy. The vulvovaginal SmartXide2-V2-LR laser system fractionated CO2 laser (DEKA) was utilized to treat visually affected areas of vulvar and perianal LS with a single pass. Subjects underwent three treatments 4-6 weeks apart. Subjects completed the Skindex-16 questionnaire and had vulvar biopsy at baseline and at 4 weeks after completion of fractionated CO2 laser therapy. Blinded histologic slides were scored by one dermatopathologist (Michael A. Cardis) rating from 1 to 5 the degree of dermal sclerosis, inflammation, and epidermal atrophy. Change scores were calculated as the difference between pre- and post-treatment scores for each subject. RESULTS: The 10 subjects enrolled had a mean age of 61 and most were white, privately insured, and had a college/graduate-level education. Post-fractionated CO2 laser treatment vulvar biopsies showed significant improvement in sclerosis and epidermal atrophy compared with pretreatment baseline biopsy specimens (p < 0.05) with no statistically significant change found in inflammation score. Skindex-16 and FSFI scores showed a trend towards improvement (p > 0.05 for both). A statistically significant correlation was found between change in sclerosis and Skindex-16 symptoms scores with an average change of 21.4 units in Skindex-16 symptoms score for every one-point change in histologic sclerosis score (p = 0.03). CONCLUSIONS: In postmenopausal women with vulvar LS undergoing fractionated CO2 laser, symptomatic improvements correlated with histologic change in degree of sclerosis on vulvar biopsy. These results demonstrate FxCO2 laser therapy as a promising option for the treatment of LS and suggest that further studies should assess degree of sclerosis on histopathology.

Assessing Health Care Utilization and Feasibility of Transurethral Catheter Self-Discontinuation.

OBJECTIVE: To compare the rates of health care utilization (office messages or calls, office visits, and emergency department [ED] visits) and postoperative complications within 30 days after surgery between patients with successful voiding trials on postoperative day 0 and those with unsuccessful voiding trials on postoperative day 0 and between patients with successful and unsuccessful voiding trials on postoperative day 1. Secondary objectives were to identify risk factors for unsuccessful voiding trials on postoperative days 0 and 1 and to explore the feasibility of catheter self-discontinuation by assessing for any complications associated with at-home catheter self-discontinuation on postoperative day 1. METHODS: This study was a prospective observational cohort study of women undergoing outpatient urogynecologic or minimally invasive gynecologic surgery for benign indications at one academic practice from August 2021 to January 2022. Enrolled patients with unsuccessful immediate postoperative voiding trials on postoperative day 0 performed catheter self-discontinuation by cutting their catheter tubing per instructions at 6 am on postoperative day 1 and recording their voided volumes over the subsequent 6 hours. Patients who voided less than 150 mL underwent a repeat voiding trial in the office. Demographics, medical history, perioperative outcomes, and number of postoperative office calls or visits and ED visits within 30 days were collected. RESULTS: Of the 140 patients who met inclusion criteria, 50 patients (35.7%) had unsuccessful voiding trials on postoperative day 0, and 48 of these 50 (96%) performed catheter self-discontinuation on postoperative day 1. Two patients did not perform catheter self-discontinuation on postoperative day 1: One had her catheter removed in the ED on postoperative day 0 during an ED visit for pain control, and the other performed catheter self-discontinuation off protocol at home on postoperative day 0. There were no adverse events associated with at-home postoperative day 1 catheter self-discontinuation. Of the 48 patients who performed catheter self-discontinuation on postoperative day 1, 81.3% (95% CI 68.1-89.8%) had successful postoperative day 1 at-home voiding trials, and 94.5% (95% CI 83.1-98.6%) of those with successful voiding trials did not require additional catheterization. Patients with unsuccessful postoperative day 0 voiding trials had more office calls and messages (3 vs 2, P <.001) and those with unsuccessful postoperative day 1 voiding trials attended more office visits (2 vs 1, P <.001) compared with those with successful postoperative day 0 or 1 voiding trials, respectively. There was no difference in ED visits or postoperative complications between patients with successful voiding trials on postoperative day 0 or 1 and those with unsuccessful voiding trials on postoperative day 0 or 1. Patients with unsuccessful postoperative day 0 voiding trials were older and more likely to have undergone vaginal hysterectomy or prolapse repair than those with successful postoperative day 0 voiding trials. Patients with unsuccessful postoperative day 1 voiding trials were older than those with successful postoperative day 1 voiding trials. CONCLUSION: Catheter self-discontinuation is a feasible alternative to in-office voiding trials on postoperative day 1 after advanced benign gynecologic and urogynecologic surgery, with low rates of subsequent retention and no adverse events seen in our pilot study.

Longitudinal urinary microbiome characteristics in women with urgency urinary incontinence undergoing sacral neuromodulation.

INTRODUCTION AND HYPOTHESIS: The objective was to evaluate the stability of the urinary microbiome communities in women undergoing sacral neuromodulation (SNM) for urgency urinary incontinence (UUI). We hypothesized that clinical response to SNM therapy would be associated with changes in the urinary microbiome. METHODS: Women completed the Overactive Bladder Questionnaire Short-Form, the International Consultation on Incontinence Questionnaire Short Form, and the Female Sexual Function Index at baseline and 3 months post-SNM implantation. Transurethral urinary specimens were obtained for microbiome analysis at baseline and 3 months postoperatively. The V4 region of the 16S rRNA gene (515F-806R) was amplified with region-specific primers, and Amplicon Sequence Variants (ASVs) were identified with a closed-reference approach of taxonomic classification. Alpha-diversity was calculated using the phylogenetic (i.e., Faith's phylogenetic diversity) and nonphylogenetic metrics (i.e., Shannon diversity, and Pielou's evenness) using the QIIME2 plugin. Longitudinal paired volatility analysis was performed using the DEICODE and Gemelli plugin to account for host specificity across both time and space. RESULTS: Nineteen women who underwent SNM and provided both baseline and 3-month urine samples were included in this analysis. Women reported improvement in objective (number of UUI episodes) and subjective (symptom severity and health-related quality of life) measures. Ninety percent of the bacteria were classified as Bacteroidetes, Firmicutes, Proteobacteria, and Actinobacteria. No significant differences were observed in each subject's beta-diversity at 3 months compared with their baseline microbiome. CONCLUSIONS: Our descriptive pilot study of a cohort of women who had achieved objective and subjective improvements in UUI following SNM therapy demonstrates that the urinary microbiome remains relatively stable, despite variability amongst the cohort.

Characterization of the GU microbiome in women with self-perceived bladder health over the life course.

BACKGROUND: A variety of factors influence bladder health, including environmental factors, life experiences, biologic foundations, and coexistent medical conditions. A biologically diverse microbial community exists in the urine that is likely influenced by the microbial inhabitants of the vagina. The relationship between the genitourinary (GU) microbiome and self-perceived bladder health is unknown. OBJECTIVE: To longitudinally define the GU microbiome in women with self-percieved bladder health sampled across multiple time points over a year. STUDY DESIGN: Women with no reported lower urinary tract dysfunction or symptoms (LUTS) were recruited from six clinical sites and assessed every 6 weeks for 1 year. Voided urine and vaginal samples were longitudinally collected. Self-perceived bladder health was assessed with select items from the LURN comprehensive assessment of self-reported urinary symptoms (CASUS) tool. We defined four life phases as follows: young (18-34 years, nulliparous), midlife (35-45 years, menstruating), transitional (46-60 years, perimenopausal), mature (>60 years, not using vaginal and/or systemic hormone replacement therapy). DNA was extracted from samples, and the V4 region of the 16S rRNA gene was amplified with region-specific primers. The 16S rRNA sequencing on an Illumina NovaSeq. Microbial beta-diversity was calculated using DEICODE to identify microbial taxa that cluster in the samples. Longitudinal volatility analysis was performed using the gemelli plugin. Log-abundance ratios of microbial features were explored and visualized in Qurro. RESULTS: Fifty-four (N = 16 young, N = 16 midlife, N = 15 transitional, N = 7 mature) women were enrolled and provided baseline data. Most women in each life phase (93%-98%) continued to report self-perceived bladder health throughout the 1-year follow-up as assessed by CASUS items. Temporal-based microbial diversity of urinary and vaginal microbiome remained relatively stable over 1 year in all subjects. The GU microbiomes of mature women were distinct and microbially diverse from that of young, midlife, and transitional women, with genera of Gardnerella, Cupriavidus, and Dialister contributory to the microbial features of the mature microbiome. The mature GU microbiome was statistically different (p < 0.0001) from the midlife, transitional, and young microbiome for the log ratio of Gardnerella and Cupriavidus (in the numerator) and Lactobacillus (in the denominator) for voided samples and Gardnerella and Dialister (in the numerator) and Lactobacillus (in the denominator) for vaginal samples. Differences in the GU microbiome were also demonstrated via longitudinal beta-diversity between women developing urinary frequency as reported by CASUS responses or objectively on bladder diary compared to women without urinary frequency. CONCLUSION: In women with a self-perceived healthy bladder, the GU microbiome remained stable in all age groups over a 1 year period. Differences were seen with respect to life phase, where mature women were distinct from all other groups, and with respect to self-reported LUTS.

Examining Age and Postoperative Opioid Use in the Urogynecology Population: A Prospective Study.

IMPORTANCE: Surgeons must individualize postoperative pain management while also reducing the amount of unused prescribed opioids. OBJECTIVES: This study compared postoperative opioid use in younger versus older women following urogynecologic surgery. We also assessed the likelihood of women returning unused opioids for safe disposal. STUDY DESIGN: This was a prospective study of women undergoing pelvic reconstructive surgery divided into 2 cohorts: younger (<65 years) and older (≥65 years). Our primary outcome was total opioid use, measured in morphine milligram equivalents (MME). We also assessed the average pain score during the first week after surgery measured by a numerical pain scale (range, 0-10). Our secondary outcome was the rate of return of unused prescribed opioids at the 6-week postoperative visit utilizing a disposable drug deactivation system. RESULTS: From April 2019 to September 2021, 152 participants were enrolled: 92 (61%) in the younger cohort (mean age, 51 ± 8 years) and 60 (39%) in the older cohort (mean age, 72 ± 6 years). For our primary outcome, younger women used significantly more opioids during the first postoperative week compared with older women (49 ± 71 vs 28 ± 40 MME, respectively, P = 0.04), despite no difference in average pain scores (4 ± 2 younger vs 3 ± 2 older, P = 0.05). For our secondary outcome, 23% of participants returned their opioids for disposal with the drug deactivation system. CONCLUSIONS: Younger women had higher postoperative opioid use despite similar pain scores after urogynecologic surgery. Among those prescribed opioids, a quarter of participants returned their opioids for disposal at their postoperative visit.

Length of Stay and 30-Day Postoperative Complications Following Minimally Invasive Apical Prolapse Repair.

IMPORTANCE: Data on the correlation between length of stay and postoperative complications following urogynecologic surgery are limited. OBJECTIVES: The objective of this study was to use a nationwide database to examine the correlation between length of stay and 30-day postoperative complications following minimally invasive apical prolapse repair. STUDY DESIGN: This retrospective cohort study included women in the American College of Surgeons National Surgical Quality Improvement Program database from 2008 to 2018 who underwent laparoscopic/robotic sacrocolpopexy or uterosacral/sacrospinous repair and were discharged on postoperative day 0 (POD0) or 1 (POD1). The primary outcome was 30-day postoperative complication rate. RESULTS: Of the 28,269 women discharged home on POD0/1, 12,663 (45%) underwent laparoscopic/robotic sacrocolpopexy, and 15,606 (55%) underwent uterosacral/sacrospinous repair. Women discharged on POD0 were less likely to be White, less likely to have diabetes or hypertension, had lower mean body mass index, and were less likely to have undergone a hysterectomy ( P < 0.05 for all). Within 30 days of surgery, 7% had a postoperative complication, and 3% had a major complication. Women discharged on POD0 had a lower risk of any complication or any major complication. The most common complication, urinary tract infection, was lower in women discharged on POD0 (3% vs 4%, P < 0.01). Women discharged home on the same day had a higher risk of superficial surgical site infection after undergoing laparoscopic/robotic sacrocolpopexy (1.3% vs 0.5%, P < 0.01) and a higher risk of myocardial infarction/cardiac arrest after uterosacral/sacrospinous repair (0.2% vs 0%, P < 0.04). CONCLUSIONS: In women undergoing minimally invasive reconstructive apical repair, discharge on POD0 is correlated with similar or better (lower) 30-day postoperative complication rates compared with women discharged on POD1.

Randomized Clinical Trial of Gabapentin Versus Placebo for Pain After Sacrospinous Ligament Fixation.

OBJECTIVES: Given the risk of postoperative pain and specifically neuropathic gluteal pain after a sacrospinous ligament suspension, we conducted a randomized trial to compare a 2-week course of gabapentin versus placebo on postoperative pain after a sacrospinous ligament fixation. METHODS: This double-blinded, randomized, placebo-controlled trial compared 2 weeks of gabapentin (300 mg nightly for 3 days and then 300 mg twice a day for 11 days) versus identical-appearing placebo after a sacrospinous ligament fixation procedure. The primary outcome was participant-reported average pain during normal activity in the past 24 hours (score 0-10 on the validated Surgical Pain Scale) assessed on postoperative day (POD) 7. We also assessed average pain at rest and gluteal (buttocks) pain (score 0-10). We needed 17 participants per group to detect a 2.5-point difference in Surgical Pain Scale score with an SD of 2.6 (α = 0.05; power, 80%). RESULTS: The final intention-to-treat analysis compared 19 (49%) in the gabapentin group versus 20 (51%) in the placebo group. Between the gabapentin and placebo groups, average pain (2.0 ± 2.0 vs 3.4 ± 2.8, P = 0.09, respectively) and gluteal pain (2.1 ± 2.0 vs 3.4 ± 2.4, P = 0.09) during normal activity on POD 7 were not significantly different. However, average pain at rest on POD 7 was lower with gabapentin (1.6 ± 1.5 vs 3.2 ± 2.6, P = 0.04). CONCLUSIONS: Although a 2-week course of gabapentin did not significantly decrease overall pain with normal activity after a sacrospinous ligament fixation procedure, pain at rest was lower with gabapentin compared with placebo.

Disparities in Complications After Prolapse Repair and Sling Procedures: Trends From 2010-2018.

OBJECTIVE: To compare 30-day complication rates after prolapse repair and sling procedures across racial/ethnic groups, and evaluate trends over time. METHODS: We identified female patients in a national outcomes-based database who underwent prolapse repair and/or sling procedures between January 1, 2010 and December 31, 2018, stratified by race and ethnicity, and compared 30-day postoperative complication rates. Multivariable logistic regression adjusted for confounders. Trends in complication rates over time were evaluated using a test for trend (p-trend). RESULTS: We identified 70,540 prolapse repairs and 23,968 sling procedures. Following prolapse repairs, Black women had the highest complication rates (11%, vs 8% for Hispanic and 9% for both White and Other race/ethnicity women, P <0.01). Following sling procedures, there were few differences in complication rates between groups. After adjustments, Black women still experienced higher odds of any complication (aOR 1.15, 95% CI 1.03-1.29), particularly a vascular complication (venous thromboembolism or transfusion) (aOR 2.50, 95% CI 2.05-3.04) following prolapse repair procedures. Hispanic women had higher odds of vascular complications after prolapse repair (aOR 1.47, 95% CI 1.23-1.76) and slings (aOR 2.40, 95% CI 1.53-3.76). Trends from 2010-2018 showed a decrease in vascular complication rates among non-Black women after prolapse repairs, but rates among Black women did not decrease. CONCLUSION: Black women have higher odds of experiencing postoperative complications after prolapse repair procedures, particularly vascular complications. Vascular complication rates after prolapse repair decreased over time for all racial/ethnic groups except Black women. Hispanic women have higher odds of vascular complications after prolapse repair and slings than other racial/ethnic groups.

Cost-effectiveness of agents used for evaluation of ureteral patency during intraoperative cystoscopy in gynecologic and urogynecologic surgery.

BACKGROUND: Intraoperative evaluation of ureteral patency is often performed in gynecologic and urogynecologic surgery. Many agents are used to help assess the patency, each with its own associated cost, ease of use, and adverse reactions. Some agents, such as dextrose, are used as an instillation fluid to create a viscosity difference and aid the visualization of a ureteral jet. Others, such as oral phenazopyridine or the intravenous use of sodium fluorescein and indigo carmine, cause a color change of the urine to directly aid the visualization of ureteral jets. Recently, numerous studies have examined the efficacy and surgeon satisfaction of these agents. The studies have also emphasized certain options as associated with a lower cost. However, there have not been any cost studies comparing these agents. OBJECTIVE: To compare the cost-effectiveness of the following 4 agents that are commonly used in assessing ureteral patency intraoperatively: oral phenazopyridine, dextrose instillation, intravenous sodium fluorescein, and intravenous indigo carmine. STUDY DESIGN: We constructed a decision-analytic model to compare cystoscopy using oral phenazopyridine, dextrose instillation, intravenous sodium fluorescein, and intravenous indigo carmine. Failure to see efflux resulted in work-ups for ureteral obstruction. The probabilities were obtained from published studies, and the probability of successfully seeing efflux ranged from 0.92 with oral phenazopyridine to 0.99 with intravenous indigo carmine. The costs of the agents, adverse effects, and ureteral obstruction work-ups were obtained from the University of North Carolina at Chapel Hill Department of Pharmacy, the Healthcare Cost and Utilization Project 2016 database and the FAIR Health Consumer database. The cost of a ureteral obstruction work-up used in our model ranged from $9755 for intraoperative evaluation with retrograde pyelograms and stents to $29,034 for hospitalization. Our primary outcome was the incremental cost-effectiveness ratio per unnecessary work-up for ureteral obstruction avoided. Sensitivity analyses were performed to identify the key uncertainties. RESULTS: Oral phenazopyridine, followed by an intravenous agent if needed, had a mean cost of $110 per patient. Dextrose averaged $151 more per patient, with only a slight improvement in avoiding unnecessary ureteral obstruction work-ups and a higher cost associated with adverse reactions (incremental cost-effectiveness ratio, $62,000). Intravenous agents cost approximately $1000 more per patient and were less effective at preventing unnecessary work-ups. Sensitivity analyses did not identify any thresholds that would significantly change the outcomes. CONCLUSION: Our model suggests that oral phenazopyridine and dextrose instillation are the least expensive and the most effective agents to aid in the visualization of ureteral patency during intraoperative cystoscopy, although dextrose is associated with higher costs owing to a higher rate of adverse reactions (primarily urinary tract infections). Intravenous sodium fluorescein and indigo carmine are historically popular first-choice agents. However, they were found to be more expensive and less effective as primary agents in our model and should likely be reserved for use as secondary agents in the event that the visualization of ureteral jets is unclear with the initial use of phenazopyridine or dextrose.

A randomized trial comparing continence pessary to continence device (Poise Impressa®) for stress incontinence.

INTRODUCTION AND HYPOTHESIS: To conduct a multi-centered randomized trial evaluating stress urinary incontinence (SUI) treatment based on the Patient Global Impression of Improvement score after 4 weeks using a continence pessary (CP) or a disposable intravaginal continence device (DICD). The null hypothesis is no difference in treatment success between cohorts. METHODS: This parallel group, active treatment comparative effectiveness trial randomized women with SUI to either CP or DICD for 4 weeks in a 1:1 allocation ratio. Exclusion criteria included pregnancy, UTI, postmenopausal bleeding, neurogenic bladder, urinary retention, prolapse, contraindication to or prior treatment with CP/DICD, and prior SUI surgery. Assuming an 80% power, an alpha of 5% and 20% dropout, we needed 138 participants to detect 50% success with CP versus 25% with DICD. Due to slow enrollment, the study was stopped after 16 months with 50 participants enrolled. RESULTS: Of the 50 women enrolled, 25 (50%) were randomized to CP and 25 (50%) to DICD. Thirty-five of 50 (70%) completed a fitting, and 22/50 (44%) completed 4-week and 17/50 (34%) completed 6-month follow-up. Baseline characteristics were similar, and there was high treatment success in each cohort [80% (8/10) CP vs. 75% (9/12) DICD; p = 1.0]. DICD patients showed improvement on all questionnaires but had higher use of other therapies over 6 months. CP patients showed improvements except for lower sexual function scores at 4 weeks. No serious adverse events occurred. CONCLUSIONS: Most women fitted with a CP/DICD experienced treatment success after 4 weeks without serious adverse events.