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Female patients with chronic pelvic pain (CPP) face complicated healthcare journeys, but narrative perspectives on CPP treatment are lacking.We collected data in English and Spanish from discussion groups and individual interviews with stakeholders around female CPP.A tertiary care center for gynecologic care.Patients with CPP who self-identified as women/female, community health workers (CHWs), and providers who care for women with CPP.We conducted discussion groups with all 3 types of stakeholders and and individual interviews with female patients who have CPP.Patient participants completed condition specific validated questionnaires. De-identified transcripts were coded with NVivo software. We contrasted patient characteristics and codes between CPP patients that 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 14/47 (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 prior to 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.These findings amongst female patients with CPP and also amongst CHWs and providers advocate for a move toward patient-centered care, particularly the acknowledgement that every woman experiences pain in a singular way. Furthermore, stakeholders voice a deep need for development of individualized treatment plans.

Many health care providers place concomitant midurethral slings during pelvic organ prolapse repair, yet growing evidence supports staged midurethral sling placement.The aim of this study was to compare urinary function after transvaginal uterovaginal prolapse repair with and without midurethral sling.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).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%, P0.001) 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.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.

Introduction: We aimed describe the association of adverse childhood events (ACEs) with a history of substance use disorder and recent opioid use among women with chronic pelvic pain (CPP). Methods: This cohort study investigated two data sets of women presenting to subspecialty gynecologic and pelvic floor disorder clinics where questionnaires querying substance use disorder, opioid use in the last 3 months, and ACEs (BRFSS-ACE questionnaire) were obtained. We compared the recent opioid use, morphine milligram equivalents (MMEs) per dose, pills used per month, and minimum MMEs reported per month between women with high (⩾4) or low (Results: Patients completing the BRFSS-ACE ( n = 113) were older, more likely to be Hispanic/Latina, had higher levels of education, a higher prevalence of pain syndromes, and a greater degree of bother from pelvic floor disorders than those not completing the BRFSS-ACE. Women reporting a high number of (⩾4) ACEs ( n = 56) were younger, less likely to identify as Hispanic, had higher co-occurrence of fibromyalgia and IBS, and a higher prevalence of a history of substance use disorder (18% vs 2%, p Conclusion: Women with CPP reporting higher numbers of ACEs are more likely to report a history of substance use disorder but were not more likely to have used opioids in the last 3 months.

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.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.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.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).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.

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.

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.

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 midsagittal” 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.

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.

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 =

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.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.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, P0.01) and insurance status (P0.01), 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).Chronic pain diagnoses increased risk of midurethral sling revision/removal; pelvic pain and numbers of diagnoses increased this risk.

OBJECTIVES: To (1) evaluate attitudes of resident physicians towards patients with opioid use disorder (OUD) (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, p57; MCRS classification skill on Receiver Operator Curve analysis was excellent [area under curve (AUC) = 0.81 (95% CI 0.74, 0.88), and specialty-adjusted MCRS AUC = 0.85 (95% CI 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.

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.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.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.In the final multivariable model, body mass index (increase of 5 kg/mObesity 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.

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.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.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.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.

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.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.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 of1.5 for the upper limit of 95% confidence interval) between groups for the primary outcome.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).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.

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. 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. 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). 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. ClinicalTrials.gov , www.clinicaltrials.gov , NCT02891187.

The urogenital microbiome is associated with urgency and mixed urinary incontinence symptoms and differential treatment responses to pharmacotherapy for urgency urinary incontinence.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.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.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).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.

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

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.

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.

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.

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. 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

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 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.

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.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.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, P0.001), and specifically more stress UI (73% vs 47%, P0.001). 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.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.

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.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.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).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.

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.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.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.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).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.

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. 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). 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. These findings contribute to a more nuanced understanding of patient-centered perspectives on AEs. Patients view poor functional outcomes as severe AEs.

Introduction and hypothesisWe 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.MethodsThis 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.ResultsSpecimen collection commenced January 2015 and finished April 2016. DNA was extracted and stored for subsequent evaluation.ConclusionsMethods 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.

We sought to identify clinical and demographic characteristics associated with treatment response and satisfaction in women undergoing onabotulinumtoxinA and sacral neuromodulation therapies.We analyzed data from the ROSETTA (Refractory Overactive Bladder: Sacral NEuromodulation versus BoTulinum Toxin Assessment) trial. Baseline participant characteristics and clinical variables were associated with 2 definitions of treatment response, including 1) a reduction in mean daily urgency incontinence episodes during 6 months and 2) a 50% or greater decrease in urgency incontinence episodes across 6 months. The OAB-S (Overactive Bladder-Satisfaction) questionnaire was used to assess satisfaction.A greater reduction in mean daily urgency incontinence episodes was associated with higher HUI-3 (Health Utility Index-3) scores in the onabotulinumtoxinA group and higher baseline incontinence episodes (each p0.001) in the 2 groups. Increased age was associated with a lesser decrease in incontinence episodes in the 2 groups (p0.001). Increasing body mass index (adjusted OR 0.82/5 points, 95% CI 0.70-0.96) was associated with reduced achievement of a 50% or greater decrease in incontinence episodes after each treatment. Greater age (adjusted OR 0.44/10 years, 95% CI 0.30-0.65) and a higher functional comorbidity index (adjusted OR 0.84/1 point, 95% CI 0.71-0.99) were associated with reduced achievement of a 50% or greater decrease in urgency incontinence episodes in the onabotulinumtoxinA group only (p0.001 and 0.041, respectively). In the onabotulinumtoxinA group increased satisfaction was noted with higher HUI-3 score (p = 0.002) but there was less satisfaction with higher age (p = 0.001).Older women with multiple comorbidities, and decreased functional and health related quality of life had decreased treatment response and satisfaction with onabotulinumtoxinA compared to sacral neuromodulation for refractory urgency incontinence.

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.To evaluate hypnotherapy's efficacy compared to medications in treating women with urgency urinary incontinence.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 (P0.025) (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).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%).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.

Introduction & hypothesisPrevious 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.MethodsThis 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 ≥ 51years. Sample size estimates required 200 samples to detect a 20% difference in Lactobacillus predominance with P

Introduction Chronic pelvic pain (CPP) affects an estimated 30% of women Veterans. Previous research shows high rates of narcotic abuse in the women Veteran population. Narcotics are not recommended for the treatment of CPP. Understanding how CPP impacts narcotic prescribing in the women Veteran population is critical to addressing the public health crisis of opioid abuse. Our objective was to compare chronic opioid therapy (COT) prescribed 5 yr prior to and following CPP diagnosis and to identify predictors of COT as well as adverse events associated with COT. We choose to look at 10 yr of data because we thought this time period would provide unique insight into the longitudinal associations of CPP and COT and was available in the database. Materials and Methods Women with non-cancer CPP were included for analyses from the Veteran's Affairs Corporate Database Warehouse. COT was defined as 90 d of opiates/calendar year for each of the 5 yr proceeding and following the diagnosis of CPP. Patient characteristics and potential variables influencing COT were collected. We compared baseline demographics between the women who received COT to the women who did not receive COT to find additional demographic predictors of COT in association with CPP. Multivariable analysis identified predictors of COT in this population of women with CPP. We utilized an interrupted time series analysis to understand the impact of the diagnosis of CPP on COT. Results A total of 49,601 women met inclusion criteria with an average age of 40.1 ± 11.5 yr; 37.3% self-characterized as being a racial minority and 24% had a history of military sexual trauma. Chronic use increased significantly (p < 0.001) in the 5 yr preceding the diagnosis of CPP from 6.3% (n = 3124) of women at time -5 to 13.6% (n = 6746) at time 0. In the first year following the diagnosis of CPP, 16.8% (n = 8,333) of women with CPP met the criteria for COT (p < 0.001) and 15% (n = 7440) of women with CPP remained in the COT group for the remaining 5 yr following the diagnosis. On average women in the COT group had 250-292 d of opioids/year. When comparing women who received chronic narcotics following the diagnosis of CPP versus those who did not receive chronic narcotics, women who received COT were older, more likely to smoke and more frequently diagnosed with other pain conditions such as back pain, headaches, and fibromyalgia. (All p < 0.001). In the multivariable model, predictors of COT following CPP diagnosis included prior COT (OR = 10.0 (95% CI 9.4, 10.6), a positive history of military sexual trauma, smoking, and other chronic pain conditions. Conclusions The distinct pattern of prescribing shown in this cohort may mean COT is prescribed for CPP and this prescribing pattern contributes to the adverse events associated with COT. As COT is not recommended for CPP, physicians need more education on the therapies available to help CPP patients.

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. 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. 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). 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.

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 χ2 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 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.

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.To compare UUI episodes (UUIE) over 24 mo following SNM or BTX.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.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.Primary outcome: change in mean daily UUIE over 24 mo.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.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; p0.001), treatment endorsement (mean difference=-12.16, 95% CI=-17.7--6.63; p0.001) through 24 mo. Other secondary measures did not differ. Recurrent urinary tract infections (UTIs) were higher after BTX (24% vs 10%; p0.01), 6% required intermittent catheterization post second injection. SNM revision and removals occurred in 3% and 9% patients, respectively.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.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.

Women with refractory urgency urinary incontinence (ie, unresponsive to behavioral and pharmacological interventions) are treated with onabotulinumtoxinA or sacral neuromodulation.The objective of the study was to compare treatment efficacy and adverse events in women65 and ≥65 years old treated with onabotulinumtoxinA or sacral neuromodulation.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.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, women65 years had 3.3-fold greater odds of ≥75% resolution than women ≥65 years (95% confidence interval, 1.56 -7.02). Women65 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.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.

To compare fecal incontinence (FI) and urinary incontinence (UI) disclosure in women with dual incontinence (DI), and to assess UI disclosure in DI subjects compared with women with UI alone. We hypothesized that women with DI would be less likely to disclose FI in comparison to UI and as likely to disclose UI as women with UI alone.We performed a retrospective chart review of new patient visits to an academic urogynecology clinic from 2007 to 2011. Clinical records were reviewed; demographic data and responses to the Incontinence Severity Index (ISI) and Wexner scales were recorded. Patients' written responses to the ISI and Wexner were compared with the diagnoses obtained from the oral history by the physician.Of 1,899 women in the database, 557 women were diagnosed with DI and 447 women were diagnosed with UI alone. Women with DI were less likely to orally disclose FI than UI (135 out of 557 [23 %], vs 485 out of 557 [87 %], p 0.001), but were as likely as women with UI alone to disclose UI (385 out of 447 [86 %] vs 485 out of 557 [87 %], p = 0.66). In the multivariate analysis, DI subjects had greater odds of disclosing FI to their physicians if they had private insurance (OR 1.9, 95 %CI 1.2, 3.0) or Wexner score7 (OR 9.0, 95 % CI 5.4,14.8) and lower ISI score (OR 1.5, CI 1.4, 1.6).Women with DI were less likely to report FI in comparison to UI. Patients were more likely to orally report FI when the symptoms were severe.

Using qualitative methods, we compared physician-recommended treatment options for fecal incontinence to patient knowledge of treatment options. Our hypothesis was that physician recommendations were not being communicated well to patients and that this impaired patients’ ability to cope with fecal incontinence. Cognitive interviews were conducted with physicians who routinely care for women with fecal incontinence. Physicians were asked to describe their typical nonsurgical treatment recommendations and counseling for fecal incontinence. Women with bothersome fecal incontinence were recruited to participate in focus groups and asked about personal experience with fecal incontinence symptoms and treatment options. For both physician interviews and patient focus groups, qualitative data analysis was performed using grounded-theory methodology. Physicians identified several barriers patients face when seeking treatment: lack of physician interest toward fecal incontinence, and patient embarrassment in discussing fecal incontinence. Physicians universally recommended fiber and pelvic floor exercise; they felt the majority (approximately 70–80 %) of patients will improve with these therapies. Collectively, patients were able to identify all treatment recommendations given by physicians, although many had discovered these treatments through personal experience. Three concepts emerged regarding treatment options that physicians did not identify but that patients felt were important in their treatment: hope for improvement, personal effort to control symptoms, and encouragement to go on living life fully. Whereas physicians had treatment to offer women with fecal incontinence, women had already found the best treatments through personal research and effort. Women want to hear a message of hope and encouragement and perceive personal effort from providers.