Randomized Trial on Expectations and Pain Control Advancement in Surgery: The REPAIR Study.

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.

Centering Group Treatment for Women With Interstitial Cystitis/Bladder Pain Syndrome: A Prospective, Parallel-Group Cohort Study.

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.

Intraoperative Predictors of Sacral Neuromodulation Implantation and Treatment Response: Results From the ROSETTA Trial.

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.

Beliefs and Narratives Associated with the Treatment of Chronic Pelvic Pain in Women.

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.

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

BACKGROUND: Among women with symptomatic uterovaginal prolapse undergoing vaginal surgery in the Vaginal hysterectomy with Native Tissue Vault Suspension vs Sacrospinous Hysteropexy with Graft Suspension (Study for Uterine Prolapse Procedures Randomized Trial) trial, sacrospinous hysteropexy with graft (hysteropexy) resulted in a lower composite surgical failure rate than vaginal hysterectomy with uterosacral suspension over 5 years. OBJECTIVE: This study aimed to identify factors associated with the rate of surgical failure over 5 years among women undergoing sacrospinous hysteropexy with graft vs vaginal hysterectomy with uterosacral suspension for uterovaginal prolapse. STUDY DESIGN: This planned secondary analysis of a comparative effectiveness trial of 2 transvaginal apical suspensions (NCT01802281) defined surgical failure as either retreatment of prolapse, recurrence of prolapse beyond the hymen, or bothersome prolapse symptoms. Baseline clinical and sociodemographic factors for eligible participants receiving the randomized surgery (N=173) were compared across categories of failure (≤1 year, >1 year, and no failure) with rank-based tests. Factors with adequate prevalence and clinical relevance were assessed for minimally adjusted bivariate associations using piecewise exponential survival models adjusting for randomized apical repair and clinical site. The multivariable model included factors with bivariate P<.2, additional clinically important variables, apical repair, and clinical site. Backward selection determined final retained risk factors (P<.1) with statistical significance evaluated by Bonferroni correction (P<.005). Final factors were assessed for interaction with type of apical repair at P<.1. Association is presented by adjusted hazard ratios and further illustrated by categorization of risk factors. RESULTS: In the final multivariable model, body mass index (increase of 5 kg/m2: adjusted hazard ratio, 1.7; 95% confidence interval, 1.3-2.2; P<.001) and duration of prolapse symptoms (increase of 1 year: adjusted hazard ratio, 1.1; 95% confidence interval, 1.0-1.1; P<.005) were associated with composite surgical failure, where rates of failure were 2.9 and 1.8 times higher in women with obesity and women who are overweight than women who have normal weight and women who are underweight (95% confidence intervals, 1.5-5.8 and 0.9-3.5) and 3.0 times higher in women experiencing >5 years prolapse symptoms than women experiencing ≤5 years prolapse symptoms (95% confidence interval, 1.8-5.0). Sacrospinous hysteropexy with graft had a lower rate of failure than hysterectomy with uterosacral suspension (adjusted hazard ratio, 0.6; 95% confidence interval, 0.4-1.0; P=.05). The interaction between symptom duration and apical repair (P=.07) indicated that failure was less likely after hysteropexy than hysterectomy for those with ≤5 years symptom duration (adjusted hazard ratio, 0.5; 95% confidence interval, 0.2-0.9), but not for those with >5 years symptom duration (adjusted hazard ratio, 1.0; 95% confidence interval 0.5-2.1). CONCLUSION: Obesity and duration of prolapse symptoms have been determined as risk factors associated with surgical failure over 5 years from transvaginal prolapse repair, regardless of approach. Providers and patients should consider these modifiable risk factors when discussing treatment plans for bothersome prolapse.

Centering Group Treatment for Women With Interstitial Cystitis/Bladder Pain Syndrome: A Qualitative Analysis.

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.

Long-term Urinary Outcomes After Transvaginal Uterovaginal Prolapse Repair With and Without Concomitant Midurethral Slings.

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.

Alignment Between Resident Medical Condition Regard Scale Scores and Desire to Treat Patients With Opioid Use Disorder.

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.

Midurethral Sling Removal or Revision in Women with Chronic Pain.

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.

Chlorhexidine gluconate vs povidone-iodine vaginal antisepsis for urogynecologic surgery: a randomized controlled noninferiority trial.

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.

Association between the urogenital microbiome and surgical treatment response in women undergoing midurethral sling operation for mixed urinary incontinence.

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.

Preferences for Preoperative Education: A Qualitative Study of the Patient Perspective.

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.

Defining mechanisms of recurrence following apical prolapse repair based on imaging criteria.

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.

Adverse Childhood Experiences in Women With Overactive Bladder or Interstitial Cystitis/Bladder Pain Syndrome.

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.

Perineorrhaphy Outcomes Related to Body Imagery: A Randomized Trial of Body Image Perception.

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.

The Design of a Prospective Trial to Evaluate the Role of Preoperative Frailty Assessment in Older Women Undergoing Surgery for the Treatment of Pelvic Organ Prolapse: The FASt Supplemental Trial.

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.

Methods for the defining mechanisms of anterior vaginal wall descent (DEMAND) study.

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.

Home Biofeedback Versus Physical Therapy for Stress Urinary Incontinence: A Randomized Trial.

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.

Mind-body (hypnotherapy) treatment of women with urgency urinary incontinence: changes in brain attentional networks.

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.