Background and Objectives:Uterine fibroids are common in women and can lead to symptoms of abnormal uterine bleeding, pelvic pain and bulk symptoms. Treatment can be medical or surgical. This study aims to describe characteristics and outcomes of women undergoing combined laparoscopic radiofrequency ablation (lap-RFA) and laparoscopic myomectomy (lap-MYO) to treat symptomatic uterine fibroids. Methods:This is a multicenter prospective cohort study including both academic centers and private practices. Women in the Uterine Leiomyoma Treatment by Radiofrequency Ablation (ULTRA) Study who were scheduled to undergo surgical management of fibroids underwent a combined lap-RFA and lap-MYO. We assessed quality of life and sexual function changes from before to 12 months after surgery using validated questionnaires. Results:Of the 480 participants in ULTRA, 49 underwent a combined lap-RFA and lap-MYO procedure between 2014 and 2022. The mean number of fibroids treated was 3.6 (standard deviation [SD] 2.0). The mean number of days to return to usual activities was 12.7 (SD 10.1). The Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire symptom severity score (0-100 points) improved by 36.4 points (SD 27.0, P < .001) at 12 months and the Sexual Health Outcomes in Women Questionnaire (0-100 points) assessment of pelvic problems interference with sex improved by 13 points (SD 34.4 P = .02) as early as 6 weeks. About 75% of women were satisfied with the surgery at 12 months. Conclusion:Combining lap-RFA and lap-MYO is associated with few peri-operative events, satisfactory recovery time, and significant improvement in quality-of-life measures with high patient satisfaction through 12 months after surgery.

Nocturia (i.e., waking to void during the primary sleep period) of two or more times per night affects nearly one-third of older adults and can have a severe impact on sleep, contributing to insomnia symptoms. Current treatment approaches for nocturia often overlook non-lower urinary tract factors that may contribute to nighttime awakenings. Nocturia management, for example, may benefit from more effective integration of cognitive behavioral therapy for insomnia (CBT-I) principles that address other factors underlying insomnia symptoms, and early evidence suggests it also reduces nocturia and the bother it causes. Because nocturia treatment crosses specialties, coordinated delivery of urological and sleep therapies is a treatment barrier. The overall purpose of this trial is to determine whether a promising coordinated, integrated behavioral, non-pharmacological, non-surgical treatment that simultaneously addresses both the urological and insomnia factors contributing to nocturia is efficacious for improving nocturia, sleep, and daytime function. This multicenter parallel-group randomized, efficacy trial compares a 5-week integrated behavioral treatment program delivered by a single interventionist (psychologist, nurse practitioner, or physician assistant) to a health education control program in adults aged 60 years or older (proposed n = 192) recruited from sites in Atlanta and Los Angeles, who report typically getting up to urinate two or more times per night (International Consultation on Incontinence Questionnaire-Overactive bladder [ICIQ-OAB] nocturia item) and insomnia symptoms (Insomnia Severity Index > 7). The integrated program includes components of CBT-I and pelvic floor muscle exercise-based behavioral therapy for nocturia. The primary outcome is ICIQ-OAB-measured nocturia frequency 4 months after randomization. Secondary outcomes are sleep diary-measured wake after sleep onset (mean minutes) and Insomnia Severity Index total score. The interdisciplinary trial team has developed a program aimed at improving nocturia symptoms and overall sleep of older adults in an efficient and safe manner. The integrated behavioral program has the potential to address nocturia, which is a challenging symptom because it has many etiologies that cross multiple specialties. Findings will provide rigorous evidence of the efficacy of the integrated behavioral treatment program to reduce nocturia frequency as well as sleep disturbance in older adults. Clinicaltrials.gov NCT06110091, registered 10/25/2023.

Neighborhood factors, encompassing social, built, and natural environments, may explain geographic differences in the impact of COVID-19 pandemic on populations. Data from pre-existing national, population-based cohorts could be leveraged to better understand how pre-existing conditions (both individual and neighborhood) contribute to risk factor development and disease progression. We catalogued spatial and neighborhood data in the Collaborative Cohort of Cohorts for COVID-19 Research (C4R), comprising 14 diverse US cohorts (>50,000 participants). The C4R sample is generally spatially and socially representative of the overall nation, with C4R's calculated spatial coverage representing 28% of US land area and 52% of the total US population. However, C4R (vs. non C4R) areas were more urban, wealthy, with more foreign-born residents, and less car-dependent with lower proportion employed and green. Twelve cohorts collected neighborhood characteristics - most commonly social environment data on neighborhood socioeconomic status- based on participants' addresses. The most common built environment measures were related to food access, followed by other destination-based measures such as walkability. Natural environment data were available in the fewest cohorts, with emphasis on air quality or greenspace. This work provides clarity on available neighborhood and spatial data and facilitates future harmonization of data from C4R cohorts. Ultimately, this may enable future longitudinal and comparative analyses of neighborhood influences on COVID-19.

IMPORTANCE:Urinary incontinence (UI) can negatively affect sexual function in women. Although many women with UI seek complementary strategies such as pelvic floor yoga techniques to improve sexual functioning, evidence of their efficacy is limited. OBJECTIVE:The objective of this study was to evaluate the effects of a pelvic floor yoga program versus a general physical conditioning program on multidimensional sexual function in women with UI. STUDY DESIGN:Ambulatory women aged 45 and older with daily UI were enrolled in a multicenter randomized trial in 2019-2022. Participants were randomized to a 12-week program of group instruction and self-practice of Hatha yoga techniques tailored to pelvic floor function (pelvic yoga) or a time-equivalent program of general skeletal muscle exercises (physical conditioning). Intervention effects on sexual function, a prespecified secondary trial outcome, were examined using linear mixed models of change in Pelvic Organ Prolapse/Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR) scores over 6 and 12 weeks of intervention instruction. RESULTS:Among 240 participants (121 pelvic yoga, 119 physical conditioning; ages 45-90 years), UI frequency averaged 3.4±2.2 episodes/day, and 129 (54.7%) participants were sexually active at baseline. Compared with physical conditioning, pelvic yoga did not result in significantly greater improvements in any PISQ-IR domain over 6 and 12 weeks. Within-group analyses showed that sexually active participants in the yoga group had a 3.7 (95% CI: 1.4-6.1) point improvement in condition-specific impact on sexual activity. CONCLUSIONS:Among midlife and older women with daily UI, a 12-week pelvic yoga intervention did not result in meaningfully greater improvements in sexual function compared with nonspecific physical conditioning exercise.

OBJECTIVE:To evaluate prospective changes in psychological function among menopausal women using continuous nitroglycerin for hot flashes and examine repeated associations between psychological symptoms and hot flashes. METHODS:Menopausal women with ≥7 hot flashes/day were randomized to continuous transdermal nitroglycerin (0.2-0.4 mg/h) or placebo for 12 weeks. Psychological function was evaluated using the Center for Epidemiologic Studies-Depression Scale (CES-D), Generalized Anxiety Disorders-7 (GAD-7), and Menopause-Specific Quality of Life (MENQOL) Psychosocial Subscale. Linear mixed models examined treatment effects on mood symptoms from baseline to 5 and 12 weeks. Based on validated 7-day hot flash diaries, additional models examined associations between mood symptoms and hot flash frequency in both groups combined. RESULTS:Among the 141 randomized participants (mean 10.8±3.5 hot flashes/day), nitroglycerin therapy did not improve CES-D or GAD-7 scores (prespecified secondary outcomes) from baseline to 5 and 12 weeks compared with placebo. Greater hot flash frequency was associated with worse GAD-7 scores across all timepoints (β=0.05 per 1 hot flash, P =0.005), but no associations between hot flashes and CES-D or MENQOL Psychosocial scores were observed. Improvement in hot flash frequency was associated with improvement in MENQOL Psychosocial score (β=0.04 per 1 hot flash, P =0.03), but no associations between improvements in hot flashes and improvements in GAD-7 or CES-D scores were detected. CONCLUSIONS:In a randomized trial of continuous nitroglycerin, improvements in hot flash frequency did not consistently translate into improvements in mood. Clinicians caring for women with overlapping hot flashes and mood symptoms should consider other factors influencing midlife psychological function.

Introduction and HypothesisUterine leiomyomata are widely believed to contribute to lower urinary tract symptoms in women, but it is unclear whether leiomyoma size, position, and location have important implications for these symptoms. We assessed whether greater leiomyoma volume, anterior position, and subserosal location were associated with urinary incontinence and frequent urination in a racially diverse, nationwide sample of premenopausal women in the USA.MethodsA cross-sectional analysis of 477 premenopausal women from 12 USA sites undergoing evaluation for laparoscopic radiofrequency ablation or myomectomy for leiomyomata was carried out. Multivariable logistic regression models examined associations between leiomyoma volume, position, and location documented in clinical imaging reports and participant-reported urinary incontinence and distressing urination frequency, adjusting for age, race, parity, and body mass index.ResultsAmong the 477 participants, 27.9% reported at least weekly incontinence, 72.8% distressing daytime urination frequency, and 63.4% frequent night-time urination. Greater total leiomyoma volume was associated with at least weekly incontinence of any type (OR 1.05, 95% CI 1.02-1.07, per 20-ml increase) and at least weekly stress-predominant incontinence (OR 1.04, 95% CI 1.01-1.07, per 20-ml increase), but not distressing daytime or night-time urination frequency. Although subserosal leiomyoma position was associated with a 2.01-fold (95% CI 1.14-3.56) greater odds of frequent night-time urination, no significant associations between leiomyomata location or position and incontinence were detected.ConclusionIn this multicenter sample of women seeking treatment for symptomatic leiomyomata, greater leiomyomata volume was associated with weekly any-type and stress-type incontinence, but leiomyoma position and location were not independently associated with urinary incontinence.

Yoga, an integrative health practice combining movement and mindfulness, has been recommended to improve sleep in adults with chronic conditions, but it is unclear whether it offers unique benefits for sleep compared with nonspecific exercise. To compare the effects of a yoga intervention vs a nonspecific physical conditioning intervention on sleep outcomes in women with urinary incontinence. This prespecified secondary analysis of a multicenter, investigator-blinded randomized clinical trial was conducted from 2018 to 2022, with 3 months of intervention follow-up, at 3 sites in Northern California. Interventions were delivered in person and via videoconference after the start of the COVID-19 pandemic. Women aged 45 to 90 years with daily incontinence were included. Data were analyzed from June to September 2024. Random assignment to a 3-month yoga intervention involving twice-weekly instruction and once-weekly self-directed practice of hatha yoga techniques vs a time-equivalent physical conditioning intervention. Sleep quality and disruption were assessed using the Pittsburgh Sleep Quality Index (PSQI) and Pittsburgh Sleep Diary. Nocturnal incontinence and voiding frequency were evaluated using voiding diaries. Among 240 participants (mean [SD] age, 62.0 [8.7] years; 40 Asian [21.1%], 19 Black [7.9%], 160 White [66.7%], and 20 >1 race [8.3%]; 32 Latina [13.3%]), 133 participants (55.4%) reported poor sleep quality (PSQI >5) and 133 of 239 participants with data (55.7%) reported awakening at least once per night to use the bathroom at baseline. The mean change in PSQI score over 3 months was 0.37 points (95% CI, 0.78 to −0.04 points) in the yoga group, vs 0.66 points (95% CI, 1.07 to 0.25 points) in the physical conditioning group (between-group difference: 0.29 points [95% CI −0.28 to 0.86 points]). The mean change in wakefulness after sleep onset was 3.82 minutes (95% CI, 8.15 to −0.52 minutes) in the yoga group, and 6.97 minutes (95% CI, 11.20 to 2.74 minutes) in the physical conditioning group (between-group difference, 3.16 minutes [95% CI, −2.84 to 9.16 minutes]). Across all participants regardless of intervention, greater nocturnal voiding frequency was associated with worse sleep quality; for example, the estimated mean PSQI score was 5.83 points (95% CI, 5.35 to 6.32 points) among participants with fewer than 1 nocturnal voiding episode per night but 6.66 points (95% CI, 6.00 to 7.33 points) among those with at least 2 episodes per night ( P = .02 for linear trend across increasing categories of nocturnal voiding frequency). In this study, a 3-month yoga intervention did not yield superior outcomes for sleep quality or disruption compared with a general physical conditioning intervention among women with incontinence. Ancillary Study of the Lessening Incontinence With Low-Impact Activity Study, ClinicalTrials.gov Identifier: NCT04776720 ; A Group-Based Therapeutic Yoga Intervention for Urinary Incontinence in Ambulatory Older Women, ClinicalTrials.gov Identifier: NCT03672461

Importance:Yoga, an integrative health practice combining movement and mindfulness, has been recommended to improve sleep in adults with chronic conditions, but it is unclear whether it offers unique benefits for sleep compared with nonspecific exercise. Objective:To compare the effects of a yoga intervention vs a nonspecific physical conditioning intervention on sleep outcomes in women with urinary incontinence. Design, Setting, and Participants:This prespecified secondary analysis of a multicenter, investigator-blinded randomized clinical trial was conducted from 2018 to 2022, with 3 months of intervention follow-up, at 3 sites in Northern California. Interventions were delivered in person and via videoconference after the start of the COVID-19 pandemic. Women aged 45 to 90 years with daily incontinence were included. Data were analyzed from June to September 2024. Interventions:Random assignment to a 3-month yoga intervention involving twice-weekly instruction and once-weekly self-directed practice of hatha yoga techniques vs a time-equivalent physical conditioning intervention. Main Outcomes and Measures:Sleep quality and disruption were assessed using the Pittsburgh Sleep Quality Index (PSQI) and Pittsburgh Sleep Diary. Nocturnal incontinence and voiding frequency were evaluated using voiding diaries. Results:Among 240 participants (mean [SD] age, 62.0 [8.7] years; 40 Asian [21.1%], 19 Black [7.9%], 160 White [66.7%], and 20 >1 race [8.3%]; 32 Latina [13.3%]), 133 participants (55.4%) reported poor sleep quality (PSQI >5) and 133 of 239 participants with data (55.7%) reported awakening at least once per night to use the bathroom at baseline. The mean change in PSQI score over 3 months was 0.37 points (95% CI, 0.78 to -0.04 points) in the yoga group, vs 0.66 points (95% CI, 1.07 to 0.25 points) in the physical conditioning group (between-group difference: 0.29 points [95% CI -0.28 to 0.86 points]). The mean change in wakefulness after sleep onset was 3.82 minutes (95% CI, 8.15 to -0.52 minutes) in the yoga group, and 6.97 minutes (95% CI, 11.20 to 2.74 minutes) in the physical conditioning group (between-group difference, 3.16 minutes [95% CI, -2.84 to 9.16 minutes]). Across all participants regardless of intervention, greater nocturnal voiding frequency was associated with worse sleep quality; for example, the estimated mean PSQI score was 5.83 points (95% CI, 5.35 to 6.32 points) among participants with fewer than 1 nocturnal voiding episode per night but 6.66 points (95% CI, 6.00 to 7.33 points) among those with at least 2 episodes per night (P = .02 for linear trend across increasing categories of nocturnal voiding frequency). Conclusions and Relevance:In this study, a 3-month yoga intervention did not yield superior outcomes for sleep quality or disruption compared with a general physical conditioning intervention among women with incontinence. Trial Registration:Ancillary Study of the Lessening Incontinence With Low-Impact Activity Study, ClinicalTrials.gov Identifier: NCT04776720; A Group-Based Therapeutic Yoga Intervention for Urinary Incontinence in Ambulatory Older Women, ClinicalTrials.gov Identifier: NCT03672461.

BACKGROUND:Hot flashes, common during menopause, affect up to 80% of the Western menopausal women and are reported to contribute to sleep disturbances in midlife. Few prospective data are available to confirm the specific role of hot flashes in disrupting sleep in midlife women, however, or confirm whether changes in hot flashes in response to clinical therapies result in improvement in sleep. OBJECTIVE:To examine the effects of continuous nitroglycerin therapy on sleep quality in perimenopausal and postmenopausal women with frequent hot flashes (pre-specified secondary trial endpoint) and to examine prospective associations between hot flashes and sleep disruption in this population. STUDY DESIGN:Sleep data were analyzed from a randomized, double-blinded, placebo-controlled trial of continuous transdermal nitroglycerin (NTG) therapy to suppress nitric oxide-mediated vasodilation in perimenopausal or postmenopausal women with hot flashes. Participants were randomized to uninterrupted use of transdermal NTG (0.2-0.6 mg/hour) or placebo for 12 weeks. Nocturnal hot flashes awakening participants from sleep were evaluated using 7-day symptom diaries at baseline, 5 weeks, and 12 weeks. Sleep disruption (wakefulness after sleep onset, WASO) was assessed using validated sleep diaries, and global sleep quality was assessed by the validated Pittsburgh Sleep Quality Index (PSQI: range 0 [best] 21 [worst]) questionnaire. Mixed linear models examined changes in sleep quality and disruption, as well as the strength of associations between nocturnal hot flash frequency and sleep outcomes, over 5 and 12 weeks, adjusting for baseline values, age, race, and ethnicity. RESULTS:Among the 141 participants (70 to NTG and 71 to placebo, mean age 54.6 [±3.9] years), the mean baseline hot flash frequency was 10.8 (±3.5) per day, including 2.6 (±1.7) nocturnal hot flashes awakening participants. At baseline, hot flashes were the most commonly reported reason for nocturnal awakening, with 62.6% of participants reporting waking due to hot flashes at least twice nightly. Over 5 and 12 weeks, mean frequency of nocturnal hot flashes causing awakenings decreased in both groups (NTG: -0.9 episodes/night, placebo: -1.0 episodes/night). Sleep disruption as measured by average nightly WASO also decreased (NTG: -10.1 minutes, placebo: -7.3 minutes), and mean PSQI score improved (NTG: -1.3 points, placebo: -1.2 points). No significant between-group differences in change in sleep outcomes were detected from baseline to 5 and 12 weeks, including PSQI sleep quality score as a prespecified secondary trial endpoint (P≥.05 for all). Greater improvement in nocturnal hot flash frequency over 5 and 12 weeks was associated with greater improvement in PSQI sleep quality score (β= -0.30, P=.01) and sleep disruption reflected by WASO (β= -1.88, P=.02) in the combined sample. CONCLUSION:Among menopausal women in a randomized trial of continuous NTG therapy for hot flashes, hot flashes were the most frequently reported cause of nocturnal awakenings. Compared to placebo, continuous NTG therapy did not result in greater improvements in sleep quality from baseline to 5 and 12 weeks. Based on night-by-night symptom diaries and questionnaires, however, greater improvement in nocturnal hot flash frequency in both groups was associated with greater improvement in sleep quality and disruption.

OBJECTIVE: To compare pregnancy outcomes after laparoscopic radiofrequency ablation and myomectomy. METHODS: The ULTRA (Uterine Leiomyoma Treatment With Radiofrequency Ablation) study is an ongoing multicenter prospective cohort study with longitudinal follow-up up to 5 years comparing outcomes of radiofrequency ablation with myomectomy in premenopausal women older than age 21 years with symptomatic uterine leiomyomas. Participants were queried every 6 months after surgery to assess the incidence of pregnancy and pregnancy outcomes. RESULTS: Among 539 women enrolled in ULTRA, a total of 37 participants (mean age at first pregnancy 35.0±4.7 years) conceived 43 times as of March 2023 (22 radiofrequency ablation, 21 myomectomy). The average length of follow-up time after all procedures was 2.5±1.0 years. The baseline miscarriage rate in the study population was 33.3%. In participants who underwent radiofrequency ablation, 9 of 22 pregnancies (40.9%, 95% CI, 20.3–61.5%) ended in first-trimester miscarriage, 11 resulted in live births (50.0%, 95% CI, 29.1–70.9%), one resulted fetal death at 30 weeks of gestation, and one resulted in uterine rupture during miscarriage treatment with misoprostol 10 weeks after radiofrequency ablation. Among the live births in the radiofrequency ablation group, 45.5% were by vaginal delivery. In the myomectomy group, 9 of 21 pregnancies (42.9%, 95% CI, 21.7–64.0%) ended in first-trimester miscarriage and 12 resulted in live births (57.1%, 95% CI, 36.0–78.3%). There were no significant differences in the likelihood of live birth or miscarriage between the study groups. CONCLUSION: Full-term pregnancy and vaginal delivery are achievable after radiofrequency ablation of leiomyomas. However, in this interim analysis, the miscarriage rate in both radiofrequency ablation and myomectomy groups was higher than expected for women in this age group. Long-term data collection in the ongoing ULTRA study aims to further understand pregnancy outcomes after radiofrequency ablation compared with myomectomy. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT0210094.

Objective: Yoga has been recommended as a complementary management strategy for women with chronic pelvic pain (CPP), but many women lack access to specialized yoga instruction for this indication, and few data are available to evaluate changes in CPP with yoga. This feasibility trial evaluated the acceptability and tolerability of a remotely delivered yoga program for CPP in women and examined data quality and interpretability for measures of pelvic pain intensity and impact with yoga instruction. Methods: Ambulatory women with CPP were recruited from northern California in 2020-2022 and randomly assigned to a 2-month program involving twice weekly group classes delivered by videoconference supplemented by individual practice of pelvic yoga techniques versus a control program involving equivalent-time instruction and practice of nonspecific skeletal muscle stretching-strengthening exercises. Diaries, questionnaires, and in-class observations assessed intervention adherence and self-efficacy as well as CPP intensity and impact. Results: Among the 36 participants randomized (aged 27-77 years), the average (±standard deviation) baseline pelvic pain intensity was 4.2 (±2.0) (0-10 scale). Thirty-one (86%) completed the 2-month intervention programs, and 27 (75%) attended more than 85% of intervention classes. Among participants completing the yoga program (N = 16), 14 (87%) reported being at least moderately confident about performing all yoga postures after 2 months. Thirty (83%) provided pain intensity data at 2 months. Average pelvic pain intensity "at its worst" and "on average" were 1.9 (±1.6) and 1.1 (±1.4) points lower, respectively, after 2 months in this yoga group. Yoga participants also reported improvements in scores in the emotional, occupational, and psychological domains of the Impact of Female Chronic Pelvic Pain Questionnaire. Conclusions: Findings demonstrate the feasibility and acceptability of a videoconference-based yoga program and collection of pain-related data among women with CPP, paving the way for future research to rigorously evaluate its specific efficacy in representative samples of women. Clinicaltrials.gov identifier: NCT04615247.

BACKGROUND:Nocturia (waking from sleep at night to void) and chronic insomnia frequently co-exist in older adults, contributing synergistically to sleep disturbance. Treatments typically target either nocturia or insomnia rather than simultaneously addressing shared mechanisms for these disorders. METHODS:We conducted a multisite feasibility study to: (1) test and refine a protocol for recruitment, randomization, and assessment of older adults with co-existing nocturia and insomnia; and (2) examine preliminary changes in outcome measures to inform a future larger, multisite clinical trial. Participants were men and women aged 60 years and older recruited from outpatient clinics, reporting an average of two or more nocturia episodes per night over the past 4 weeks and meeting diagnostic criteria for chronic insomnia disorder. Participants were randomized to receive either integrated cognitive-behavioral therapy for insomnia and nocturia or a health education control program involving five weekly visits with a trained nurse practitioner interventionist. Outcomes (e.g., nocturia episodes) were measured 1-week post-treatment and 4-month post-randomization. Descriptive statistics examined the feasibility of outcomes to guide preparations for a future efficacy trial. RESULTS:Of 245 adults screened, 55% were ineligible and 25% declined to participate. Sixty-one percent of 49 participants who provided informed consent were randomized. Of the 30 participants randomized (mean age = 70.6 years, 60% White), 14 were assigned to integrated cognitive-behavioral treatment and 16 to the control group. All randomized participants provided 4-month follow-up data. At 4 months, mean nightly nocturia episodes decreased by 0.9 (SD 1.0) in the integrated treatment group and by 0.2 (SD 1.2) in the control group compared with baseline. DISCUSSION:Findings demonstrate the feasibility of recruiting, randomizing, and collecting outcome data from older adults (predominantly male) assigned to an integrated cognitive-behavioral therapy for coexisting insomnia and nocturia or a health education control program.

Background: Pelvic floor yoga has been recommended as a complementary treatment strategy for urinary incontinence (UI) in women, but evidence of its efficacy is lacking. Objective: To evaluate the effects of a therapeutic pelvic floor yoga program versus a nonspecific physical conditioning program on UI in women. Design: Randomized trial. (ClinicalTrials.gov: NCT03672461) Setting: Three study sites in California, United States. Participants: Ambulatory women aged 45 years or older reporting daily urgency-, stress-, or mixed-type UI. Intervention: Twelve-week program of twice-weekly group instruction and once-weekly self-directed practice of pelvic floor-specific Hatha yoga techniques (pelvic yoga) versus equivalent-time instruction and practice of general skeletal muscle stretching and strengthening exercises (physical conditioning). Measurements: Total and type-specific UI frequency assessed by 3-day voiding diaries. Results: Among the 240 randomly assigned women (age range, 45 to 90 years), mean baseline UI frequency was 3.4 episodes per day (SD, 2.2), including 1.9 urgency-type episodes per day (SD, 1.9) and 1.4 stress-type episodes per day (SD, 1.7). Over a 12-week time period, total UI frequency (primary outcome) decreased by an average of 2.3 episodes per day with pelvic yoga and 1.9 episodes per day with physical conditioning (between-group difference of -0.3 episodes per day [95% CI, -0.7 to 0.0]). Urgency-type UI frequency decreased by 1.2 episodes per day in the pelvic yoga group and 1.0 episode per day in the physical conditioning group (between-group difference of -0.3 episodes per day [CI, -0.5 to 0.0]). Reductions in stress-type UI frequency did not differ between groups (-0.1 episodes per day [CI, -0.3 to 0.3]). Limitation: No comparison to no treatment or other clinical UI treatments; conversion to videoconference-based intervention instruction during the COVID-19 pandemic. Conclusion: A 12-week pelvic yoga program was not superior to a general muscle stretching and strengthening program in reducing clinically important UI in midlife and older women with daily UI. Primary Funding Source: National Institutes of Health.

Abstract Introduction One in seven women suffer from chronic pelvic pain (CPP), a syndrome associated with decreased sexual desire, decreased enjoyment of sexual activity, and increased conflict with sexual partners. Pelvic yoga has been recommended as a complementary community-based management strategy for CPP, given its potential to address multiple contributors to this complex pain syndrome. However, it is unclear whether pelvic yoga instruction can be delivered in a way that is accessible and acceptable for diverse women with CPP in the community. Objective To evaluate the feasibility of a telehealth-based pelvic yoga program for women with CPP and examine preliminary changes in pain-related sexual and overall functioning with yoga instruction and practice. Methods The Program to Overcome Pelvic Pain studY (POPPY) is a pilot randomized trial of a telehealth-based pelvic yoga program designed by an expert yoga panel to address multiple contributors to CPP in women. From 2020 to 2022, women who reported pelvic pain for at least 6 months and at least 4 out of 10 on a pain severity scale were recruited from multiple communities in northern California and randomly assigned in a 1:1 ratio to the telehealth-based study yoga program or an equivalent-time stretching-strengthening control program. Women in the yoga program participated in twice-weekly group videoconference yoga classes supplemented by weekly individual practice of study-specific Hatha yoga techniques; women in the control group took part in equivalent-time group classes and individual practice of general muscle stretching-strengthening exercises that avoided engaging the pelvic floor. Structured diaries and questionnaires assessed participants’ adherence and self-efficacy in practicing intervention techniques as well as their pain-related functioning after 2 months of intervention instruction and another 2 months of maintenance practice. Results Among 36 women randomized over 3 intervention waves (12 women per wave), mean age was 51 (range 27 to 77) years, 33% self-identified as racial or ethnic minorities, and 81% were married or had sexual partners. Eighty-six percent completed the 2-month intervention programs; of these, 87% completed at least 14 of 16 group telehealth classes. Among women completing yoga instruction, 86% felt it was easier to attend yoga classes by telehealth rather than in person. The yoga intervention was associated with improvements in multiple domains of the validated Impact of Female Chronic Pelvic Pain Questionnaire (IFCPPQ), with mean (SD) scores on the IFCPPQ sexual impact subscale decreasing 12.0 (±25.4) points after 2 months of yoga instruction (P=.15) and 20.0 (±21.2) points after another 2 months of maintenance practice (P=.02). Modest improvements in multiple IFCPPQ domains were also observed in the stretching-strengthening control group, although changes in IFCPPQ sexual impact scores did not reach statistical significance among controls (Table 1). Conclusions Findings demonstrate the feasibility of engaging women with chronic pelvic pain in a telehealth-based pelvic yoga program and provide preliminary evidence of improvement in pelvic pain-related sexual function associated with yoga practice. If yoga can be taught in a way that is appropriate and accessible to diverse women in the community, it may offer a promising complementary management strategy for CPP. Disclosure No

Significant bone loss occurs after risk-reducing salpingo-oophorectomy at age 34–50 years that has the potential to be mitigated by use of hormonal therapy. OBJECTIVE: To evaluate the effect of risk-reducing salpingo-oophorectomy (RRSO) on change in bone mineral density (BMD) in women aged 34–50 years with pathogenic variants in BRCA1 or BRCA2 (BRCA1/2). METHODS: The PROSper (Prospective Research of Outcomes after Salpingo-oophorectomy) study is a prospective cohort of women aged 34–50 years with BRCA1 or two germline pathogenic variants that compares health outcomes after RRSO to a non-RRSO control group with ovarian conservation. Women aged 34–50 years, who were planning either RRSO or ovarian conservation, were enrolled for 3 years of follow-up. Spine and total hip BMD were measured by dual-energy X-ray absorptiometry (DXA) scans obtained at baseline before RRSO or at the time of enrollment for the non-RRSO group, and then at 1 and 3 years of study follow-up. Differences in BMD between the RRSO and non-RRSO groups, as well as the association between hormone use and BMD, were determined by using mixed effects multivariable linear regression models. RESULTS: Of 100 PROSper participants, 91 obtained DXA scans (RRSO group: 40; non-RRSO group: 51). Overall, total spine, and hip BMD decreased significantly from baseline to 12 months after RRSO (estimated percent change −3.78%, 95% CI −6.13% to −1.43% for total spine; −2.96%, 95% CI −4.79% to −1.14% for total hip) and at 36 months (estimated percent change −5.71%, 95% CI −8.64% to −2.77% for total spine; −5.19%, 95% CI −7.50% to −2.87% for total hip. In contrast, total spine and hip BMD were not significantly different from baseline for the non-RRSO group. The differences in mean percent change in BMD from baseline between the RRSO and non-RRSO groups were statistically significant at both 12 and 36 months for spine BMD (12-month difference −4.49%, 95% CI −7.67% to −1.31%; 36-month difference −7.06%, 95% CI −11.01% to −3.11%) and at 36 months for total hip BMD (12-month difference −1.83%, 95% CI −4.23% to 0.56%; 36-month difference −5.14%, 95% CI −8.11% to −2.16%). Across the study periods, hormone use was associated with significantly less bone loss at both the spine and hip within the RRSO group compared with no hormone use (P<.001 at both 12 months and 36 months) but did not completely prevent bone loss (estimated percent change from baseline at 36 months −2.79%, 95% CI −5.08% to −0.51% for total spine BMD; −3.93%, 95% CI −7.27% to −0.59% for total hip BMD). CONCLUSION: Women with pathogenic variants in BRCA1/2 who undergo RRSO before the age of 50 years have greater bone loss after surgery that is clinically significant when compared with those who retain their ovaries. Hormone use mitigates, but does not eliminate, bone loss after RRSO. These results suggest that women who undergo RRSO may benefit from routine screening for BMD changes to identify opportunities for prevention and treatment of bone loss. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT01948609.

Objective: The aim of this study is to examine complementary and alternative medicine (CAM) use among women with symptomatic uterine fibroids in the United States. Materials and Methods: In this cross-sectional analysis of baseline data from a multicenter, prospective cohort study of premenopausal women undergoing surgery for symptomatic fibroids and who enrolled in the Uterine Leiomyoma Treatment with Radiofrequency Ablation study from 2017 to 2019, we contrast women indicating use of at least one CAM modality specifically for fibroid symptoms against women using CAM for other reasons and CAM nonusers. Multivariable logistic regression models were performed to identify participant characteristics independently associated with CAM use for fibroids. Results: Among 204 women, 55% were Black/African American and the mean age was 42 (standard deviation 6.6) years. CAM use was common (67%), with 42% (95% confidence interval [CI]: 35%-49%) reporting use of CAM specifically to treat fibroid symptoms. Most commonly, CAM treatments used for fibroids were diet (62%) and herbs (52%), while CAM treatments for other reasons were exercise (80%) and massage (43%). On average, each participant who reported CAM use utilized three different types of CAM modalities. In a multivariable model, participants were more likely to use CAM for fibroids if they had pelvic pressure (odds ratio [OR] 2.50, 95% CI: 1.07-5.87, p = 0.04), a body-mass index lower than average (OR 0.76, 95% CI: 0.60-0.97, p = 0.03), and a lower health-related quality of life score (OR 0.61, 95% CI: 0.46-0.81, p = 0.001). Conclusions: In this diverse sample of women with symptomatic fibroids, CAM use was highly prevalent. Our findings highlight the need for providers to query patients about CAM use and understand the role of CAM in fibroid management. ClinicalTrials.gov Identifier: NCT02100904.