Beyond the bladder: poor sleep in women with overactive bladder syndrome.

BACKGROUND: Nocturnal bladder symptoms and sleep disruption commonly coexist in middle-aged and older women. Although sleep disruption is often attributed to nocturnal bladder symptoms in women with overactive bladder syndrome, nonbladder factors also may influence sleep in this population. Many women with overactive bladder are eager to identify nonpharmacologic strategies for both bladder symptoms and sleep disruption, given the potential adverse effects of sedative and anticholinergic bladder medications in this population. OBJECTIVES: To provide greater insight into the complex relationship between nighttime overactive bladder symptoms and sleep disruption, and to evaluate the effects of a guided slow-paced respiration intervention on sleep outcomes in women with overactive bladder. STUDY DESIGN: We conducted an ancillary study within a randomized trial of slow-paced respiration in women with overactive bladder symptoms. Ambulatory community-dwelling women who reported ≥3 episodes/day of urgency-associated voiding or incontinence were randomized to use either a portable biofeedback device (RESPeRATE; Intercure, Ltd) to practice guided slow-paced respiration exercises daily for 12 weeks (N=79) or an identical-appearing device programmed to play nonrhythmic music without guiding breathing (N=82). At baseline and after 12 weeks, bladder symptoms were assessed by voiding diary, sleep duration, and disruption were assessed by sleep diary corroborated by wrist actigraphy, and poor sleep quality was determined by a Pittsburgh Sleep Quality Index global score >5. RESULTS: Of the 161 women randomized, 31% reported at least twice-nightly nocturia, 26% nocturnal incontinence, and 70% poor sleep quality at baseline. Of the 123 reporting any nighttime awakenings, 89% averaged 1 or more nighttime awakenings, and 83% attributed at least half of awakenings to using the bathroom. Self-reported wake time after sleep onset increased with increasing frequency of nocturnal bladder symptoms (P=.01 for linear trend). However, even among women without nocturia, average sleep quality was poor (Pittsburg Sleep Quality Index global score mean of 7.3; 95% confidence interval, 6.0-8.6). Over 12 weeks, women assigned to slow-paced respiration (N=79) experienced modest improvements in mean nocturnal voiding frequency (0.4 fewer voids/night), sleep quality (1.1 point score decrease), and sleep disruption (1.5% decreased wake time after sleep onset). However, similar improvements were detected in the music control group (N=81), without significant between-group differences. CONCLUSIONS: Many women with overactive bladder syndrome experience disrupted sleep, but not all nocturnal awakenings are attributable to bladder symptoms, and average sleep quality tends to be poor even in women without nocturia. Findings suggest that clinicians should not assume that poor sleep in women with overactive bladder syndrome is primarily caused by nocturnal bladder symptoms. Guided slow-paced respiration was associated with modest improvements in nocturia frequency and sleep quality in this trial, but the results do not support clinician recommendation to use this technique over other behavioral relaxation techniques for improving sleep.

Laparoscopic Radiofrequency Ablation of Uterine Leiomyomas: Clinical Outcomes during Early Adoption into Surgical Practice.

STUDY OBJECTIVE: To assess surgical outcomes, clinical effectiveness, and gynecologist experience of introducing laparoscopic radiofrequency ablation (RFA) of leiomyomas into surgical practice. DESIGN: Uncontrolled clinical trial. SETTING: Five academic medical centers across California. PATIENTS: Premenopausal women with symptomatic uterine leiomyomas, uterus size ≤16 weeks size, and all leiomyomas ≤10 cm with no more than 6 total leiomyomas. INTERVENTIONS: Laparoscopic RFA of leiomyomas. MEASUREMENTS AND MAIN RESULTS: We assessed intraoperative complications, blood loss, operative time, and adverse events. Gynecologists reported the operative difficulty and need for further training after each case. Participants reported leiomyoma symptoms preoperatively and at 6 and 12 weeks after surgery. We analyzed all outcome data from the first case performed by gynecologists with no previous RFA experience. Patient demand for RFA was high, but poor insurance authorization prevented 74% of eligible women from trial participation; 26 women underwent surgery and were enrolled. The mean age of the participants was 41.5 ± 4.9 years. The mean operating time was 153 ± 51 minutes, and mean estimated blood loss was 24 ± 40 cc. There were no intraoperative complications and no major adverse events. Menstrual bleeding, sexual function, and quality of life symptoms improved significantly from baseline to 12 weeks, with a 25 ± 18-point, or 47%, decrease in the Leiomyoma Symptom Severity Score. After the first procedure, the mean difficulty score was 6 (95% confidence interval [CI], 4-7.5) on a 10-point scale, and 89% of surgeons felt "very or somewhat" confident in performing laparoscopic RFA. The difficulty score decreased to 4.25 (95% CI, 1.2-6) after the fourth procedure, with all gynecologists reporting surgical confidence. CONCLUSION: Laparoscopic RFA of leiomyomas can be introduced into surgical practice with good clinical outcomes for patients. Gynecologists with no previous experience are able to gain confidence and skill with the procedure in fewer than 5 cases.

A Randomized Controlled Trial of Device Guided, Slow-Paced Respiration in Women with Overactive Bladder Syndrome.

PURPOSE: We evaluated the effects of device guided, slow-paced respiration on urgency associated urinary symptoms, perceived stress and anxiety, and autonomic function in women with overactive bladder syndrome. MATERIALS AND METHODS: We performed a randomized, parallel group trial of slow-paced respiration to improve perceived stress and autonomic dysfunction as potential contributors to overactive bladder. Ambulatory women who reported at least 3 voiding or incontinence episodes per day associated with moderate to severe urgency were randomized to use a portable biofeedback device to practice daily, slow, guided breathing exercises or a control device which appeared identical and was reprogrammed to play music without guiding breathing. During 12 weeks we evaluated changes in urinary symptoms by voiding diaries, perceived stress and anxiety by validated questionnaires, and autonomic function by heart rate variability and impedance cardiography. RESULTS: In the 161 randomized participants, including 79 randomized to paced respiration and 82 randomized to the control group, the average ± SD baseline frequency of voiding or incontinence associated with moderate to severe urgency was 6.9 ± 3.4 episodes per day. Compared to controls the participants randomized to paced respiration demonstrated greater improvement in perceived stress (average Perceived Stress Scale score decrease 2.8 vs 1.1, p=0.03) but not in autonomic function markers. During 12 weeks the average frequency of voiding or incontinence associated with moderate to severe urgency, which was the study primary outcome, decreased by a mean of 0.9 ± 3.2 episodes per day but no significant between group difference was detected. CONCLUSIONS: Among women with overactive bladder slow-paced respiration was associated with a modest improvement in perceived stress during 12 weeks. However, it was not superior to a music listening control for reducing urinary symptoms or changing autonomic function.

A group-based yoga program for urinary incontinence in ambulatory women: feasibility, tolerability, and change in incontinence frequency over 3 months in a single-center randomized trial.

BACKGROUND: Because of the limitations of existing clinical treatments for urinary incontinence, many women with incontinence are interested in complementary strategies for managing their symptoms. Yoga has been recommended as a behavioral self-management strategy for incontinence, but evidence of its feasibility, tolerability, and efficacy is lacking. OBJECTIVE: To evaluate the feasibility and tolerability of a group-based therapeutic yoga program for ambulatory middle-aged and older women with incontinence, and to examine preliminary changes in incontinence frequency as the primary efficacy outcome after 3 months. MATERIALS AND METHODS: Ambulatory women aged 50 years or older who reported at least daily stress-, urgency-, or mixed-type incontinence, were not already engaged in yoga, and were willing to temporarily forgo clinical incontinence treatments were recruited into a randomized trial in the San Francisco Bay area. Women were randomly assigned to take part in a program of twice-weekly group classes and once-weekly home practice focused on Iyengar-based yoga techniques selected by an expert yoga panel (yoga group), or a nonspecific muscle stretching and strengthening program designed to provide a rigorous time-and-attention control (control group) for 3 months. All participants also received written, evidence-based information about behavioral incontinence self-management techniques (pelvic floor exercises, bladder training) consistent with usual first-line care. Incontinence frequency and type were assessed by validated voiding diaries. Analysis of covariance models examined within- and between-group changes in incontinence frequency as the primary efficacy outcome over 3 months. RESULTS: Of the 56 women randomized (28 to yoga, 28 to control), the mean age was 65.4 (±8.1) years (range, 55-83 years), the mean baseline incontinence frequency was 3.5 (±2.0) episodes/d, and 37 women (66%) had urgency-predominant incontinence. A total of 50 women completed their assigned 3-month intervention program (89%), including 27 in the yoga and 23 in the control group (P = .19). Of those, 24 (89%) in the yoga and 20 (87%) in the control group attended at least 80% of group classes. Over 3 months, total incontinence frequency decreased by an average of 76% from baseline in the yoga and 56% in the control group (P = .07 for between-group difference). Stress incontinence frequency also decreased by an average of 61% in the yoga group and 35% in controls (P = .045 for between-group difference), but changes in urgency incontinence frequency did not differ significantly between groups. A total of 48 nonserious adverse events were reported, including 23 in the yoga and 25 in the control group, but none were directly attributable to yoga or control program practice. CONCLUSION: Findings demonstrate the feasibility of recruiting and retaining incontinent women across the aging spectrum into a therapeutic yoga program, and provide preliminary evidence of reduction in total and stress-type incontinence frequency after 3 months of yoga practice. When taught with attention to women's clinical needs, yoga may offer a potential community-based behavioral self-management strategy for incontinence to enhance clinical treatment, although future research should assess whether yoga offers unique benefits for incontinence above and beyond other physical activity-based interventions.

Development and Feasibility of a Group-Based Therapeutic Yoga Program for Women with Chronic Pelvic Pain.

OBJECTIVE: To develop a group-based therapeutic yoga program for women with chronic pelvic pain (CPP) and explore the effects of this program on pain severity, sexual function, and well-being. METHODS: A yoga therapy program for CPP was developed by a multidisciplinary panel of clinicians, researchers, and yoga consultants. Women reporting moderate to severe pelvic pain for at least six months were recruited into a single-arm trial. Participants attended twice weekly group classes focusing on Iyengar-based yoga techniques and were instructed to practice yoga at home an hour a week for six weeks. Participants self-rated the severity of their pelvic pain using daily logs. The impact of participants' pain on everyday activities, emotional well-being, and sexual function was assessed using an Impact of Pelvic Pain (IPP) questionnaire. Sexual function was further assessed using the Sexual Health Outcomes in Women Questionnaire (SHOW-Q). RESULTS: Among the 16 participants (age range = 31-64 years), average ratings of the severity of pain "at its worst," "at its best," and "on average" decreased by 29%, 32%, and 34%, respectively, from start to six weeks (P < 0.05 for all). Women demonstrated improvements in scores on IPP subscales for daily activities (1.8 ± 0.7 to 0.9 ± 0.7, P < 0.001), emotional well-being (1.7 ± 0.9 to 0.9 ± 0.7, P = 0.005), and sexual function (1.9 ± 1.1 to 1.0 ± 0.9, P = 0.04). Scores on the SHOW-Q "pelvic problem interference" scale also improved over six weeks (53 ± 23 to 27 ± 23, P = 0.002). CONCLUSIONS: Findings provide preliminary evidence of the feasibility of teaching women with CPP to practice yoga to self-manage pain and improve quality of life and sexual function.

Urinary incontinence management costs are reduced following Burch or sling surgery for stress incontinence.

OBJECTIVE: The objective of the study was to estimate the effect of Burch and fascial sling surgery on out-of-pocket urinary incontinence (UI) management costs at 24 months postoperatively and identify predictors of change in cost among women enrolled in a randomized trial comparing these procedures. STUDY DESIGN: Resources used for UI management (supplies, laundry, dry cleaning) were self-reported by 491 women at baseline and 24 months after surgery, and total out-of-pocket costs for UI management (in 2012 US dollars) were estimated. Data from the 2 surgical groups were combined to examine the change in cost for UI management over 24 months. Univariate and bivariate changes in cost were analyzed using the Wilcoxon signed rank test. Predictors of change in cost were examined using multivariate mixed models. RESULTS: At baseline mean (±SD) age of participants was 53 ± 10 years, and the frequency of weekly UI episodes was 23 ± 21. Weekly UI episodes decreased by 86% at 24 months (P < .001). The mean weekly cost was $16.60 ± $27.00 (median $9.39) at baseline and $4.57 ± $15.00 (median $0.10) at 24 months (P < .001), a decrease of 72%. In multivariate analyses, cost decreased by $3.38 ± $0.77 per week for each decrease of 1 UI episode per day (P < .001) and was strongly associated with greater improvement in Urogenital Distress Inventory and Incontinence Impact Questionnaire scores (P < .001) and decreased 24-hour pad weight (P < .02). CONCLUSION: Following Burch or fascial sling surgery, the UI management cost at 24 months decreased by 72% ($625 per woman per year) and was strongly associated with decreasing UI frequency. Reduced out-of-pocket expenses may be a benefit of these established urinary incontinence procedures.

Adding evidence-based behavioral weight loss strategies to a statewide wellness campaign: a randomized clinical trial.

OBJECTIVES: We determined the efficacy and cost-effectiveness of adding an evidence-based Internet behavioral weight loss intervention alone or combined with optional group sessions to ShapeUp Rhode Island 2011 (SURI), a 3-month statewide wellness campaign. METHODS: We randomized participants (n = 230; body mass index = 34.3 ±6.8 kg/m(2); 84% female) to the standard SURI program (S) or to 1 of 2 enhanced programs: SURI plus Internet behavioral program (SI) or SI plus optional group sessions (SIG). The primary outcome was weight loss at the end of the 3-month program. RESULTS: Weight losses differed among all 3 conditions (S: 1.1% ±0.9%; SI: 4.2% ±0.6%; SIG: 6.1% ±0.6%; Ps ≤ .04). Both SI and SIG increased the percentage of individuals who achieved a 5% weight loss (SI: 42%; SIG: 54%; S: 7%; Ps < .001). Cost per kilogram of weight loss was similar for S ($39) and SI ($35); both were lower than SIG ($114). CONCLUSIONS: Although weight losses were greatest at the end of SURI with optional group sessions, the addition of an Internet behavioral program was the most cost-effective method to enhance weight losses.

Pregnancy Outcomes After Laparoscopic Radiofrequency Ablation of Uterine Leiomyomas Compared With Myomectomy.

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.

Long-term efficacy and safety of questionnaire-based initiation of urgency urinary incontinence treatment.

OBJECTIVE: The objective of the study was to determine the longer-term efficacy and safety of initiating treatment for urgency-predominant urinary incontinence (UUI) in women diagnosed using a simple questionnaire rather than an extensive evaluation. STUDY DESIGN: Women completing a 12 week randomized controlled trial of fesoterodine therapy for UUI diagnosed by questionnaire were invited to participate in a 9 month, open-label continuation study. UUI and voiding episodes were collected using voiding diaries. Participant satisfaction was measured by questionnaire. Safety was assessed by the measurement of postvoid residual volume and adverse event monitoring; if necessary, women underwent a specialist evaluation. The longitudinal changes in UUI and voiding episodes were evaluated using linear mixed models adjusting for baseline. RESULTS: Of the 567 women completing the randomized trial, 498 (87.8%) took at least 1 dose of medication during this open-label study. Compared with the baseline visit in the randomized trial, fesoterodine was associated with a reduction in total incontinence episodes per day and urgency incontinence episodes per day at the end of the open-label study (adjusted mean [SE], 4.6 [0.12] to 1.2 [0.13] and 3.9 [0.11] to 0.9 [0.11], respectively, P < .0001 for both). Most women were satisfied with treatment (89%, 92%, and 93% at 3, 6, and 9 months, respectively). Twenty-six women experienced 28 serious adverse events, 1 of which was considered possibly treatment related. Twenty-two women had a specialist evaluation: 5 women's incontinence was misclassified by the 3 Incontinence Questions; none experienced harm because of misclassification. CONCLUSION: Using a simple validated questionnaire to diagnose and initiate treatment for UUI in community-dwelling women is safe and effective, allowing timely treatment by primary care practitioners.

TReating Incontinence for Underlying Mental and Physical Health (TRIUMPH): a study protocol for a multicenter, double-blinded, randomized, 3-arm trial to evaluate the multisystem effects of pharmacologic treatment strategies for urgency-predominant urinary incontinence in ambulatory older women.

BACKGROUND: Urgency-type urinary incontinence affects one in four older community-dwelling women and overlaps with other common aging-associated health syndromes such as cognitive impairment, physical mobility impairment, and depression. Observational studies have raised concern about potentially higher rates of delirium and dementia in older adults taking anticholinergic bladder medications, but few prospective data are available to evaluate the effects of these and other pharmacologic treatments for urgency incontinence on cognition and other multisystem functional domains important to older women. METHODS: The TRIUMPH study is a randomized, double-blinded, 3-arm, parallel-group trial comparing the multisystem effects of anticholinergic versus beta-3-adrenergic agonist bladder therapy and versus no active bladder anti-spasmodic pharmacotherapy in older women with urgency incontinence. Women aged 60 years and older (target N = 270) who have chronic urgency-predominant urinary incontinence and either normal or mildly impaired cognition at baseline are recruited from the community by investigators based in northern California, USA. Participants are randomized in equal ratios to take identically encapsulated oral anticholinergic bladder therapy (in the form of tolterodine 2 mg extended release [ER]), oral beta-3 adrenergic agonist bladder therapy (mirabegron 25 mg ER), or placebo daily for 24 weeks, with the option of participant-directed dose titration (to tolterodine 4 mg ER, mirabegron 50 mg ER, or matching placebo daily). Participants also receive patient-oriented information and instructions about practicing first-line behavioral management strategies for incontinence. The primary outcome is change in composite cognitive function over 24 weeks assessed by a comprehensive battery of cognitive tests, with a secondary exploration of the persistence of change at 36 weeks. Secondary outcomes include changes over 24 and 36 weeks in domain-specific cognitive function; frequency, severity, and impact of urgency-associated urinary symptoms; physical function and balance; sleep quality and daytime sleepiness; psychological function; and bowel function. DISCUSSION: The TRIUMPH trial addresses the need for rigorous evidence to guide counseling and decision-making for older women who are weighing the potential multisystem benefits and risks of pharmacologic treatments for urgency incontinence in order to preserve their day-to-day functioning, quality of life, and independence in older age. TRIAL REGISTRATION: ClinicalTrials.gov NCT05362292. Registered on May 5, 2022.

Efficacy of Continuous Transdermal Nitroglycerin for Treating Hot Flashes by Inducing Nitrate Cross-tolerance in Perimenopausal and Postmenopausal Women: A Randomized Clinical Trial.

Importance: Due to the potential risks of long-term systemic estrogen therapy, many menopausal women are interested in nonhormonal treatments for vasomotor symptoms. Physiologic studies indicate that nitric oxide plays a key role in mediating hot flash-related vasodilation, suggesting that nonhormonal medications that induce nitrate tolerance in the vasculature may offer therapeutic benefit for vasomotor symptoms. Objective: To determine whether uninterrupted administration of transdermal nitroglycerin (NTG) to induce nitrate cross-tolerance decreased the frequency or severity of menopause-related hot flashes. Design, Setting, and Participants: This randomized, double-blinded, placebo-controlled clinical trial included perimenopausal or postmenopausal women reporting 7 or more hot flashes per day who were recruited from northern California by study personnel at a single academic center. Patients were randomized between July 2017 and December 2021, and the trial ended in April 2022 when the last randomized participant completed follow-up. Interventions: Uninterrupted daily use of transdermal NTG (participant-directed dose titration from 0.2-0.6 mg/h) or identical placebo patches. Main Outcome Measures: Validated symptom diaries assessing changes in any hot flash frequency (primary outcome) and moderate-to-severe hot flash frequency over 5 and 12 weeks. Results: Among the 141 randomized participants (70 NTG [49.6%], 71 placebo [50.4%]; 12 [85.8%] Asian, 16 [11.3%] Black or African American, 15 [10.6%] Hispanic or Latina, 3 [2.1%] multiracial, 1 [0.7%] Native Hawaiian or Pacific Islander, and 100 [70.9%] White or Caucasian individuals), a mean (SD) of 10.8 (3.5) hot flashes and 8.4 (3.6) moderate-to-severe hot flashes daily was reported at baseline. Sixty-five participants assigned to NTG (92.9%) and 69 assigned to placebo (97.2%) completed 12-week follow-up (P = .27). Over 5 weeks, the estimated change in any hot flash frequency associated with NTG vs placebo was -0.9 (95% CI, -2.1 to 0.3) episodes per day (P = .10), and change in moderate-to-severe hot flash frequency with NTG vs placebo was -1.1 (95% CI, -2.2 to 0) episodes per day (P = .05). At 12 weeks, treatment with NTG did not significantly decrease the frequency of any hot flashes (-0.1 episodes per day; 95% CI, -1.2 to 0.4) or moderate-to-severe hot flashes (-0.5 episodes per day; 95% CI, -1.6 to 0.7) relative to placebo. In analyses combining 5-week and 12-week data, no significant differences in change in the frequency of any hot flashes (-0.5 episodes per day; 95% CI, -1.6 to 0.6; P = .25) or moderate-to-severe hot flashes (-0.8 episodes per day; 95% CI, -1.9 to 0.2; P = .12) were detected with NTG vs placebo. At 1 week, 47 NTG (67.1%) and 4 placebo participants (5.6%) reported headache (P < .001), but only 1 participant in each group reported headache at 12 weeks. Conclusions and Relevance: This randomized clinical trial found that continuous use of NTG did not result in sustained improvements in hot flash frequency or severity relative to placebo and was associated with more early but not persistent headache. Trial Registration: Clinicaltrials.gov Identifier: NCT02714205.

Changes in Bone Density in Carriers of BRCA1 and BRCA2 Pathogenic Variants After Salpingo-Oophorectomy.

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.

Complementary and Alternative Medicine Use Among Women with Symptomatic Uterine Fibroids.

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.

Pharmacologic treatment for urgency-predominant urinary incontinence in women diagnosed using a simplified algorithm: a randomized trial.

OBJECTIVE: The purpose of this study was to evaluate clinical outcomes associated with the initiation of treatment for urgency-predominant incontinence in women diagnosed by a simple 3-item questionnaire. STUDY DESIGN: We conducted a multicenter, double-blinded, 12-week randomized trial of pharmacologic therapy for urgency-predominant incontinence in ambulatory women diagnosed by the simple 3-item questionnaire. Participants (N = 645) were assigned randomly to fesoterodine therapy (4-8 mg daily) or placebo. Urinary incontinence was assessed with the use of voiding diaries; postvoid residual volume was measured after treatment. RESULTS: After 12 weeks, women who had been assigned randomly to fesoterodine therapy reported 0.9 fewer urgency and 1.0 fewer total incontinence episodes/day, compared with placebo (P ≤ .001). Four serious adverse events occurred in each group, none of which was related to treatment. No participant had postvoid residual volume of ≥ 250 mL after treatment. CONCLUSION: Among ambulatory women with urgency-predominant incontinence diagnosed with a simple 3-item questionnaire, pharmacologic therapy resulted in a moderate decrease in incontinence frequency without increasing significant urinary retention or serious adverse events, which provides support for a streamlined algorithm for diagnosis and treatment of female urgency-predominant incontinence.

Rapid Conversion of a Group-Based Yoga Trial for Diverse Older Women to Home-Based Telehealth: Lessons Learned Using Zoom to Deliver Movement-Based Interventions.

This brief report describes the rapid conversion of a randomized trial of a Hatha-based yoga program for older women with urinary incontinence to a telehealth videoconference platform during the coronavirus disease 2019 (COVID-19) pandemic. Interim results demonstrate the feasibility of recruiting and retaining participants across a wide range of ages and ethnic backgrounds, but also point to potential obstacles and safety concerns arising from telehealth-based instruction. The investigators present lessons learned about the benefits and challenges of using telehealth platforms to deliver movement-based interventions and consider strategies to promote accessible and well-tolerated telehealth-based yoga programs for older and diverse populations. Clinical Trial Registration number: NCT03672461.

Symptom resolution after hysterectomy and alternative treatments for chronic pelvic pain: does depression make a difference?

OBJECTIVE: The purpose of this study was to determine whether depression influences treatment outcomes and to identify predictors of symptom resolution among women with chronic pelvic pain (CPP). STUDY DESIGN: Analysis of 701 women with CPP in the Study of Pelvic Problems, Hysterectomy and Intervention Alternatives prospective cohort study, which included 153 women (22%) with depression. We conducted multivariable analyses to evaluate the influence of depression on pre-/posttreatment differences in symptoms and health-related quality of life and to identify other predictors of symptom improvement. RESULTS: CPP treatments included hysterectomy (9%), other surgical treatments (9%), hormonal medications (50%), narcotic analgesics (47%), physical therapy (12%), and nonprescription medications (93%). Depression predicted lower gains in health perception (P < .05) but not in symptom resolution, sexual functioning, or other aspects of health-related quality of life. Symptom resolution was predicted by hysterectomy (P < .001), entering menopause (P < .001), and pretreatment satisfaction with sex (P = .039). CONCLUSION: Depression does not influence substantially treatment-related gains in CPP symptom resolution and health-related quality of life. Coexisting depression should not delay treatment for CPP.

Parturition events and risk of urinary incontinence in later life.

AIMS: To examine the association between specific events during vaginal deliveries and urinary incontinence later in life. METHODS: A retrospective cohort study of 1,521 middle-aged and older women with at least one vaginal delivery who were long-term members of an integrated health delivery system. Age, race/ethnicity, current incontinence status, medical, surgical history, pregnancy and parturition history, menopausal status, hormone replacement, health habits, and general health were obtained by questionnaire. Labor and delivery records, archived since 1948, were abstracted by professional medical record abstractors to obtain parturition events including induction, length of labor stages, type of anesthesia, episiotomy, instrumental delivery, and birth weight. The primary dependent variable was current weekly urinary incontinence (once per week or more often) versus urinary incontinence less than monthly (including no incontinence) in past 12 months. Associations of parturition events and later incontinence were assessed in multivariate analysis with logistic regression. RESULTS: The mean age of participants was 56 years. After adjustment for multiple risk factors, weekly urinary incontinence significantly associated with age at first birth (P = 0.036), greatest birth weight (P = 0.005), and ever having been induced for labor (OR = 1.51; 95%CI = 1.06-2.16, P = 0.02). Risk of incontinence increased from OR = 1.35 (95%CI = 0.92-1.97, P = 0.12) for women with one induction to OR = 2.67 (95%CI = 1.25-5.71, P = 0.01) for women with two or more inductions (P = 0.01 for trend). No other parturition factors were associated with incontinence. CONCLUSIONS: Younger age at first birth, greatest birth weight, and induction of labor were associated with an increased risk of incontinence in later life.

Urinary incontinence self-report questions: reproducibility and agreement with bladder diary.

INTRODUCTION AND HYPOTHESIS: This study aims to measure self-report urinary incontinence questions' reproducibility and agreement with bladder diary. METHODS: Data were analyzed from the Reproductive Risk of Incontinence Study at Kaiser. Participating women reporting at least weekly incontinence completed self-report incontinence questions and a 7-day bladder diary. Self-report question reproducibility was assessed and agreement between self-reported and diary-recorded voiding and incontinence frequency was measured. Test characteristics and area under the curve were calculated for self-reported incontinence types using diary as the gold standard. RESULTS: Five hundred ninety-one women were included and 425 completed a diary. The self-report questions had moderate reproducibility and self-reported and diary-recorded incontinence and voiding frequencies had moderate to good agreement. Self-reported incontinence types identified stress and urgency incontinence more accurately than mixed incontinence. CONCLUSIONS: Self-report incontinence questions have moderate reproducibility and agreement with diary, and considering their minimal burden, are acceptable research tools in epidemiologic studies.

Incidence of and risk factors for change in urinary incontinence status in a prospective cohort of middle-aged and older women: the reproductive risk of incontinence study in Kaiser.

PURPOSE: Urinary incontinence is a dynamic condition that can progress and regress but few groups have examined risk factors for change in incontinence status. MATERIAL AND METHODS: We used stratified random sampling to construct a racially and ethnically diverse, population based cohort of 2,109 women 40 to 69 years old. Data were collected by questionnaires and medical record review. A second survey approximately 5 years later was completed by 1,413 women (67%) from the original cohort. The frequency of urinary incontinence was categorized as less than weekly, weekly and daily. Change in incontinence status was defined as new onset incontinence, incontinence progression or regression between frequency categories and resolution of incontinence. Predictor variables were demographics, body mass index and other medical conditions. We used logistic regression to estimate the adjusted OR and 95% CI. RESULTS: Compared to white nonHispanic women, black women were less likely to have incontinence progression (OR 0.46, 95% CI 0.24-0.88). New onset incontinence was more common in women with a higher body mass index at baseline (p = 0.006) and those who experienced increased body mass index (p = 0.03) or decreased general health (p = 0.007) during the study. Participants with chronic obstructive pulmonary disorder at baseline were more likely to report incontinence progression (OR 2.64, 95% CI 1.22-5.70). Baseline incontinence type was not significantly associated with the risk of change in continence status independent of frequency. CONCLUSIONS: Identifying risk factors for change in incontinence status may be important to develop interventions to decrease the burden of incontinence in the general population.

Women with diabetes: understanding urinary incontinence and help seeking behavior.

PURPOSE: We examined the association of urinary incontinence with diabetes status and race, and evaluated beliefs about help seeking for incontinence in a population based cohort of women with vs without diabetes. MATERIALS AND METHODS: We performed a cross-sectional analysis of 2,270 middle-aged and older racially/ethnically diverse women in the Diabetes Reproductive Risk factors for Incontinence Study at Kaiser. Incontinence, help seeking behavior and beliefs were assessed by self-report questionnaires and in-person interviews. We compared incontinence characteristics in women with and without diabetes using univariate analysis and multivariate models. RESULTS: Women with diabetes reported weekly incontinence significantly more than women without diabetes (weekly 35.4% vs 25.7%, p <0.001). Race prevalence patterns were similar in women with and without diabetes with the most vs the least prevalence of incontinence in white and Latina vs black and Asian women. Of women with diabetes 42.2% discussed incontinence with a physician vs 55.5% without diabetes (p <0.003). Women with diabetes were more likely than those without diabetes to report the belief that incontinence is rare (17% vs 6%, p <0.001). CONCLUSIONS: Incontinence is highly prevalent in women with diabetes. Race prevalence patterns are similar in those with and without diabetes. Understanding help seeking behavior is important to ensure appropriate patient care. Physicians should be alert for urinary incontinence since it is often unrecognized and, thus, under treated in women with diabetes.