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Objective: To investigate whether yoga and meditation added to usual care improves treatment response in women with interstitial cystitis-bladder pain syndrome., Methods: This randomized trial compared women with interstitial cystitis-bladder pain syndrome receiving standard care alone (control group) with those receiving standard care plus meditation and yoga (mind-body group). Standard care was defined as behavioral changes or medications recommended by the American Urological Association. Individuals in the control group received standard care, and those in the mind-body group received standard care augmented with a commercially available meditation application and standardized yoga tutorial video. Both groups continued their current interstitial cystitis-bladder pain syndrome standard care treatments. The primary outcome was the modified GRA (Global Response Assessment), comparing responders (moderately, markedly improved) with nonresponders at 12 weeks. On power analysis assuming α=5% and β=80%, a sample size of 82 participants was required to find 30% difference on the GRA between groups. Weekly GRA scores over 12 weeks were also compared. Secondary outcomes included ICPI (Interstitial Cystitis Problem Index)/ICSI (Interstitial Cystitis Symptom Index), pain, pain interference, anxiety/depression, and self-efficacy scores and treatment escalation over 12 weeks., Results: Among 97 randomized participants (49 mind-body group, 48 control group), groups did not differ in characteristics or symptoms at baseline. The mind-body group had more GRA responders compared with the control group at 12 weeks (31/43 [72.1%] vs 10/39 [25.6%], relative risk [RR] 2.8, 95% CI, 1.6-4.6), corroborated by superior weekly GRA results over 12 weeks. The mind-body group had superior beneficial change on the ICPI (RR 1.8, 95% CI, 0.5-3.1), ICSI (RR 1.9, 95% CI, 0.2-3.6), and pain (RR 1.4, 95% CI, 0.4-2.5) scores than the control group at 12 weeks. The mind-body group required less treatment escalation than the control group (2/45 [4.4%] vs 14/42 [33.3%], RR 0.13, 95% CI, 0.03-0.55)., Conclusion: The addition of meditation and yoga to standard interstitial cystitis-bladder pain syndrome care was associated with improved treatment response and required fewer additional interventions compared with standard care alone., Clinical Trial Registration: ClinicalTrials.gov, NCT04820855., Competing Interests: Financial Disclosure Angela N. Dao has been a consultation for Juniper Medical. Kate V. Meriwether: royalties from Elsevier publishing (book editing), royalties from UpToDate (peer review), consultation for Juniper Medical, editorial board position (honoraria or travel reimbursement) for journals of Obstetrics and Gynecology and Urogynecology, grant section for Centers for Disease Control (CDC) RFA-DP-24-031: Epidemiologic Cohort Study of Interstitial Cystitis. Her institution received a Caldera Medical 522 grant for which Dr. Meriwether is a site PI and for which she did not receive personal funds. The other authors did not report any potential conflicts of interest., (Copyright © 2024 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.)

Background: Urogynecologic literature confirms that pelvic floor disorders are detrimental to sexual function in heterosexual women and that sexual function improves following treatment. Few data exist regarding these issues in women who have sex with women, potentially affecting patient-provider interactions, treatment choices and outcomes., Objective: To describe sexual function concerns of women with pelvic floor disorders among women who have sex with women., Study Design: This was a multicenter qualitative study conducted to explore the sexual function of women who have sex with women and to investigate how pelvic floor dysfunction affected their sexual function. A semistructured interview guide was created to conduct one-on-one interviews via digital conferencing. The audio interviews were transcribed and deidentified. Transcripts were then analyzed with line-by-line coding by at least 2 independent researchers and organized into themes using a team-based approach. Interviews were conducted until thematic saturation was reached. Domains investigated included: knowledge and beliefs regarding pelvic floor disorders, impact of pelvic floor disorders on sexual function, and sexual function in general., Results: Eighteen women who have sex with women participated in cognitive interviews. Thematic saturation was reached. Participants' average age was 49.0 (±16.6) years, the majority self-identified as Non-Hispanic White, were healthy with minimal chronic medical conditions, and were married or living with a partner. Four major concepts emerged from the focus groups: (1) pelvic floor disorders resulted in fear and embarrassment and negatively affected sexual function, (2) women adapted their sexual lives to accommodate pelvic floor disorders, (3) partner choice & communication with that partner could ameliorate pelvic floor disorder effects on sexual function, and (4) women shared impressions potentially affecting future sexual function research and clinical care of women who have sex with women; a need for broader interpretation of sexual activity, the importance of nonjudgment and recognition of potential history of sexual trauma., Conclusion: A major theme reported by women with pelvic floor disorders who have sex with women mirrored those of heterosexual women; fear and embarrassment regarding their pelvic floor disorders and their effect on sexual function. These women also voiced novel viewpoints regarding sexual function and amelioration of pelvic floor disorder effects on sexual activity by partner choice and partner communication. Novel issues that could affect future sexual function research and clinical care of women who have sex with women include broadening the definition of sexual activity and emphasizing the importance of nonjudgmental and trauma-informed care., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: Urinary microbiome (urobiome) studies have previously reported on specific taxa and community differences in women with mixed urinary incontinence compared with controls. Therefore, a hypothesis was made that higher urinary and vaginal microbiome diversity would be associated with increased urinary incontinence severity., Objective: This study aimed to test whether specific urinary or vaginal microbiome community types are associated with urinary incontinence severity in a population of women with mixed urinary incontinence., Study Design: This planned secondary, cross-sectional analysis evaluated associations between the urinary and vaginal microbiomes and urinary incontinence severity in a subset of Effects of Surgical Treatment Enhanced With Exercise for Mixed Urinary Incontinence trial participants with urinary incontinence. Incontinence severity was measured using bladder diaries and Urinary Distress Inventory questionnaires collected at baseline. Catheterized urine samples and vaginal swabs were concurrently collected before treatment at baseline to assess the urinary and vaginal microbiomes. Of note, 16S rRNA V4 to V6 variable regions were sequenced, characterizing bacterial taxa to the genus level using the DADA2 pipeline and SILVA database. Using Dirichlet multinomial mixtures methods, samples were clustered into community types based on core taxa. Associations between community types and severity measures (Urinary Distress Inventory total scores, Urinary Distress Inventory subscale scores, and the number of urinary incontinence episodes [total, urgency, and stress] from the bladder diary) were evaluated using linear regression models adjusted for age and body mass index. In addition, alpha diversity measures for richness (total taxa numbers) and evenness (proportional distribution of taxa abundance) were analyzed for associations with urinary incontinence episodes and community type., Results: Overall, 6 urinary microbiome community types were identified, characterized by varying levels of common genera (Lactobacillus, Gardnerella, Prevotella, Tepidimonas, Acidovorax, Escherichia, and others). The analysis of urinary incontinence severity in 126 participants with mixed urinary incontinence identified a Lactobacillus-dominated reference group with the highest abundance of Lactobacillus (mean relative abundance of 76%). A community characterized by fewer Lactobacilli (mean relative abundance of 19%) and greater alpha diversity was associated with higher total urinary incontinence episodes (2.67 daily leaks; 95% confidence interval, 0.76-4.59; P=.007) and urgency urinary incontinence episodes (1.75 daily leaks; 95% confidence interval, 0.24-3.27; P=.02) than the reference group. No significant association was observed between community type and stress urinary incontinence episodes or Urogenital Distress Inventory total or subscores. The composition of vaginal community types and urinary community types were similar but composed of slightly different bacterial taxa. Vaginal community types were not associated with urinary incontinence severity, as measured by bladder diary or Urogenital Distress Inventory total and subscale scores. Alpha diversity indicated that greater sample richness was associated with more incontinence episodes (observed genera P=.01) in urine. Measures of evenness (Shannon and Pielou) were not associated with incontinence severity in the urinary or vaginal microbiomes., Conclusion: In the urobiome of women with mixed urinary incontinence, a community type with fewer Lactobacilli and more diverse bacteria was associated with more severe urinary incontinence episodes (total and urgency) compared with a community type with high predominance of a single genus, Lactobacillus. Whether mixed urinary incontinence severity is due to lesser predominance of Lactobacillus, greater presence of other non-Lactobacillus genera, or the complement of bacteria consisting of urobiome community types remains to be determined., (Copyright © 2023. Published by Elsevier Inc.)

Importance: Following standardized preoperative education and adoption of shared decision making positively affects postoperative narcotic practices., Objectives: The aim of this study was to assess the impact of patient-centered preoperative education and shared decision making on the quantities of postoperative narcotics prescribed and consumed after urogynecologic surgery., Study Design: Women undergoing urogynecologic surgery were randomized to "standard" (standard preoperative education, standard narcotic quantities at discharge) or "patient-centered" (patient-informed preoperative education, choice of narcotic quantities at discharge) groups. At discharge, the "standard" group received 30 (major surgery) or 12 (minor surgery) pills of 5-mg oxycodone. The "patient-centered" group chose 0 to 30 (major surgery) or 0 to 12 (minor surgery) pills. Outcomes included postoperative narcotics consumed and unused. Other outcomes included patient satisfaction/preparedness, return to activity, and pain interference. An intention-to-treat analysis was performed., Results: The study enrolled 174 women; 154 were randomized and completed the major outcomes of interest (78 in the standard group, 76 in the patient-centered group). Narcotic consumption did not differ between groups (standard group: median of 3.5 pills, interquartile range [IQR] of [0, 8.25]; patient centered: median of 2, IQR of [0, 9.75]; P = 0.627). The patient-centered group had fewer narcotics prescribed ( P < 0.001) and unused ( P < 0.001), and chose a median of 20 pills (IQR [10, 30]) after a major surgical procedure and 12 pills (IQR [6, 12]) after a minor surgical procedure, with fewer unused narcotics (median difference, 9 pills; 95% confidence interval, 5-13; P < 0.001). There were no differences between groups' return to function, pain interference, and preparedness or satisfaction ( P > 0.05)., Conclusions: Patient-centered education did not decrease narcotic consumption. Shared decision making did decrease prescribed and unused narcotics. Shared decision making in narcotic prescribing is feasible and may improve postoperative prescribing practices., Competing Interests: The authors have declared they have no conflicts of interest., (Copyright © 2023 American Urogynecologic Society. All rights reserved.)

Purpose: We determined the utility of intraoperative data in predicting sacral neuromodulation outcomes in urgency urinary incontinence., Materials and Methods: Intraoperative details of sacral neuromodulation stage 1 were recorded during the prospective, randomized, multicenter ROSETTA trial, including responsive electrodes, amplitudes, and response strengths (motor and sensory Likert scales). Stage 2 implant was performed for stage 1 success on 3-day diary with 24-month follow-up. An intraoperative amplitude response score for each electrode was calculated ranging from 0 (no response) to 99.5 (maximum response, 0.5 V). Predictors for stage 1 success and improvement at 24 months were identified by stepwise logistic regression confirmed with least absolute shrinkage and selection operator and stepwise linear regression., Results: Intraoperative data from 161 women showed 139 (86%) had stage 1 success, which was not associated with number of electrodes generating an intraoperative motor and/or sensory response, average amplitude at responsive electrodes, or minimum amplitude-producing responses. However, relative to other electrodes, a best amplitude response score for bellows at electrode 3 was associated with stage 1 failure, a lower reduction in daily urgency urinary incontinence episodes during stage 1, and most strongly predicted stage 1 outcome in logistic modeling. At 24 months, those who had electrode 3 intraoperative sensory response had lower mean reduction in daily urgency urinary incontinence episodes than those who had no response., Conclusions: Specific parameters routinely assessed intraoperatively during stage 1 sacral neuromodulation for urgency urinary incontinence show limited utility in predicting both acute and long-term outcomes. However, lead position as it relates to the trajectory of the sacral nerve root appears to be important.

Importance: Women with interstitial cystitis/bladder pain syndrome (ICBPS) face isolation and treatment challenges. Group medical visits using Centering models have successfully treated other conditions but have not been explored in ICBPS., Objective: This study aimed to describe ICBPS pain and symptom control comparing standard treatment alone versus standard treatment augmented with Centering visits., Study Design: This prospective cohort study recruited women with ICBPS receiving standard care (control) or standard care augmented with group Centering. We administered validated questionnaires at baseline and monthly for 12 months. The primary outcome was change in the pain numerical rating scale, with Patient-Reported Outcomes Measurement Information System Pain Interference Scale and Bladder Pain/Interstitial Cystitis Symptom Score change as secondary measures., Results: We enrolled 45 women (20 Centering, 25 controls). Centering had significantly better numerical rating scale pain scores at 1 month (mean difference [diff], -3.45) and 2 months (mean diff, -3.58), better Patient-Reported Outcomes Measurement Information System Pain Interference Scale scores at 1 month (mean diff, -10.62) and 2 months (mean diff, -9.63), and better Bladder Pain/Interstitial Cystitis Symptom Score scores at 2 months (mean diff, -13.19), and 3 months (mean diff, -12.3) compared with controls. In modeling, treatment group (Centering or control) and educational levels were both associated with all the outcomes of interest. Beyond 6 months, there were too few participants for meaningful analyses., Conclusions: Women with ICBPS participating in a Centering group have, in the short term, less pain, pain interference, and ICBPS-specific symptoms than patients with usual care alone. Larger studies with more follow-up are needed to determine if this treatment effect extends over time., (Copyright © 2022 American Urogynecologic Society. All rights reserved.)

Study Objective: Female patients with chronic pelvic pain (CPP) face complicated healthcare journeys, but narrative perspectives on CPP treatment are lacking., Design: We collected data in English and Spanish from discussion groups and individual interviews with stakeholders around female CPP., Setting: A tertiary care center for gynecologic care., Patients: Patients with CPP who self-identified as women/female, community healthcare workers, and providers who care for women with CPP., Interventions: We conducted discussion groups with all 3 types of stakeholders and individual interviews with female patients who have CPP., Measurements and Main Results: Patient participants completed condition specific validated questionnaires. De-identified transcripts were coded with NVivo software. We contrasted patient characteristics and codes between patients with CPP who did and did not report opioid use in the last 90 days. The mean pain score of patient participants was 6/10 ± 2/10, and 14 of 47 (28%) reported recent opioid use, without significant differences between patients with and without recent opioid use. Thematic saturation was achieved. Five main themes emerged: the debilitating nature of CPP, emotional impacts of CPP, challenges in CPP healthcare interactions, treatment for CPP, and the value of not feeling alone. Common threads voiced by stakeholders included difficulty discussing chronic pain with others, a sense of inertia in treatment, interest in alternative and less invasive treatments before more involved treatments, and the need for individualized, stepwise, integrated treatment plans. Participants agreed that opioids should be used when other treatments fail, but women recently using opioids voiced fewer concerns about addiction and positive experiences with opioid efficacy., Conclusions: These findings among female patients with CPP and also among community healthcare workers and providers advocate for a move toward patient-centered care, particularly the acknowledgment that every woman experiences pain in a singular way. Furthermore, stakeholders voice a deep need for development of individualized treatment plans., (Copyright © 2022 AAGL. Published by Elsevier Inc. All rights reserved.)

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

Importance: Women with interstitial cystitis/bladder pain syndrome (ICBPS) face challenging treatment and feelings of isolation. Centering models of group medical visits have been successful in other spheres but have not been explored in ICBPS therapy., Objective: We sought to describe opinions of women with ICBPS regarding Centering visits, including advantages, experience, and barriers to participation and efficacy., Study Design: Patients who attended Centering visits participated in a focus group and/or filled out written commentary in evaluations, and control patients were individually interviewed. We coded transcripts using NVivo software for emergent themes., Results: We conducted 4 control patient individual interviews, had one focus group of Centering patients, and collected comments from 34 post-Centering surveys. Emergent themes of interest included motivations and barriers to joining, cost, leadership, connecting with others, diversity, learning, alternative treatments, and areas for improvement. Regardless of participation in Centering, patients noted the importance of self-care and sharing with other women with ICBPS, and they emphasized feelings of isolation in their disease and discouraging health care experiences. Women in Centering noted that the biggest advantages of Centering were learning from other women with ICBPS, the creation of a welcoming and safe space, and the feeling that Centering was more of a support group than a medical visit. Women noted that barriers to Centering included cost and logistical issues, such as time and format., Conclusions: Women with ICBPS treatment note that Centering group visits provide a sense of learning and community that opens them to a wider variety of options., Competing Interests: K.M. is a consultant for RBI Medical, serves on the Executive Board of the Society of Gynecologic Surgeons, receives royalties from Elsevier Publishing, and is an unpaid researcher for Cook MyoSure and Caldera. The remaining authors have declared they have no conflicts of interest., (Copyright © 2022 American Urogynecologic Society. All rights reserved.)

Background: Although povidone-iodine (iodine) is the only Food and Drug Administration-approved vaginal antiseptic solution, there is a lack of comparative data evaluating alternatives. Chlorhexidine gluconate is readily accessible, recommended by multiple societies as an alternative for patients with iodine allergy, and preliminary data indicate that it may provide superior antisepsis., Objective: This study aimed to compare the effectiveness of chlorhexidine and iodine as presurgical vaginal antiseptic solutions in preventing the most common surgery-associated infection after gynecologic surgery, urinary tract infections., Study Design: We conducted a randomized controlled noninferiority trial among women undergoing urogynecologic surgery. The primary outcome measure was symptomatic urinary tract infection within 2 weeks after surgery. The secondary outcomes included culture-proven urinary tract infection at 2 and 6 weeks after surgery, symptomatic urinary tract infections at 6 weeks after surgery, any surgical site infection at 2 weeks after surgery, and patient-reported vaginal irritation after surgery. We required 58 participants per arm to demonstrate noninferiority of chlorhexidine vs iodine (margin of relative risk of <1.5 for the upper limit of 95% confidence interval) between groups for the primary outcome., Results: A total of 119 participants (61 in the chlorhexidine group and 58 in the iodine group) completed the primary outcome and were included in the analyses. There was no difference in the groups' demographic characteristics, medical history, operations performed, or perioperative factors. Chlorhexidine was not inferior to iodine concerning the primary outcome, symptomatic urinary tract infection at 2 weeks after surgery (10% vs 17%; relative risk, 0.6; 95% confidence interval [-∞, 1.3]). Furthermore, chlorhexidine was not inferior to iodine for the secondary urinary tract infection outcomes (culture-proven urinary tract infection at 2 and 6 weeks after surgery and symptomatic urinary tract infection at 6 weeks after surgery). Groups were similar in terms of surgical site infection (overall 3/119 [2.5%]) and presence of any vaginal irritation (4/54 [7.4%], for both groups)., Conclusion: Chlorhexidine was not inferior to iodine for vaginal antisepsis before urogynecologic surgery concerning urinary tract infection. Given the similar postoperative urinary tract infection rates demonstrated in this study and the lack of difference in vaginal irritation, chlorhexidine seemed to be a safe and reasonable option for vaginal antisepsis before surgical procedures. Additional studies are needed to further examine surgical site infection., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Objectives: To (1) evaluate attitudes of resident physicians towards patients with opioid use disorder (OUD) and (2) identify characteristics associated with residents' desire to treat patients with OUD., Methods: We administered the validated medical condition regard scale (MCRS), a question regarding desire to treat patients with OUD, and a demographic questionnaire to residents in multiple specialties at the University of New Mexico (family medicine, psychiatry, emergency medicine, internal medicine, anesthesiology, general surgery, obstetrics/gynecology)., Results: One hundred sixty-three of 307 residents (53%) responded to the survey; 146 provided complete responses to the "desire" and MCRS questions. Response rates, MCRS, and desire to care for patients with OUD varied between specialties ( P < 0.001); family medicine had highest MCRS and desire to care scores; surgery, anesthesiology had low scores. MCRS and resident "desire" scores were highly correlated on univariate analysis ( r = 0.73, P < 0.001); resident demographics were not. On logistic regression, resident desire to care for OUD increased with MCRS scores ( P < 0.001). The predicated probability of desire to care for OUD was ≥80% with MCRS >57; MCRS classification skill on receiver operator curve analysis was excellent (area under curve = 0.81 [95% confidence interval 0.74, 0.88], and specialty-adjusted MCRS area under curve = 0.85 [95% confidence interval 0.79, 0.91])., Conclusions: High resident regard for patients with OUD on MCRS was directly related to resident's desire to provide OUD care. MCRS may offer a tool to alter or individualize OUD education, potentially influencing the OUD workforce of the future., Competing Interests: The authors report no conflicts of interest., (Copyright © 2022 American Society of Addiction Medicine.)

Objectives: The objectives of this study are (1) to estimate the incidence of midurethral sling revision/removal in women with preexisting pain diagnoses versus those without these diagnoses and (2) to describe associations between numbers and type of pain diagnoses with revision/removal., Methods: Women who underwent midurethral sling surgery between 2009 through 2014 were identified in the MarketScan database and tracked and December 31, 2014. Patients with preoperative chronic pain diagnoses (fibromyalgia, endometriosis, irritable bowel, dyspareunia, low back pain, temporomandibular joint syndrome, interstitial cystitis, pelvic/perineal pain) were compared with controls (those without these diagnoses) regarding mesh sling revision/removal. Logistic regression identified variables associated with mesh revision/removal, and survival analysis compared timing of mesh removal/revision., Results: There were 161,459 women who underwent midurethral sling surgery (pain, 83,484; nonpain, 77,975). Pain and nonpain groups differed in age (52.1 vs 53.5 years, P < 0.01) and insurance status (P < 0.01), with the pain group more commonly living in the South or West. Mean follow-up was 42.3 months. Cumulative risk for sling revision/removal was higher in patients with 1 pain diagnosis relative to controls (relative risk, 1.54; 95% confidence interval [CI], 1.41-1.54). Risks increased with increased pain diagnoses (≥4 diagnoses; relative risk, 3.13; 95% CI, 2.81-3.47). Pelvic pain conditions had greatest odds of mesh revision/removal (dyspareunia adjusted odds ratio [aOR], 2.44; 95% CI, 2.23-2.63; interstitial cystitis aOR, 1.46; 95% CI, 1.27-1.66; pelvic/perineal pain aOR, 1.41; 95% CI, 1.33-1.48). Co-occurrence of dyspareunia and interstitial cystitis or pelvic/perineal pain had 12.7% cumulative incidence of sling revision/removal. Cox proportional hazards revealed greatest risk for those with pelvic pain conditions (hazard ratio, 2.40; 95% CI, 2.13-2.70)., Conclusions: Chronic pain diagnoses increased risk of midurethral sling revision/removal; pelvic pain and numbers of diagnoses increased this risk., Competing Interests: P.C.J. is a consultant for Ethicon. G.D. received a research support from Pelvalon and Viveve. K.M. received book royalties from Elsevier Publishing, travel stipend for position as Research Chair of Society of Gynecologic Surgeons (voting Board position), consultant for RBI Medical. C.N. received research support from Cook Myosite. The remaining authors have declared they have no conflicts of interest., (Copyright © 2022 American Urogynecologic Society. All rights reserved.)

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

Background: The urogenital microbiome is associated with urgency and mixed urinary incontinence symptoms and differential treatment responses to pharmacotherapy for urgency urinary incontinence., Objective: This study aimed to describe whether the preoperative urinary and vaginal microbiomes were associated with surgical treatment responses at 12 months after a midurethral sling operation in women with mixed urinary incontinence., Study Design: This cohort study compared the preoperative microbiome compositions of urine and vaginal samples from a subset of women undergoing a midurethral sling operation in the Effects of Surgical Treatment Enhanced With Exercise for Mixed Urinary Incontinence trial (NCT01959347) and compared the microbiota in women who were surgical responders vs surgical nonresponders. Twelve-month objective response was defined as a ≥70% reduction from baseline urinary incontinence episodes on a 3-day diary. Subjective response was defined as a change from baseline in the Urogenital Distress Inventory scores. Bacterial abundance and beta diversity were assessed using 16S ribosomal RNA sequencing. The primary differential abundance analysis described predominant bacterial operational taxonomic units associated with responders vs nonresponders using unadjusted and age-adjusted linear models., Results: Objective nonresponders (n=28) compared with responders (n=72) were older (58.5±10.7 vs 51.6±10.2 years) and more likely postmenopausal without hormone use (odds ratio, 6.4; 95% confidence interval, 1.8-22.6). Vaginal and urinary microbiota beta diversities were associated with age (P<.05) for both responders and nonresponders. Overall, predominant operational taxonomic units (genera) were Lactobacillus, Gardnerella, Tepidimonas, Escherichia, Streptococcus, and Prevotella. Operational taxonomic units from baseline urine samples were not significantly associated (P threshold=.05) with surgical treatment responses. A greater abundance of baseline vaginal Lactobacillus was associated with an objective response (P=.04) and Prevotella with an objective nonresponse (P=.01). Adjusting for age, only a greater abundance of baseline vaginal Prevotella was associated with an objective nonresponse (P=.01). Moreover, less abundant vaginal operational taxonomic units were associated with objective and subjective responses and persistent urinary incontinence symptoms (P<.05)., Conclusion: Women meeting a 70% reduction of urinary incontinence treatment episodes (objective responders) had greater vaginal Lactobacillus at the time of the surgical procedure; however, controlling for age diminished this association. Women not meeting a 70% reduction of urinary incontinence episodes 1 year after a midurethral sling operation had greater vaginal Prevotella at the time of the midurethral sling operation. Further research is needed to determine whether therapy altering the vaginal microbiome may impact surgical treatment responses in women with mixed urinary incontinence., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background: Prolapse recurrence after transvaginal surgical repair is common; however, its mechanisms are ill-defined. A thorough understanding of how and why prolapse repairs fail is needed to address their high rate of anatomic recurrence and to develop novel therapies to overcome defined deficiencies., Objective: This study aimed to identify mechanisms and contributors of anatomic recurrence after vaginal hysterectomy with uterosacral ligament suspension (native tissue repair) vs transvaginal mesh (VM) hysteropexy surgery for uterovaginal prolapse., Study Design: This multicenter study was conducted in a subset of participants in a randomized clinical trial by the Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Overall, 94 women with uterovaginal prolapse treated via native tissue repair (n=48) or VM hysteropexy (n=46) underwent pelvic magnetic resonance imaging at rest, maximal strain, and poststrain rest (recovery) 30 to 42 months after surgery. Participants who desired reoperation before 30 to 42 months were imaged earlier to assess the impact of the index surgery. Using a novel 3-dimensional pelvic coordinate system, coregistered midsagittal images were obtained to assess study outcomes. Magnetic resonance imaging-based anatomic recurrence (failure) was defined as prolapse beyond the hymen. The primary outcome was the mechanism of failure (apical descent vs anterior vaginal wall elongation), including the frequency and site of failure. Secondary outcomes included displacement of the vaginal apex and perineal body and change in the length of the anterior wall, posterior wall, vaginal perimeter, and introitus of the vagina from rest to strain and rest to recovery. Group differences in the mechanism, frequency, and site of failure were assessed using the Fisher exact tests, and secondary outcomes were compared using Wilcoxon rank-sum tests., Results: Of the 88 participants analyzed, 37 (42%) had recurrent prolapse (VM hysteropexy, 13 of 45 [29%]; native tissue repair, 24 of 43 [56%]). The most common site of failure was the anterior compartment (VM hysteropexy, 38%; native tissue repair, 92%). The primary mechanism of recurrence was apical descent (VM hysteropexy, 85%; native tissue repair, 67%). From rest to strain, failures (vs successes) had greater inferior displacement of the vaginal apex (difference, -12 mm; 95% confidence interval, -19 to -6) and perineal body (difference, -7 mm; 95% confidence interval, -11 to -4) and elongation of the anterior vaginal wall (difference, 12 mm; 95% confidence interval, 8-16) and vaginal introitus (difference, 11 mm; 95% confidence interval, 7-15)., Conclusion: The primary mechanism of prolapse recurrence following vaginal hysterectomy with uterosacral ligament suspension or VM hysteropexy was apical descent. In addition, greater inferior descent of the vaginal apex and perineal body, lengthening of the anterior vaginal wall, and increased size of the vaginal introitus with strain were associated with anatomic failure. Further studies are needed to provide additional insight into the mechanism by which these factors contribute to anatomic failure., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Objectives: The aim of this study is to identify and describe the information that is important to patients in preparation for surgery for pelvic floor disorders., Methods: This qualitative study enrolled English- and Spanish-speaking patients who had undergone surgery for pelvic floor disorders in semistructured focus groups. We explored patients' attitudes and views regarding preoperative education, postoperative experiences, and quality of pain management. Focus groups were conducted until thematic saturation was reached. Deidentified focus group transcripts were analyzed with line-by-line coding and organized into themes using a team-based process., Results: Four focus groups were conducted, 2 with English-speaking women (n = 14) and 2 with Spanish-speaking women (n = 10). Participants identified as non-Hispanic White 13/24 (54%) or Hispanic 11/24 (46%); 83% had at least a high school education and 50% had a bachelor's degree. Women reported 5 thematic domains of information that they deemed important for patients to know preoperatively: (1) preparation for surgery; (2) postoperative pain control expectations; (3) postoperative activity restrictions; (4) communication with care team; and (5) care experiences., Conclusions: This study identifies information that is important to patients undergoing pelvic floor surgery. These patient-centered themes go beyond routine preoperative education and counseling. This information will aid future studies regarding the incorporation of patient-centered preoperative education and expectation setting with respect to improved pain control, patient satisfaction, and overall surgical experience., Competing Interests: The authors have declared they have no conflicts of interest., (Copyright © 2021 American Urogynecologic Society. All rights reserved.)

Objective: The aim of the study was to assess whether home biofeedback is noninferior to supervised pelvic floor physical therapy (PFPT) for the treatment of stress urinary incontinence (SUI) in women., Methods: The study used a randomized controlled noninferiority trial to compare a home biofeedback device with PFPT. Women older than 18 years with SUI and no history of a prior incontinence surgery or PFPT were eligible. Forty-two participants were required to determine noninferiority for the primary outcome, improvement in quality of life as measured by the International Consultation on Incontinence Questionnaire Short Form. The noninferiority margin was 4 points. Secondary outcomes included sexual function, overactive bladder symptoms, and patient impression of improvement., Results: From June 2018 to October 2019, 54 women with SUI were recruited (27 biofeedback, 27 PFPT) and 43 (21 biofeedback, 22 PFPT) completed follow-up. The groups had comparable baseline characteristics. For the primary outcome of change in mean International Consultation on Incontinence Questionnaire-Short Form scores (where lower scores indicate less incontinence), home biofeedback was found to be noninferior to PFPT with a mean decrease from baseline of -3.95 (95% confidence interval [CI] = -2.21 to -5.70) in the home biofeedback group versus -4.73 (95% CI = -3.21 to -6.25) and -3.95 (95% CI = -2.21 to -5.70) in the PFPT group (P = 0.009). The PFPT group showed more improvement in overactive bladder symptoms, but not in incontinence severity without difference in sexual function., Conclusions: Home biofeedback was noninferior to PFPT for the primary treatment of SUI in women at 3 months. These results support the use of personal biofeedback devices for the treatment of SUI.Clinical Trial Registration: ClinicalTrials.gov, http://www.clinicaltrials.gov, NCT03443687., Competing Interests: The authors have declared they have no conflicts of interest., (Copyright © 2020 American Urogynecologic Society. All rights reserved.)

Background: Prior study of patients with urgency urinary incontinence by functional magnetic resonance imaging showed altered function in areas of the brain associated with interoception and salience and with attention. Our randomized controlled trial of hypnotherapy for urgency urinary incontinence demonstrated marked improvement in urgency urinary incontinence symptoms at 2 months. A subsample of these women with urgency urinary incontinence underwent functional magnetic resonance imaging before and after treatment., Objective: This study aimed to determine if hypnotherapy treatment of urgency urinary incontinence compared with pharmacotherapy was associated with altered brain activation or resting connectivity on functional magnetic resonance imaging., Study Design: A subsample of women participating in a randomized controlled trial comparing hypnotherapy vs pharmacotherapy for treatment of urgency urinary incontinence was evaluated with functional magnetic resonance imaging. Scans were obtained pretreatment and 8 to 12 weeks after treatment initiation. Brain activation during bladder filling and resting functional connectivity with an empty and partially filled bladder were assessed. Brain regions of interest were derived from those previously showing differences between healthy controls and participants with untreated urgency urinary incontinence in our prior work and included regions in the interoceptive and salience, ventral attentional, and dorsal attentional networks., Results: After treatment, participants in both groups demonstrated marked improvement in incontinence episodes (P<.001). Bladder-filling task functional magnetic resonance imaging data from the combined groups (n=64, 30 hypnotherapy, 34 pharmacotherapy) demonstrated decreased activation of the left temporoparietal junction, a component of the ventral attentional network (P<.01) compared with baseline. Resting functional connectivity differed only with the bladder partially filled (n=54). Compared with pharmacotherapy, hypnotherapy participants manifested increased functional connectivity between the anterior cingulate cortex and the left dorsolateral prefrontal cortex, a component of the dorsal attentional network (P<.001)., Conclusion: Successful treatment of urgency urinary incontinence with both pharmacotherapy and hypnotherapy was associated with decreased activation of the ventral (bottom-up) attentional network during bladder filling. This may be attributable to decreased afferent stimuli arising from the bladder in the pharmacotherapy group. In contrast, decreased ventral attentional network activation associated with hypnotherapy may be mediated by the counterbalancing effects of the dorsal (top-down) attentional network., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to determine if a perineorrhaphy at the time of apical pelvic organ prolapse surgery positively affects women's body image., Methods: This is a randomized controlled trial of women undergoing apical suspension procedures in which women (GH ≥2 cm to ≤6 cm) received either perineorrhaphy or no perineorrhaphy. The primary aim compared body image between the groups postoperatively using the Body Image in Pelvic Organ Prolapse (BIPOP) questionnaire. Secondary outcomes included prolapse stage, pain, pelvic floor muscle strength, pelvic floor symptoms, and sexual function. Between- and within-group differences were compared using Fisher exact test for categorical variables and t tests for continuous variables. When continuous variables were not normally distributed, the Welch-Satterthwaite test was used. Within-group analyses were performed via paired t tests for select continuous variables., Results: Forty-six women were enrolled; 45 (97.8%) completed the 6-week assessment and 38 (82.6%) completed the 3-month assessment. There were no differences in baseline characteristics. Although women within groups had an expected improvement in mean Body Image in Pelvic Organ Prolapse and subscale scores between baseline and 3 months (P < 0.05), there were no differences in the mean scores between groups. In addition, there were no differences between groups in any of the secondary outcomes., Conclusions: Performance of apical prolapse surgery improved women's body image, irrespective of performance of a perineorrhaphy. Other important outcomes, including pain, did not differ between women in the 2 groups. These findings demonstrate the need for further trials to investigate the utility of this procedure., Competing Interests: C.S.N. is affiliated with Cook MyoSite. Y.M.K. received research support from the National Institutes of Health, National Institute of Child Health and Human Development (Pelvic Floor Disorders Network), National Center for Complementary and Integrative Health, and Cook MyoSite. R.G.R. received UptoDate royalties, travel, lodging, and stipends from IUGA, ABOG, and ACOG. G.C.D. received research support from Pelvalon, Viveve, and the Pelvic Floor Disorders Network, and received travel and lodging from ABOG and ACOG. The other authors declare no conflicts of interest to declare., (Copyright © 2020 American Urogynecologic Society. All rights reserved.)

Introduction and Hypothesis: The protocol and analysis methods for the Defining Mechanisms of Anterior Vaginal Wall Descent (DEMAND) study are presented. DEMAND was designed to identify mechanisms and contributors of prolapse recurrence after two transvaginal apical suspension procedures for uterovaginal prolapse., Methods: DEMAND is a supplementary cohort study of a clinical trial in which women with uterovaginal prolapse randomized to (1) vaginal hysterectomy with uterosacral ligament suspension or (2) vaginal mesh hysteropexy underwent pelvic magnetic resonance imaging (MRI) at 30-42 months post-surgery. Standardized protocols have been developed to systematize MRI examinations across multiple sites and to improve reliability of MRI measurements. Anatomical failure, based on MRI, is defined as prolapse beyond the hymen. Anatomic measures from co-registered rest, maximal strain, and post-strain rest (recovery) sequences are obtained from the "true mid-sagittal" plane defined by a 3D pelvic coordinate system. The primary outcome is the mechanism of failure (apical descent versus anterior vaginal wall elongation). Secondary outcomes include displacement of the vaginal apex and perineal body and elongation of the anterior wall, posterior wall, perimeter, and introitus of the vagina between (1) rest and strain and (2) rest and recovery., Results: Recruitment and MRI trials of 94 participants were completed by May 2018., Conclusions: Methods papers which detail studies designed to evaluate anatomic outcomes of prolapse surgeries are few. We describe a systematic, standardized approach to define and quantitatively assess mechanisms of anatomic failure following prolapse repair. This study will provide a better understanding of how apical prolapse repairs fail anatomically.

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

Objective: The aim of the study was to compare the prevalence of adverse childhood experiences (ACEs) in women with overactive bladder (OAB) or interstitial cystitis/bladder pain syndrome (IC/BPS) to age-matched controls., Methods: This case-control study compared numbers and types of ACEs in women with OAB or IC/BPS compared with controls based on the Center for Disease Control's Behavioral Risk Factor Surveillance System ACE Module. Participants completed demographic forms, condition-specific symptom questionnaires, and the ACE Module (11 questions summarizing traumatic exposures occurring before the age of 18 years). Cases and controls were compared using χ2 and t tests, significance level P < 0.05., Results: Three hundred twenty-two women were enrolled from April 2018 to March 2019; OAB = 91 cases and 91 controls, IC/BPS = 70 cases and 70 controls. Overactive bladder group's mean age was 56 ± 13 years, and IC/BPS was 46 ± 13 years. Compared with controls, OAB and IC/BPS cases differed in race/ethnicity and education (P < 0.02), history of substance abuse (P ≤ 0.03), and median numbers of ACEs (OAB 3, controls 1; IC/BPS 4, controls 2, P < 0.01). Cases had increased odds of having 4 or more ACEs, a parameter known to be associated with poor health and longevity, and increased greater than 2-fold in OAB and greater than 7-fold in IC/BPS. Interstitial cystitis/bladder pain syndrome cases had notably increased odds of exposure to abuse (physical/emotional/sexual) and witnessed domestic violence (all P < 0.01)., Conclusions: Overactive bladder and IC/BPS cases reported increased ACE exposures; more than one-third of OAB and more than IC/BPS cases reported 4 or more ACES, a threshold associated with poor health outcomes. Recognition of increased childhood adversity in OAB and IC/BPS has important treatment and health implications., Competing Interests: Y.K. received research funding support from Cook-Myosite and Eunice Shriver NICHD. C.N. received research funding support from Cook-Myosite. P.J. is a consultant for Ethicon. K.M. received Society of Gynecologic Surgeons board member travel reimbursement, Elsevier royalties for editing and authorship, and is consultant for RBI Medical. G.D. received research funding support from Pelvalon and Viveve and travel reimbursement from ACOG and ABOG. The other authors have declared they have no conflicts of interest., (Copyright © 2020 American Urogynecologic Society. All rights reserved.)

Objectives: Peer counseling may improve upon provider counseling and enhance patient preparedness for midurethral sling (MUS) surgery. We aimed to compare the impact of peer-centered versus standard preoperative video counseling by assessing patient preparedness for MUS surgery., Methods: Women undergoing MUS were randomized to view either a peer-centered (PEER) or standard physician preoperative counseling video (PHYS). The PEER video featured a woman who had undergone MUS surgery and included the standard risks and benefits as well as additional information identified in prior work as important to patients. The PHYS video featured a surgeon discussing risks and benefits. Patients viewed either video at their preoperative visit and completed the Patient Preparedness Questionnaire (PPQ), Surgical Decision Satisfaction, Decisional Regret Scale, and the Urogenital Distress Inventory Short Form. Patients then underwent standard in-person surgeon counseling. Sessions were timed and compared with historical timed sessions. Our primary outcome was between-group differences in 6-week postoperative PPQ scores., Results: Patient Preparedness Questionnaire scores did not differ between groups (postoperative PPQ scores: median [interquartile range], 95 [84, 100] vs 92 [80, 100]; P=0.50). The PEER group reported higher decisional regret (15 [0, 28.75] vs 0 [0, 10], P=0.02) and less symptom improvement on Urogenital Distress Inventory Short Form change scores compared with the PHYS group (47.2 [37.2, 62.5] vs 36.1 [16.5, 50], P=0.03); secondary outcomes were not different between groups. In-person counseling times decreased after watching either video compared with the institution's historical standard (8:27 minutes [08:56, 17:14] vs 11:34 minutes [5:22, 13:07]; P < 0.005)., Conclusion: Patient preparedness did not differ between groups. Decision regret did not differ between groups once adjusted for urinary symptoms.

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., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Objective: To evaluate the prevalence and severity of urinary incontinence (UI) in women who participate in CrossFit classes compared with women who participate in non-CrossFit group fitness classes., Methods: The authors conducted a cross-sectional study of women who participate in either CrossFit or non-CrossFit group fitness classes using an online survey. Participants provided demographic information and completed the Incontinence Severity Index and Urinary Distress Inventory. Participants were recruited from local CrossFit and non-CrossFit gyms, online via social media, and an electronic CrossFit Newsletter. Associated comorbidities, exercises associated with UI, and coping mechanisms for urinary leakage were also assessed., Results: Four hundred twenty-three women meeting inclusion criteria completed the survey, including 322 CrossFit participants and 101 non-CrossFit participants. We found that CrossFit participants were older than non-CrossFit participants and more likely to self-identify as non-Hispanic white. CrossFit participants more commonly reported UI (84% vs 48%, P = <0.001), higher severity of UI (Urinary Distress Inventory score: 20.8 vs 12.5, P < 0.001), and specifically more stress UI (73% vs 47%, P < 0.001). Weightlifting and jumping movements were the most common exercises associated with UI in CrossFit participants. Age and participation in CrossFit are significant and independent predictors of UI., Conclusions: More than 80% of CrossFit participants reported UI and half of these reported moderate-severe UI, as compared with women who participate in non-CrossFit classes, less than half of whom reported UI with a small minority reporting moderate-severe UI. Exercises most associated with UI were jumping and weightlifting.

Background: Urgency urinary incontinence afflicts many adults, and most commonly affects women. Medications, a standard treatment, may be poorly tolerated, with poor adherence. This warrants investigation of alternative interventions. Mind-body therapies such as hypnotherapy may offer additional treatment options for individuals with urgency urinary incontinence., Objective: To evaluate hypnotherapy's efficacy compared to medications in treating women with urgency urinary incontinence., Materials and Methods: This investigator-masked, noninferiority trial compared hypnotherapy to medications at an academic center in the southwestern United States, and randomized women with non-neurogenic urgency urinary incontinence to weekly hypnotherapy sessions for 2 months (and continued self-hypnosis thereafter) or to medication and weekly counseling for 2 months (and medication alone thereafter). The primary outcome was the between-group comparison of percent change in urgency incontinence on a 3-day bladder diary at 2 months. Important secondary outcomes were between-group comparisons of percent change in urgency incontinence at 6 and 12 months. Outcomes were analyzed based on noninferiority margins of 5% for between group differences (P < 0.025) (that is, for between group difference in percentage change in urgency incontinence, if the lower bound of the 95% confidence interval was greater than -5%, noninferiority would be proved)., Results: A total of 152 women were randomized to treatment between April 2013 and October 2016. Of these women, 142 (70 hypnotherapy, 72 medications) had 3-day diary information at 2 months and were included in the primary outcome analysis. Secondary outcomes were analyzed for women with diary data at the 6-month and then 12-month time points (138 women [67 hypnotherapy, 71 medications] at 6 months, 140 women [69 hypnotherapy, 71 medications] at 12 months. There were no differences between groups' urgency incontinence episodes at baseline: median (quartile 1, quartile 3) for hypnotherapy was 8 (4, 14) and medication was 7 (4, 11) (P = .165). For the primary outcome, although both interventions showed improvement, hypnotherapy did not prove noninferior to medication at 2 months. Hypnotherapy's median percent improvement was 73.0% (95% confidence interval, 60.0-88˖9%), whereas medication's improvement was 88.6% (95% confidence interval, 78.6-100.0%). The median difference in percent change between groups was 0% (95% confidence interval, -16.7% to 0.0%); because the lower margin of the confidence interval did not meet the predetermined noninferiority margin of greater than -5%, hypnotherapy did not prove noninferior to medication. In contrast, hypnotherapy was noninferior to medication for the secondary outcomes at 6 months (hypnotherapy, 85.7% improvement, 95% confidence interval, 75.0-100%; medications, 83.3% improvement, 95% confidence interval, 64.7-100%; median difference in percent change between groups of 0%, 95% confidence interval, 0.0-6.7%) and 12 months (hypnotherapy, 85.7% improvement, 95% confidence interval, 66.7-94.4%; medications, 80% improvement, 95% confidence interval, 54.5-100%; median difference in percent change between groups of 0%, 95% confidence interval, -4.2% to -9.5%)., Conclusion: Both hypnotherapy and medications were associated with substantially improved urgency urinary incontinence at all follow-up. The study did not prove the noninferiority of hypnotherapy compared to medications at 2 months, the study's primary outcome. Hypnotherapy proved noninferior to medications at longer-term follow-up of 6 and 12 months. Hypnotherapy is a promising, alternative treatment for women with UUI., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Introduction and Hypothesis: Patient perception of adverse events (AEs) after pelvic floor disorder surgery is incompletely understood and may differ from providers' views of AEs. Our objective is to describe patient perceptions of AEs related to pelvic floor disorder surgery and how perceptions change over time., Methods: Mixed-method study of longitudinal patient interviews and surveys. Women planning pelvic floor disorder surgery completed three one-on-one interviews: preoperatively (< 12 weeks before surgery), 6-8 weeks postoperatively, and 6 months postoperatively. Interviews explored the patient experience of surgery and their perception of AEs over time. Participants ranked self-identified AEs by severity. De-identified transcripts of audio recordings were coded and analyzed using an iterative, thematic, team-based process using NVivo software (QSR International)., Results: Twenty women each completed three separate interviews for a total of 60 interviews. Their mean age was 55.3 (± 12.7) years, and 50% were Non-Hispanic white. Women's perceptions of AEs changed as more time passed from surgery. Women identified potential problems related to surgery such as anesthesia complications, pain, injury, catheter issues, and an unsuccessful surgery as the most concerning AEs preoperatively. Postoperatively (6-8 weeks), women expressed concern about functional outcomes (e.g., performing daily activities, symptom reduction). Late postoperatively (6 months), the majority identified unsuccessful surgery, incontinence, and sexual dysfunction as severe AEs. These findings are consistent with prior work that suggests women perceive functional outcomes as fundamental to their recovery., Conclusions: These findings contribute to a more nuanced understanding of patient-centered perspectives on AEs. Patients view poor functional outcomes as severe AEs.

Objective: To compare adverse childhood experiences (ACEs) in women with chronic pelvic pain with a control group, and describe occurrence of specific ACEs in women with chronic pelvic pain., Methods: This case-control study examined the relationship between history of ACEs, traumatic events occurring during childhood as defined by the Centers for Disease Control and Prevention (CDC), and chronic pelvic pain. Patients diagnosed with chronic pelvic pain (n=60) were age-matched to a control group of women without chronic pelvic pain (n=60). All participants completed validated measures to detect for presence of any of the 11 ACEs as identified by the CDC's Behavioral Risk Factor Surveillance System ACE Module., Results: Mean participant age was 40 (±11 years). Total numbers of ACEs were elevated in chronic pelvic pain participants compared with a control group (median 4 [interquartile range 2-6] vs median 1 [interquartile range 0-4], P<.001) and 53% of chronic pelvic pain participants had four or more ACEs, compared with 27% of the control group (odds ratio [OR] 3.14; 95% CI 1.46-6.75). All categories of abuse were more prevalent in chronic pelvic pain compared with the control group: physical (43% vs 15%, OR 4.3; 95% CI 1.8-10.4; P=.001), sexual (55% vs 23%, OR 4.0; 95% CI 1.8-8.8; P<.001) and verbal or emotional (62% vs 33%, OR 3.2; 95% CI 1.5-6.8; P=.003). Regarding household challenges, the subcategory most prevalent in chronic pelvic pain participants compared with the control group was that of witnessed domestic violence (35% vs 8%, OR 5.9; 95% CI 2.1-17.1, P<.001)., Conclusion: Chronic pelvic pain participants had a greater than threefold odds of having a history of childhood abuse and having witnessed domestic violence during childhood compared with the control group. Women with chronic pelvic pain had increased numbers of ACEs and 53% had four or more ACEs, crossing a threshold that others have found to predict poor overall health outcomes.

Introduction and Hypothesis: Our aim was to determine whether postoperative telephone follow-up was noninferior to in-person clinic visits based on patient satisfaction. Secondary outcomes were safety and clinical outcomes., Methods: Women scheduled for pelvic surgery were recruited from a single academic institution and randomized to clinic or telephone follow-up. The clinic group returned for visits 2, 6, and 12 weeks postoperatively and the telephone group received a call from a nurse at the same time intervals. Women completed the Consumer Assessment of Healthcare Providers and Systems Surgical Care Survey (S-CAHPS) questionnaire, Pelvic Floor Distress Inventory (PFDI)-20, and pain scales prior to and 3 months postoperatively. Randomized patients who completed the S-CAHPS at 3 months were included for analysis. Sample size calculations, based on a 15% noninferiority limit in the S-CAHPS global assessment surgeon rating, required 100 participants, with power = 80% and alpha = 0.025., Results: From October 2016 to November 2017, 100 participants were consented, underwent surgery, were randomized, and included in the final analysis (clinic group n = 50, telephone group n = 50). Mean age was 58.5 ± 12.2 years. Demographic data and surgery type, dichotomized into outpatient and inpatient, did not differ between groups. The S-CAHPS global assessment surgeon rating from patients in the telephone group was noninferior to the clinic group (92 vs 88%, respectively, rated their surgeons 9 and10, with a noninferiority limit of 36.1; p = 0.006). Adverse events did not differ between groups (n = 26; 57% fclinic vs 43% telephone; p = 0.36). Patients in the telephone group did not require additional emergency room or primary care visits. Clinical outcome measures improved in both groups, with no differences (all p > 0.05)., Conclusions: Telephone follow-up after pelvic floor surgery results in noninferior patient satisfaction, without differences in clinical outcomes or adverse events. Telephone follow-up may improve healthcare quality and decrease patient and provider burden for postoperative care., Clinical Trial Registration: ClinicalTrials.gov , www.clinicaltrials.gov , NCT02891187.

Introduction and Hypothesis: Rectopexy and sacrocolpopexy can be performed concurrently to treat rectal and vaginal prolapse. We hypothesized that concurrent procedures might be associated with more complications than rectopexy and sacrocolpopexy alone., Methods: Patients undergoing laparoscopic sacrocolpopexy or rectopexy, or concurrent laparoscopic sacrocolpopexy and rectopexy were identified in the American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) database from 2013 to 2016. Preoperative characteristics, operative time, and 30-day post-operative complications were compared between groups. Complications were those defined by the ACS Risk Calculator. Descriptive tests and regression methods were utilized for group comparisons. Significance was set at p < 0.05., Results: We identified 7,232 laparoscopic sacrocolpopexy, 1,560 laparoscopic rectopexy, and 123 concurrent laparoscopic sacrocolpopexy and rectopexy cases. Patients undergoing concurrent procedures were more commonly white, non-Hispanic, non-diabetic, and smokers. Operative time was longest for concurrent procedures, followed by sacrocolpopexy and rectopexy (p < 0.0001). Patients undergoing isolated rectopexy were more commonly ≥ American Society of Anesthesiologists class 3 (p < 0.0001). Rates of any complication for colpopexy, rectopexy, and concurrent procedures did not differ (6.18%, 7.63%, 8.94%; p = 0.058). Serious complication rates for colpopexy, rectopexy, and concurrent procedures did not differ (5.52%, 6.35%, 8.13%; p = 0.222). Odds of experiencing any complication were higher comparing rectopexy with colpopexy alone (adjusted odds ratio = 1.252, 95% CI 1.002-1.565). Comparing all groups, rectopexy had the highest mortality, reoperation, and transfusion rates (all p < 0.05). Concurrent procedures had the highest surgical site and urinary tract infection rates (all p < 0.05)., Conclusions: Complications were low for all three procedures. Concurrent repair may be appropriate in well-selected patients.

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.

Background: The opioid epidemic in the United States is a public health emergency. Minimally invasive surgical technology has decreased length of hospital stay, improved postoperative recovery, and decreased postoperative pain. Hysterectomy is one of the most commonly performed surgeries in the United States. Increasing trends in minimally invasive gynecologic surgery are expected to reduce patients' postoperative pain. It is unclear whether this assumption has resulted in decreasing postoperative opioid prescriptions or patient need for these prescriptions, as prescribing patterns may be contributing to the current opioid public health emergency., Objective: We sought to describe opioid prescribing and patient procurement practices for postoperative pain at time of discharge for benign hysterectomy from 2004 through 2014 using the Truven Health Analytics MarketScan Research Database. The trends of the route of hysterectomy over this time period were concomitantly described to reflect the movement toward more minimally invasive approaches., Study Design: The Truven Health Analytics MarketScan Research Database including the Commercial Claims and Encounters Database, and the Medicare Supplemental and Coordination of Benefits Database were utilized. Current Procedural Terminology, 4th Edition, and International Classification of Diseases, Ninth Revision, codes identified all patients who underwent a hysterectomy for benign indications from 2004 through 2014. Hysterectomy routes were categorized into abdominal, laparoscopic, and vaginal. The MarketScan database captures prescriptions filled at a retail or mail-order pharmacy and does not capture prescriptions filled within the inpatient, hospital facility. The days of opioids procured by patients at the time of discharge were identified for each encounter. Descriptive statistics were used to summarize data within the entire study period. Although this article is purely descriptive, further analyses were conducted for exploratory purposes only. analysis of variance and χ 2 analyses were used for continuous and categorical variables, respectively. Multiple linear regression models were used to describe associations between variables of interest and postoperative opioid prescriptions., Results: We identified 793,016 patients who underwent a hysterectomy for benign indications from 2004 through 2014. Of these, 96% were identified from the Commercial Claims and Encounters Database. During the study period, the overall route of hysterectomy was categorized into 40.5% abdominal, 42.0% laparoscopic, and 17.5% vaginal hysterectomy. The route of hysterectomy changed from 60.2-25.6% (a decrease of Δ = 34.58; 95% confidence interval, 33.96-35.20) for abdominal, 17.0-61.9% (an increase of Δ = 44.83; 95% confidence interval, 44.21-45.44) for laparoscopic, and 22.8-12.6% (a decrease of Δ = 10.25; 95% confidence interval, 9.77-10.73) for vaginal. At discharge, the percentage of patients who were prescribed opioids and filled them increased from 25.6-82.1% (an increase of Δ = 56.50; 95% confidence interval, 55.88-57.13 with P < .001) from 2004 through 2014 for all hysterectomy routes. Additionally, the quantity of opioids prescribed also increased., Conclusion: Opioid prescriptions filled for postoperative pain after hysterectomy substantially increased from 2004 through 2014. Opioid prescription procurement has increased despite a concomitant increase in minimally invasive hysterectomy routes. In light of the current opioid epidemic, physicians must recognize that postoperative prescribing practices may contribute to chronic opioid use. Heightened awareness of opioid prescribing practices following surgery is critically important to decrease risk of development of chronic opioid dependence., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Background: Urgency urinary incontinence (UUI) is a chronic condition for which sacral neuromodulation (SNM) (InterStim/Medtronic) and onabotulinumtoxinA (BTX) (BotoxA/Allergan) are utilized. These therapies have not been compared over extended time., Objective: To compare UUI episodes (UUIE) over 24 mo following SNM or BTX., Design, Setting, and Participants: Multicenter, open-label, randomized, extension trial (February 2012-July 2016) at nine US medical centers involving 386 women with ≥6 UUIE over 3 d inadequately managed by medications. Participants were clinical responders to treatment: ≥50% reduction in UUIEs after SNM placement or 1 mo post BTX., Intervention: SNM (n=194) versus 200 U BTX (n=192). SNM reprogrammings occurred throughout the 24 mo. After 6 mo, two additional BTX injections were allowed., Outcome Measurements and Statistical Analysis: Primary outcome: change in mean daily UUIE over 24 mo., Secondary Outcomes: no UUIE, ≥75% and ≥50% UUIE reduction; Overactive Bladder Questionnaire Short Form; Urinary Distress Inventory short form; Incontinence Impact Questionnaire; Patient Global Impression of Improvement; Overactive Bladder Satisfaction of Treatment Questionnaire; and adverse events (AEs). Primary analysis used a linear mixed model., Results and Limitations: Outcome data were available for 260/298 (87%) clinical responders. No difference in decreased mean UUIE was found over 24 mo (-3.88 vs -3.50 episodes/d,95% confidence interval [CI]=-0.14-0.89; p=0.15), with no differences in UUI resolution, ≥75% or ≥50% UUIE reduction. BTX group maintained higher satisfaction (mean difference=-9.14, 95% CI=-14.38--3.90; p<0.001), treatment endorsement (mean difference=-12.16, 95% CI=-17.7--6.63; p<0.001) through 24 mo. Other secondary measures did not differ. Recurrent urinary tract infections (UTIs) were higher after BTX (24% vs 10%; p<0.01), 6% required intermittent catheterization post second injection. SNM revision and removals occurred in 3% and 9% patients, respectively., Conclusions: Both treatments offered sustainable UUI improvement, and higher BTX dosing had low clean intermittent catheterization rates, but with UTI risk. SNM revision/removal rates were low due to standardized lead placement with strict treatment response definitions., Patient Summary: We compared a large group of US women with severe urgency urinary incontinence (UUI) who received sacral neuromodulation (InterStim) or onabotulinumtoxinA (Botox A) therapy during a 2-yr period. We found that both therapies had similar success in reducing UUI symptoms, and adverse events were low. However, women in the BotoxA group had higher satisfaction and endorsement with their treatment, but with a higher chance of a urinary tract infection. We conclude that both therapies offer sustained reduction in daily incontinence over 2 yr., (Copyright © 2018 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Objectives: The aims of this study were to describe relationships between women given a diagnosis of nocturnal enuresis (NE) and controls without any urinary complaints and to compare women with NE with those with overactive bladder (OAB). We hypothesized that NE has unique associations with demographics and medical and psychosocial diagnoses., Methods: This is a secondary analysis of a database that included all female veterans who established care with a primary care provider from 1997 to 2015. International Classification of Diseases, Ninth Revision, codes identified women with a diagnosis of NE or OAB. Patient characteristics, medical diagnoses, and psychosocial factors previously described as relating to NE and/or OAB were compared between the 2 distinct comparative groups, with significance set at P < 0.05. Stepwise logistic regression was used to assess all significant findings., Results: A total of 596,815 women were identified; controls totaled 570,049, the group with OAB totaled 26,446 (4.4%), and the group with NE totaled 301 (0.05%).Multivariable analysis compared the group with NE with controls; all measured psychosocial characteristics remained significantly associated with an NE diagnosis (all Ps < 0.05), as well as obstructive sleep apnea history, stroke, self-identification as "minority," smoking, hypertension, and a body mass index higher than those of the general control population (all Ps < 0.05).When the populations with NE and OAB were compared, a diagnosis of posttraumatic stress disorder, an overdose history, depression, military sexual trauma, increasing body mass index, and younger age remained significantly associated with NE (all Ps < 0.05)., Conclusions: The association of NE with psychosocial characteristics and psychiatric illnesses persisted irrespective of the comparison population. Practitioners should investigate the diagnosis of NE in those female veterans with psychosocial issues.

Background: Women with refractory urgency urinary incontinence (ie, unresponsive to behavioral and pharmacological interventions) are treated with onabotulinumtoxinA or sacral neuromodulation., Objective: The objective of the study was to compare treatment efficacy and adverse events in women <65 and ≥65 years old treated with onabotulinumtoxinA or sacral neuromodulation., Study Design: This study was a planned secondary analysis of a multicenter, randomized trial that enrolled community-dwelling women with refractory urgency urinary incontinence to onabotulinumtoxinA or sacral neuromodulation treatments. The primary outcome was a change in mean daily urgency urinary incontinence episodes on a bladder diary over 6 months. Secondary outcomes included ≥75% urgency urinary incontinence episode reduction, change in symptom severity/quality of life, treatment satisfaction, and treatment-related adverse events., Results: Both age groups experienced improvement in mean urgency urinary incontinence episodes per day following each treatment. There was no evidence that mean daily urgency urinary incontinence episode reduction differed between age groups for onabotulinumtoxinA (adjusted coefficient, -0.127, 95% confidence interval, -1.233 to 0.979; P = .821) or sacral neuromodulation (adjusted coefficient, -0.698, 95% confidence interval, -1.832 to 0.437; P = .227). Among those treated with onabotulinumtoxinA, women <65 years had 3.3-fold greater odds of ≥75% resolution than women ≥65 years (95% confidence interval, 1.56 -7.02). Women <65 years had a greater reduction in Overactive Bladder Questionnaire Short Form symptom bother scores compared with women ≥65 years by 7.49 points (95% confidence interval, -3.23 to -11.74), regardless of treatment group. There was no difference between quality of life improvement by age. Women ≥65 years had more urinary tract infections following onabotulinumtoxinA and sacral neuromodulation (odds ratio, 1.9, 95% confidence interval, 1.2-3.3). There was no evidence of age differences in sacral neuromodulation revision/removal or catheterization following onabotulinumtoxinA treatment., Conclusion: Younger women experienced greater absolute continence, symptom improvement, and fewer urinary tract infections; both older and younger women had beneficial urgency urinary incontinence episode reduction, similar rates of other treatment adverse events, and improved quality of life., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Introduction and Hypothesis: We describe the rationale and methodology for a study comparing mind-body treatment and pharmacotherapy in women with urgency urinary incontinence (UUI). To explore brain associations in UUI, a subset of patients will also undergo functional magnetic resonance imaging (fMRI). We hypothesize that hypnotherapy, a mind-body intervention, will be at least as effective as pharmacotherapy in treating UUI. We also hypothesize that fMRI findings will change following treatment, with changes potentially differing between groups., Methods: We describe the development and design challenges of a study comparing the efficacy of hypnotherapy and conventional pharmacotherapy in the treatment of UUI. The study randomizes women to either of these treatments, and outcome measures include bladder diaries and validated questionnaires. Sample size estimates, based on a noninferiority test (alpha = 0.025, beta = 0.20), after considering dropout subjects and subjects lost to follow-up, indicated that approximately 150 woman would be required to test the hypothesis that hypnotherapy is not inferior to pharmacotherapy within a 5 % noninferiority margin. The study will also evaluate fMRI changes in a subset of participants before and after therapy. Challenges included designing a study with a mind-body therapy and a comparison treatment equally acceptable to participants, standardizing the interventions, and confronting the reality that trials are time-consuming for participants who have to make appropriate accommodations in their schedule., Results: Study enrollment began in March 2013 and is ongoing., Conclusions: We describe the design of a randomized controlled trial comparing mind-body therapy and pharmacotherapy in the treatment of UUI and the challenges encountered in its implementation.

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.

Introduction: Interstitial cystitis/bladder pain syndrome (IC/BPS) is a poorly understood source of chronic pain causing significant morbidity, with variable treatment success. Despite the need to understand patient perspectives in chronic pain, there is a paucity of qualitative data for IC/BPS. We aimed to acquire information regarding patient experience with IC/BPS symptoms and with their medical care to elicit suggestions to improve patient satisfaction with that care., Methods: Fifteen women with IC/PBS participated in a total of four focus groups. Sessions were recorded and transcribed and information deidentified. Focus groups were conducted until thematic saturation was reached. All transcripts were coded and analyzed by a minimum of three independent physician reviewers. Investigators identified emergent themes and concepts using grounded-theory methodology., Results: Participant's mean age was 52.6 years, with an average IC/BPS duration of 6.3 years. Thematic saturation was reached after four focus groups. We identified three emergent patient experience concepts: IC/PBS is debilitating, the disease course is unpredictable and unrelenting, and patients experience significant isolation. Importantly, suicidal ideation was expressed in each group. Patients voiced strong preference for physicians who provided education regarding the condition, an array of treatment options, organized treatment plans, and optimism and hope regarding treatment outcomes., Conclusions: Our study presents novel findings of the importance of patient-physician interaction in IC/BPS and reinforces the tremendous disability and burden of this disease, which frequently manifests in suicidal ideation. Patients preferred organized treatment plans with diverse choices and providers who offered hope in dealing with their condition., Competing Interests: Financial Disclosures/Conflicts of Interest: KA Volpe-None SB Cichowski-None PC Jeppson-None Y Komesu-None

Introduction and Hypothesis: Mindfulness-based stress reduction (MBSR) is a standardized meditation program that may be an effective therapy for interstitial cystitis/bladder pain syndrome (IC/BPS), a condition exacerbated by stress. The aims of this study were to explore whether MBSR improved IC/BPS symptoms and the feasibility/acceptability of MSBR among women with IC/BPS., Methods: This randomized controlled trial included women with IC/BPS undergoing first- or second-line therapies. Women were randomized to continuation of usual care (UC) or an 8-week MBSR class + usual care (MBSR). Participants completed baseline and 8-week post-treatment questionnaires, including the O'Leary-Sant Symptom Problem Index (OSPI), the visual analog pain scale (VAS), the Short Form Health Survey (SF-12), the Female Sexual Function Index (FSFI), and the Pain Self-Efficacy Questionnaire (PSEQ). The Global Response Assessment (GRA) was completed post-treatment. Analyses were performed using Student's t test, Chi-squared, and MANOVA where appropriate., Results: Eleven women were randomized to UC and 9 to MBSR, without differences in group characteristics. More MBSR participants' symptoms were improved on the GRA (7 out of 8 [87.5 %] vs 4 out of 11 [36.4 %], p = 0.03). The MBSR group showed greater improvement in the OSPI total (p = 0.0498) and problem scores (p = 0.036); the OSPI symptom score change did not differ. PSEQ scores improved in MBSR compared with UC (p = 0.035). VAS, SF-12, and FSFI change did not differ between groups. Eighty-six percent of MBSR participants felt more empowered to control symptoms, and all participants planned to continue MBSR., Conclusions: This trial provides initial evidence that MBSR is a promising adjunctive therapy for IC/BPS. Its benefit may arise from patients' empowerment and ability to cope with symptoms., Competing Interests: Financial Disclosures/Conflicts of Interest: G. Kanter-None Y Komesu-None F Qaedan-None GC Dunivan-None PC Jeppson-None SB Cichowski-None RG Rogers-DSMB Chair for the TRANSFORM trial sponsored by American Medical Systems, UptoDate royalties, Royalties from McGraw Hill for a textbook

Objectives: This study aimed to describe the relationship between genital hiatus (GH) and perineal body (PB) measurements with increasing pelvic organ prolapse (POP) stage in a large cohort of women referred to Urogynecology clinic for pelvic floor disorders., Methods: Retrospective chart review of all new patients seen in an academic Urogynecology clinic between January 2007 and September 2011 was performed. Data were extracted from a standardized intake form. All patients underwent a Pelvic Organ Prolapse Quantification (POPQ) examination. Descriptive statistics compared the study population. Analysis of variance was used to compare GH and PB measurements by prolapse stage. Fisher least significant differences were used for post hoc comparisons of means between prolapse stages. Pearson correlations were used to evaluate the associations between GH and PB measurements and patient characteristics., Results: A total of 1595 women with POPQ examinations comprised the study population. The mean age was 55.3 ± 14.8 years with a body mass index of 30.3 ± 7.6 kg/m, most women were parous (90%), 40% were Hispanic, and 33% had undergone prior hysterectomy for indications exclusive of POP. Women with any prior prolapse repair were excluded, 6.5% had a prior incontinence procedure. Perineal body measurements were slightly larger for stage 2 POP, but overall did not vary across other prolapse stages (all P > 0.05). In contrast, GH measurements increased through stage 3 POP, GH measurements decreased for stage 4 POP., Conclusions: Mean PB measurements did not demonstrate large changes over prolapse stage, whereas GH measurements increased through stage 3 POP. Genital hiatus serves as an important marker for underlying pelvic muscle damage.

Background: Physicians and hospital systems often have relationships with biomedical manufacturers to develop new ideas, products, and further education. Because this relationship can influence medical research and practice, reporting disclosures are necessary to reveal any potential bias and inform consumers. The Sunshine Act was created to develop a new reporting system of these financial relationships called the Open Payments database. Currently all disclosures submitted with research to scientific meetings are at the discretion of the physician. We hypothesized that financial relationships between authors and the medical industry are underreported., Objectives: We aimed to describe concordance between physicians' financial disclosures listed in the abstract book from the 41st annual scientific meeting of the Society of Gynecologic Surgeons to physician payments reported to the Center for Medicaid and Medicare Services Open Payments database for the same year., Study Design: Authors and scientific committee members responsible for the content of the 41st annual scientific meeting of the Society of Gynecologic Surgeons were identified from the published abstract book; each abstract listed disclosures for each author. Abstract disclosures were compared with the transactions recorded on the Center for Medicaid and Medicare Services Open Payments database for concordance. Two authors reviewed each nondisclosed Center for Medicaid and Medicare Services listing to determine the relatedness between the company listed on the Center for Medicaid and Medicare Services and abstract content., Results: Abstracts and disclosures of 335 physicians meeting inclusion criteria were reviewed. A total of 209 of 335 physicians (62%) had transactions reported in the Center for Medicaid and Medicare Services, which totaled $1.99 million. Twenty-four of 335 physicians (7%) listed companies with their abstracts; 5 of those 24 physicians were concordant with the Center for Medicaid and Medicare Services. The total amount of all nondisclosed transactions was $1.3 million. Transactions reported in the Center for Medicaid and Medicare Services associated with a single physician ranged from $11.72 to $405,903.36. Of the 209 physicians with Center for Medicaid and Medicare Services transactions that were not disclosed, the majority (68%) had at least 1 company listed in the Center for Medicaid and Medicare Services that was determined after review to be related to the subject of their abstract., Conclusion: Voluntary disclosure of financial relationships was poor, and the majority of unlisted disclosures in the abstract book were companies related to the scientific content of the abstract. Better transparency is needed by physicians responsible for the content presented at gynecological scientific meetings., Competing Interests: JC Thompson reports no conflict of interest KA Volpe reports no conflict of interest LK Bridgewater reports no conflict of interest F Qeadan reports no conflict of interest, (Copyright © 2016 Elsevier Inc. All rights reserved.)

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.

Background: Treatment of urgency urinary incontinence has focused on pharmacologically treating detrusor overactivity. Recent recognition that altered perception of internal stimuli (interoception) plays a role in urgency urinary incontinence suggests that exploration of abnormalities of brain function in this disorder could lead to better understanding of urgency incontinence and its treatment., Objective: We sought to: (1) evaluate the relationship between bladder filling, perceived urgency, and activation at brain sites within the interoceptive network in urgency urinary incontinence; (2) identify coactivation of other brain networks that could affect interoception during bladder filling in urgency incontinence; and (3) demonstrate interaction between these sites prior to bladder filling by evaluating their resting-state connectivity., Study Design: We performed an observational cohort study using functional magnetic resonance imaging to compare brain function in 53 women with urgency urinary incontinence and 20 controls. Whole-brain voxelwise analyses of covariance were performed to examine differences in functional brain activation between groups during a task consisting of bladder filling, hold (static volume), and withdrawal phases. The task was performed at 3 previously established levels of baseline bladder volume, the highest exceeding strong desire to void volume. All women continuously rated their urge on a 0- to 10-point Likert scale throughout the task and a mixed measures analysis of variance was used to test for differences in urge ratings. Empirically derived regions of interest from analysis of activation during the task were used as seeds for examining group differences in resting-state functional connectivity., Results: In both urgency urinary incontinent participants and controls, changes in urge ratings were greatest during bladder filling initiated from a high baseline bladder volume and urgency incontinent participants' rating changes were greater than controls. During this bladder-filling phase urgency incontinent participant's activation of the interoceptive network was greater than controls, including in the left insula and the anterior and middle cingulate cortex. Urgency incontinent participant's activation was also greater than controls at sites in the ventral attention network and posterior default mode network. Urgency incontinent participant's connectivity was greater than controls between a middle cingulate seed point and the dorsal attention network, a "top-down" attentional network. Control connectivity was greater between the midcingulate seed point and the ventral attention network, a "bottom-up" attentional network., Conclusion: Increasing urge was associated with greater urgency incontinent participant than control activation of the interoceptive network and activation in networks that are determinants of self-awareness (default mode network) and of response to unexpected external stimuli (ventral attention network). Differences in connectivity between interoceptive networks and opposing attentional networks (ventral attention network vs dorsal attention network) were present even before bladder filling (in the resting state). These findings are strong evidence for a central nervous system component of urgency urinary incontinence that could be mediated by brain-directed therapies., (Copyright © 2016 Elsevier Inc. All rights reserved.)

This is a randomized, controlled, blind, crossover trial comparing cycling versus continuous programming of a sacral neuromodulator in women diagnosed with overactive bladder (OAB). At 6 months, treatment order significantly affected Overactive Bladder Questionnaire - Short Form (OABq-SF) symptom scores. The cycling followed by continuous stimulation group had superior OABq-SF scores (p > 0.02).

Introduction and Hypothesis: Urinary incontinence (UI) is common and the relationship among its subtypes complex. Our objective was to describe the natural history and predictors of the incontinence subtypes stress, urgency, and mixed, in middle-aged and older US women. We tested our hypothesis that UI subtype history predicted future occurrence, evaluating subtype incidence/remission over multiple time points in a stable cohort of women., Methods: We analyzed longitudinal urinary incontinence data in 10,572 community-dwelling women aged ≥50 in the 2004-2010 Health and Retirement Study. Mixed, stress, and urgency incontinence prevalence (2004, 2006, 2008, 2010) and 2-year cumulative incidence and remissions (2004-2006, 2006-2008, 2008-2010) were estimated. Patient characteristics and incontinence subtype status 2004-2008 were entered into a multivariable, transition model to determine predictors for incontinence subtype occurrence in 2010., Results: The prevalence of each subtype in this population (median age 63-66) was 2.6-8.9 %. Subtype incidence equaled 2.1-3.5 % and remissions for each varied between 22.3 and 48.7 %. Incontinence subtype incidence predictors included ethnicity/race, age, body mass index, and functional limitations. Compared with white women, black women had decreased odds of incident stress incontinence and Hispanic women had increased odds of stress incontinence remission. The age range 80-90 and severe obesity predicted incident mixed incontinence. Functional limitations predicted mixed and urgency incontinence. The strongest predictor of incontinence subtype was subtype history. The presence of the respective incontinence subtypes in 2004 and 2006 strongly predicted 2010 recurrence (odds ratio [OR] stress incontinence = 30.7, urgency OR = 47.4, mixed OR = 42.1)., Conclusions: Although the number of remissions was high, a previous history of incontinence subtypes predicted recurrence. Incontinence status is dynamic, but tends to recur over the longer term.

Introduction: Pessaries are commonly used to treat pelvic floor disorders, but little is known about the sexual function of pessary users., Aim: We aimed to describe sexual function among pessary users and pessary management with regard to sexual activity., Methods: This is a secondary analysis of a randomized trial of new pessary users, where study patients completed validated questionnaires on sexual function and body image at pessary fitting and 3 months later., Main Outcome Measures: Women completed the Pelvic Organ Prolapse-Urinary Incontinence Sexual Function Questionnaire, International Urogynecological Association Revised (PISQ-IR), a validated measure that evaluates the impact of pelvic floor disorders on sexual function, a modified female body image scale (mBIS), and questions regarding pessary management surrounding sexual activity., Results: Of 127 women, 54% (68/127) were sexually active at baseline and 42% (64/114) were sexually active at 3 months. Sexual function scores were not different between baseline and 3 months on all domains except for a drop of 0.15 points (P = 0.04) for sexually active women, and a drop of 0.34 points for non-sexually active women (P = 0.02) in the score related to the sexual partner. Total mBIS score did not change (P = 0.07), but scores improved by 0.2 points (P = 0.03) in the question related to self-consciousness. Pessary satisfaction was associated with improved sexual function scores in multiple domains and improved mBIS scores. The majority (45/64, 70%) of sexually active women removed their pessary for sex, with over half stating their partner preferred removal for sex (24/45, 53%)., Conclusion: Many women remove their pessary during sex for partner considerations, and increased partner concerns are the only change seen in sexual function in the first 3 months of pessary use. Pessary use may improve self-consciousness and pessary satisfaction is associated with improvements in sexual function and body image., (© 2015 International Society for Sexual Medicine.)

Objective: To estimate whether women who underwent mnemonic counseling had better recall of fecal incontinence therapies at 2 months and if mnemonic counseling resulted in greater satisfaction with physician counseling and improvement in quality of life when compared with a group who underwent standard counseling., Methods: Counseling-naive women with fecal incontinence were recruited from an academic urogynecology clinic. Women underwent physical examinations, completed the Quality of the Physician-Patient Interaction, recorded fecal incontinence treatment options they recalled, and completed the Fecal Incontinence Severity Index and Manchester Health Questionnaire immediately after counseling and again at 2 months., Results: Ninety women consented to participate, were randomized, and completed baseline questionnaires. At baseline, women did not differ in age, ethnicity, education, Fecal Incontinence Severity Index, or Manchester Health Questionnaire scores. After counseling, the mnemonic group reported higher satisfaction on Quality of the Physician-Patient Interaction (66.4±6.5 compared with 62.2±10.7, P=.03). Ninety percent (81/90) of women followed up at 2 months. Our primary endpoint, 2-month recall of fecal incontinence treatments, was not different between groups (2.3±1.6 mnemonic counseling compared with 1.8±1.0 standard counseling; P=.08). Secondary endpoints for the mnemonic group reported greater improvement on total Manchester Health Questionnaire (P=.02), emotional (P=.03), sleep (0.045), role limitations (P<.01), and physical limitations (P=.04) when compared with the standard group., Conclusion: Fecal incontinence counseling with a mnemonic aid did not improve recall at 2 months but improved patient satisfaction and quality of life at 2 months.

Objectives: The objectives of this study are to evaluate urinary incontinence and pelvic organ prolapse knowledge among elder southwestern American Indian women and to assess barriers to care for pelvic floor disorders through community-engaged research., Methods: Our group was invited to provide an educational talk on urinary incontinence and pelvic organ prolapse at an annual meeting of American Indian elders. Female attendees aged 55 years or older anonymously completed demographic information and 2 validated questionnaires, the Prolapse and Incontinence Knowledge Questionnaire (PIKQ) and Barriers to Incontinence Care Seeking Questionnaire (BICS-Q). Questionnaire results were compared with historical controls from the original PIKQ and BICS-Q validation study., Results: One hundred forty-four women completed the questionnaires. The mean age was 77.7 ± 9.1 years. The mean (SD) for PIKQ of urinary incontinence score was 6.6 (3.0) (similar to historic gynecology controls 6.8 [3.3], P = 0.49), and the mean (SD) for PIKQ on pelvic organ prolapse score was 5.4 (2.9) (better than historic gynecology controls 3.6 [3.2], P < 0.01). Barriers to care seeking reported by the elder women were highest on the BICS-Q subscales of "cost" and "inconvenience.", Conclusions: Urinary incontinence knowledge is similar to historic gynecology controls, and pelvic organ prolapse knowledge is higher than historic gynecology controls among elder southwestern American Indian women. American Indian elder women report high levels of barriers to care. The greatest barriers to care seeking for this population were related to cost and inconvenience, reflecting the importance of assessing socioeconomic status when investigating barriers to care. Addressing these barriers may enhance care-seeking southwestern American Indian women.