Hearing intervention versus health education control to reduce cognitive decline in older adults with hearing loss in the USA (ACHIEVE): a multicentre, randomised controlled trial.

BACKGROUND: Hearing loss is associated with increased cognitive decline and incident dementia in older adults. We aimed to investigate whether a hearing intervention could reduce cognitive decline in cognitively healthy older adults with hearing loss. METHODS: The ACHIEVE study is a multicentre, parallel-group, unmasked, randomised controlled trial of adults aged 70-84 years with untreated hearing loss and without substantial cognitive impairment that took place at four community study sites across the USA. Participants were recruited from two study populations at each site: (1) older adults participating in a long-standing observational study of cardiovascular health (Atherosclerosis Risk in Communities [ARIC] study), and (2) healthy de novo community volunteers. Participants were randomly assigned (1:1) to a hearing intervention (audiological counselling and provision of hearing aids) or a control intervention of health education (individual sessions with a health educator covering topics on chronic disease prevention) and followed up every 6 months. The primary endpoint was 3-year change in a global cognition standardised factor score from a comprehensive neurocognitive battery. Analysis was by intention to treat. This trial was registered at ClinicalTrials.gov, NCT03243422. FINDINGS: From Nov 9, 2017, to Oct 25, 2019, we screened 3004 participants for eligibility and randomly assigned 977 (32·5%; 238 [24%] from ARIC and 739 [76%] de novo). We randomly assigned 490 (50%) to the hearing intervention and 487 (50%) to the health education control. The cohort had a mean age of 76·8 years (SD 4·0), 523 (54%) were female, 454 (46%) were male, and most were White (n=858 [88%]). Participants from ARIC were older, had more risk factors for cognitive decline, and had lower baseline cognitive scores than those in the de novo cohort. In the primary analysis combining the ARIC and de novo cohorts, 3-year cognitive change (in SD units) was not significantly different between the hearing intervention and health education control groups (-0·200 [95% CI -0·256 to -0·144] in the hearing intervention group and -0·202 [-0·258 to -0·145] in the control group; difference 0·002 [-0·077 to 0·081]; p=0·96). However, a prespecified sensitivity analysis showed a significant difference in the effect of the hearing intervention on 3-year cognitive change between the ARIC and de novo cohorts (pinteraction=0·010). Other prespecified sensitivity analyses that varied analytical parameters used in the total cohort did not change the observed results. No significant adverse events attributed to the study were reported with either the hearing intervention or health education control. INTERPRETATION: The hearing intervention did not reduce 3-year cognitive decline in the primary analysis of the total cohort. However, a prespecified sensitivity analysis showed that the effect differed between the two study populations that comprised the cohort. These findings suggest that a hearing intervention might reduce cognitive change over 3 years in populations of older adults at increased risk for cognitive decline but not in populations at decreased risk for cognitive decline. FUNDING: US National Institutes of Health.

Military Sexual Trauma and Menopause Symptoms Among Midlife Women Veterans.

BACKGROUND: Sexual assault and/or sexual harassment during military service (military sexual trauma (MST)) can have medical and mental health consequences. Most MST research has focused on reproductive-aged women, and little is known about the long-term impact of MST on menopause and aging-related health. OBJECTIVE: Examine associations of MST with menopause and mental health outcomes in midlife women Veterans. DESIGN: Cross-sectional. PARTICIPANTS: Women Veterans aged 45-64 enrolled in Department of Veterans Affairs (VA) healthcare in Northern California between March 2019 and May 2020. MAIN MEASURES: Standardized VA screening questions assessed MST exposure. Structured-item questionnaires assessed vasomotor symptoms (VMS), vaginal symptoms, sleep difficulty, depressive symptoms, anxiety symptoms, and posttraumatic stress disorder (PTSD) symptoms. Multivariable logistic regression analyses examined associations between MST and outcomes based on clinically relevant menopause and mental health symptom thresholds. KEY RESULTS: Of 232 participants (age = 55.95 ± 5.13), 73% reported MST, 66% reported VMS, 75% reported vaginal symptoms, 36% met criteria for moderate-to-severe insomnia, and almost half had clinically significant mental health symptoms (33% depressive symptoms, 49% anxiety, 27% probable PTSD). In multivariable analyses adjusted for age, race, ethnicity, education, body mass index, and menopause status, MST was associated with the presence of VMS (OR 2.44, 95% CI 1.26-4.72), vaginal symptoms (OR 2.23, 95% CI 1.08-4.62), clinically significant depressive symptoms (OR 3.21, 95% CI 1.45-7.10), anxiety (OR 4.78, 95% CI 2.25-10.17), and probable PTSD (OR 6.74, 95% CI 2.27-19.99). Results did not differ when military sexual assault and harassment were disaggregated, except that military sexual assault was additionally associated with moderate-to-severe insomnia (OR 3.18, 95% CI 1.72-5.88). CONCLUSIONS: Exposure to MST is common among midlife women Veterans and shows strong and independent associations with clinically significant menopause and mental health symptoms. Findings highlight the importance of trauma-informed approaches to care that acknowledge the role of MST on Veteran women's health across the lifespan.

Hearing and vision impairment and social isolation over 8 years in community-dwelling older adults.

BACKGROUND: Little is known about the long-term impact of hearing and vision impairment on social isolation. This study quantifies the association between hearing, vision, and concurrent hearing and vision impairment (dual sensory impairment) and social isolation over 8 years among older adults. METHODS: Data were from the National Health and Aging Trends Study (NHATS), a cohort study (2011 - 2019) of U.S. Medicare beneficiaries aged 65 years and older. Social isolation was measured by a binary indicator incorporating four domains: living arrangement, core discussion network size, religious attendance, and social participation. Hearing, vision, and dual sensory impairments were measured by self-report and modeled categorically (no impairment [ref.], hearing impairment only, vision impairment only, dual sensory impairment). Associations between sensory impairments and odds of social isolation over 8 years were assessed using multivariate generalized logistic mixed models and adjusted for demographic and health characteristics. RESULTS: Among 5,552 participants, 18.9% self-reported hearing impairment, 4.8% self-reported vision impairment, and 2.3% self-reported dual sensory impairment. Over 8 years, hearing impairment only was associated with 28% greater odds of social isolation. Participants with hearing impairment only were more likely to live alone and have limited social participation. CONCLUSION: Greater clinical awareness of hearing impairment as a risk factor for social isolation can increase opportunities to identify and aid older adults who may benefit from resources and interventions to increase social connection and mitigate social isolation.

The Integration of Clinical Trials With the Practice of Medicine: Repairing a House Divided.

Importance: Optimal health care delivery, both now and in the future, requires a continuous loop of knowledge generation, dissemination, and uptake on how best to provide care, not just determining what interventions work but also how best to ensure they are provided to those who need them. The randomized clinical trial (RCT) is the most rigorous instrument to determine what works in health care. However, major issues with both the clinical trials enterprise and the lack of integration of clinical trials with health care delivery compromise medicine's ability to best serve society. Observations: In most resource-rich countries, the clinical trials and health care delivery enterprises function as separate entities, with siloed goals, infrastructure, and incentives. Consequently, RCTs are often poorly relevant and responsive to the needs of patients and those responsible for care delivery. At the same time, health care delivery systems are often disengaged from clinical trials and fail to rapidly incorporate knowledge generated from RCTs into practice. Though longstanding, these issues are more pressing given the lessons learned from the COVID-19 pandemic, heightened awareness of the disproportionate impact of poor access to optimal care on vulnerable populations, and the unprecedented opportunity for improvement offered by the digital revolution in health care. Four major areas must be improved. First, especially in the US, greater clarity is required to ensure appropriate regulation and oversight of implementation science, quality improvement, embedded clinical trials, and learning health systems. Second, greater adoption is required of study designs that improve statistical and logistical efficiency and lower the burden on participants and clinicians, allowing trials to be smarter, safer, and faster. Third, RCTs could be considerably more responsive and efficient if they were better integrated with electronic health records. However, this advance first requires greater adoption of standards and processes designed to ensure health data are adequately reliable and accurate and capable of being transferred responsibly and efficiently across platforms and organizations. Fourth, tackling the problems described above requires alignment of stakeholders in the clinical trials and health care delivery enterprises through financial and nonfinancial incentives, which could be enabled by new legislation. Solutions exist for each of these problems, and there are examples of success for each, but there is a failure to implement at adequate scale. Conclusions and Relevance: The gulf between current care and that which could be delivered has arguably never been wider. A key contributor is that the 2 limbs of knowledge generation and implementation-the clinical trials and health care delivery enterprises-operate as a house divided. Better integration of these 2 worlds is key to accelerated improvement in health care delivery.

Hearing loss and cognition: A protocol for ensuring speech understanding before neurocognitive assessment.

INTRODUCTION: Many neurocognitive evaluations involve auditory stimuli, yet there are no standard testing guidelines for individuals with hearing loss. The ensuring speech understanding (ESU) test was developed to confirm speech understanding and determine whether hearing accommodations are necessary for neurocognitive testing. METHODS: Hearing was assessed using audiometry. The probability of ESU test failure by hearing status was estimated in 2679 participants (mean age: 81.4 ± 4.6 years) using multivariate logistic regression. RESULTS: Only 2.2% (N = 58) of participants failed the ESU test. The probability of failure increased with hearing loss severity; similar results were observed for those with and without mild cognitive impairment or dementia. DISCUSSION: The ESU test is appropriate for individuals who have variable degrees of hearing loss and cognitive function. This test can be used prior to neurocognitive testing to help reduce the risk of hearing loss and compromised auditory access to speech stimuli causing poorer performance on neurocognitive evaluation.

Effect of Vitamin D Supplementation on Overactive Bladder and Urinary Incontinence Symptoms in Older Men: Ancillary Findings From a Randomized Trial.

PURPOSE: Our goal was to evaluate vitamin D supplementation for preventing or treating overactive bladder and urinary incontinence in men. MATERIALS AND METHODS: Ancillary study of men aged ≥55 years in VITAL (VITamin D and OmegA-3 TriaL). Randomized treatments included: vitamin D3 (cholecalciferol), marine omega-3 fatty acids, or matching placebo. Structured urinary incontinence questions measured the prevalence of overactive bladder at year 5 and urinary incontinence at years 2 and 5, along with incidence and progression of urinary incontinence from years 2 to 5. Prespecified subgroup analyses examined men with low baseline serum 25-hydroxyvitamin D (<20 ng/mL). RESULTS: Among the 11,486 men who provided data at year 2 and 10,474 at year 5, mean age was 68 years at year 2, with 23% racial/ethnic minorities. In primary analyses, vitamin D supplementation compared to placebo did not lower odds of overactive bladder at year 5 (OR 0.97, 95% CI 0.87-1.08) or weekly urinary incontinence at year 2 (OR 0.94, 95% CI 0.83-1.05) or year 5 (OR 0.98, 95% CI 0.88-1.09). We found interactions of baseline serum 25-hydroxyvitamin D level with vitamin D supplementation for overactive bladder (P value for interaction = .001), and secondarily, for any urinary incontinence at year 2 (P value for interaction = .05). Men with baseline 25-hydroxyvitamin D <20 ng/mL, who were assigned to vitamin D supplements, had lower odds of overactive bladder (OR 0.51, 95% CI 0.35-0.76) compared to placebo, yet higher odds of any urinary incontinence (OR 1.24, 95% CI 0.93-1.64). CONCLUSIONS: Overall, vitamin D supplementation did not improve overactive bladder or urinary incontinence compared to placebo. However, specific use of vitamin D in men with lower 25-hydroxyvitamin D levels had inconsistent findings.

Adverse Childhood Experiences and Aging-Associated Functional Impairment in a National Sample of Older Community-Dwelling Adults.

BACKGROUND: Prior research on the health implications of adverse childhood experiences (ACEs) has focused on early or midlife adults, not older adults who bear the greatest burden of health-related functional impairment. OBJECTIVE: To examine associations between ACEs, objectively measured physical mobility and cognitive impairment, and functional disability in older community-dwelling adults. DESIGN: Cross-sectional analysis. PARTICIPANTS: Community-dwelling older U.S. adults ages 50 years and older. MAIN MEASURES: Participants completed structured questionnaires assessing history of ACEs (childhood experience of violence/abuse, witnessing of violence, financial insecurity, parental separation, or serious illness), underwent standardized physical performance testing (tandem balance, 3-m walk, chair stand test) and cognitive testing (survey adaptation of the Montreal Cognitive Assessment), and reported functional disability (difficulty with activities of daily living). KEY RESULTS: Among the 3387 participants (aged 50 to 97 years; 54% female), 44% reported a history of one or more types of ACEs. Thirty-five percent met criteria for physical mobility impairment, 24% for cognitive impairment, and 24% for functional disability. After adjusting for age, gender, race, and ethnicity, participants reporting any ACE history were more likely to demonstrate physical mobility impairment (OR 1.30, 95% CI 1.11-1.52) and cognitive impairment (OR 1.26, 95% CI 1.03-1.54) and report functional disability (OR 1.69, 95% CI 1.38-2.07), compared to those with no ACE history. Childhood experience of violence was associated with greater physical mobility impairment (OR 1.38, 95% CI 1.11-1.71) and functional disability (OR 1.86, 95% CI 1.49-2.33). CONCLUSIONS: Older adults with a history of ACEs are more likely to experience physical and cognitive functional impairment, suggesting that efforts to mitigate ACEs may have implications for aging-associated functional decline. Findings support the need for trauma-informed approaches to geriatric care that consider the potential role of early life traumatic experiences in shaping or complicating late-life functional challenges.

Elder Mistreatment Experienced by Older Caregiving Adults: Results from a National Community-Based Sample.

BACKGROUND: With an aging population, older adults are increasingly serving as caregivers to others, which may increase their risk of adverse interpersonal experiences. OBJECTIVE: To investigate the prevalence and types of elder mistreatment experienced by older caregiving adults. DESIGN: Cross-sectional analysis PARTICIPANTS: National sample of community-dwelling US adults over age 60 in 2015-2016. MAIN MEASURES: Caregiving (assisting another adult with day-to-day activities) was assessed by interviewer-administered questionnaires. Experience of elder mistreatment was assessed by participant-reported questionnaire in three domains: emotional, physical, and financial. Multivariable logistic regression models examined associations between caregiving status and each domain of elder mistreatment, adjusting for age, race, ethnicity, gender, education, marital status, concomitant care-receiving status, overall physical and mental health, and cognitive function. Additional logistic regression models examined associations between being the primary caregiver (rather than a secondary caregiver) and each domain of mistreatment among older caregivers. KEY RESULTS: Of the 1898 participants over age 60 (including 1062 women and 836 men, 83% non-Hispanic white, and 64% married or partnered), 14% reported serving as caregivers for other adults, including 8% who considered themselves to be the primary caregiver. Among these older caregivers, 38% reported experiencing emotional, 32% financial, and 6% physical mistreatment after age 60. In multivariable models, caregiving was associated with experiencing both emotional mistreatment (AOR 1.61, 95% CI 1.15-2.25) and financial mistreatment (AOR 1.72, 95% CI 1.18-2.50). In analyses confined to caregiving older adults, those who served as primary rather than secondary caregivers for other adults had an over two-fold increased odds of emotional mistreatment (AOR 2.17, 95% CI 1.07, 4.41). CONCLUSION: In this national cohort of older community-dwelling adults, caregiving was independently associated with experiencing emotional and financial mistreatment after age 60. Findings suggest that efforts to prevent or mitigate elder mistreatment should put more emphasis on vulnerable older caregivers.

The association of hearing loss with frailty among community-dwelling older adults: findings from the National Health and Aging Trends Study.

BACKGROUND: The identification of modifiable risk factors is crucial for the prevention and/or reversal of frailty, which is associated with significant morbidity and mortality. Hearing loss affects two-thirds of older adults in the United States (U.S.) and is associated with physical and cognitive decline which may increase frailty risk. We investigated the association of hearing loss and hearing aid use with frailty and pre-frailty in a nationally representative sample of older adults in the U.S. METHODS: Cross-sectional analysis of the National Health and Aging Trends Study (2021 round). The better-hearing ear pure-tone average (BPTA) at speech-frequencies (0.5-4 kHz) was modeled continuously (per 10 dB) and categorically (no ≤ 25 dB, mild 26-40 dB, moderate or greater > 40 dB hearing loss). Hearing aid use was self-reported. The physical frailty phenotype (frail, pre-frail, robust) was determined based on Fried criteria: unintentional weight loss, exhaustion, low physical activity, weakness, slow walking speed. We used multinomial multivariable regression adjusted for sociodemographic and health characteristics (odds ratios [95% Confidence Intervals]). RESULTS: Among 2,361 participants (mean age = 81 years, 56% female, 19% Black), 860 (36%) had mild and 864 (37%) had moderate or greater hearing loss. Worse hearing was associated with greater odds of being frail versus robust (OR = 1.20 [1.05-1.38] per 10 dB difference). Categorically, moderate or greater hearing loss was associated with greater odds of being frail (OR = 1.84 [1.01-3.08]) and pre-frail (OR = 1.46 [1.01-2.10]) versus robust. Among 1,724 participants with hearing loss, compared to hearing aid users (N = 522), nonusers had greater odds of being frail (OR = 2.54 [1.54-4.18]) and pre-frail (OR = 1.51 [1.05-2.17]) versus robust, and frail versus pre-frail (OR = 1.68 [1.04-2.72]). CONCLUSIONS: In a nationally representative sample of older adults in the U.S., using gold-standard hearing measures and a validated frailty phenotype, hearing loss and lack of hearing aid use was cross-sectionally associated with frailty and pre-frailty. Future longitudinal studies are needed to establish if hearing loss is a risk factor for frailty, which may have significant clinical importance.

Concurrent hearing and vision impairment and 8-year memory decline in community-dwelling older adults.

BACKGROUND: Hearing and vision impairments are risk factors for cognitive decline; less is known about dual sensory impairment. This study quantifies the association between dual sensory impairment and 8-year change in memory among older adults. METHODS: Data (N = 5552) were from the National Health and Aging Trends Study. Memory (immediate/delayed word recall, subjective memory) was measured annually (2011 to 2019). Hearing and vision impairments were measured by self-report. Association between dual sensory impairment and 8-year change in memory was assessed using multivariate linear mixed effect models and generalized logistic mixed models. RESULTS: Rate of memory decline was most accelerated among participants with dual sensory impairment. For example, 8-year decline in delayed word recall was -1.03 (95% confidene interval: -1.29, -0.77) for dual sensory impairment versus -0.79 (-0.92, -0.67) for single and -0.56 (-0.63, -0.48) for no impairment. CONCLUSION: Older adults with dual sensory impairment may be at particularly higher risk for cognitive decline.

The association of perceived discrimination with dementia risk in Black older adults.

INTRODUCTION: Non-Hispanic Black, compared to non-Hispanic White, older adults are at increased risk for dementia. This may be due partly to greater exposure to psychosocial stressors, such as discrimination; however, few studies have examined this association. METHODS: We examined the association of perceived discrimination (e.g., everyday, lifetime, and discrimination burden) with dementia risk in 1583 Black adults co-enrolled in the Atherosclerosis Risk in Communities (ARIC) Study and the Jackson Heart Study (JHS). Perceived discrimination (defined continuously and using tertiles) was assessed at JHS Exam 1 (2000-2004; mean age ± SD:66.2 ± 5.5) and related to dementia risk through ARIC visit 6 (2017) using covariate-adjusted Cox proportional hazards models. RESULTS: Associations of perceived everyday, lifetime, and burden of discrimination with dementia risk were not supported in age-adjusted models or demographic- and cardiovascular health-adjusted models. Results were similar across sex, income, and education. DISCUSSION: In this sample, associations between perceived discrimination and dementia risk were not supported. HIGHLIGHTS: In Black older adults perceived discrimination not associated with dementia risk. Younger age and greater education linked to greater perceived discrimination. Older age and less education among factors associated with dementia risk. Factors increasing exposure to discrimination (education) are also neuroprotective.

Interpersonal violence and painful bladder symptoms in community-dwelling midlife to older women.

BACKGROUND: Women are more likely to present with genitourinary complaints immediately after exposure to interpersonal violence, but little is known about the long-term effects of violence on women's urologic health, including their susceptibility to bladder pain and infections. OBJECTIVE: To determine whether lifetime interpersonal violence exposure and current posttraumatic stress disorder (PTSD) symptoms are associated with the prevalence or severity of painful bladder symptoms and a greater lifetime history of antibiotic-treated urinary tract infections in community-dwelling midlife and older women. STUDY DESIGN: We examined the cross-sectional data from a multiethnic cohort of community-dwelling women aged 40 to 80 years enrolled in a northern California integrated healthcare system. Women completed structured self-report questionnaires about their past exposure to physical and verbal/emotional intimate partner violence and sexual assault. The symptoms of PTSD were assessed using the PTSD checklist for the Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition, Civilian version. Additional structured self-report measures assessed the current bladder pain, other lower urinary tract symptoms, and the history of antibiotic-treated urinary tract infections. Multivariable logistic regression models examined self-reported interpersonal violence exposure history and current PTSD symptoms in relation to current bladder pain and antibiotic-treated urinary tract infection history. RESULTS: Among 1974 women (39% non-Latina White, 21% Black, 20% Latina, and 19% Asian), 22% reported lifetime interpersonal violence exposure, 22% reported bladder pain, and 60% reported a history of ever having an antibiotic-treated urinary tract infection. Lifetime experiences of sexual assault (odds ratio, 1.39; [95% confidence interval, 1.02-1.88]) and current PTSD symptoms (odds ratio, 1.96; [95% confidence interval, 1.45-2.65]) were associated with current bladder pain. A lifetime experience of physical intimate partner violence was associated with having a urinary tract infection at any time in life previously (odds ratio, 1.38; [95% confidence interval, 1.00-1.86]), as was emotional intimate partner violence (odds ratio, 1.88; [95% confidence interval, 1.43-2.48]), sexual assault (odds ratio, 1.44; [95% confidence interval, 1.09-1.91]), and current PTSD symptoms (odds ratio, 1.54; [95% confidence interval, 1.16-2.03]). CONCLUSION: In this ethnically diverse, community-based cohort, lifetime interpersonal violence exposures and current PTSD symptoms were independently associated with current bladder pain and the lifetime history of antibiotic-treated urinary tract infections in midlife to older women. The findings suggest that interpersonal violence and PTSD symptoms may be underrecognized markers of risk for urologic pain and infections in women, highlighting a need for trauma-informed care of these issues.

Effect of vitamin D supplementation on urinary incontinence in older women: ancillary findings from a randomized trial.

BACKGROUND: Observational studies among older women have associated vitamin D insufficiency with a greater prevalence and incidence of urinary incontinence. However, little is known about the effect of vitamin D supplementation in reducing urinary incontinence. OBJECTIVE: This study aimed to evaluate the effects of vitamin D supplementation in reducing the frequency of urinary incontinence in older women. STUDY DESIGN: We conducted an ancillary study of women aged ≥55 years in the Vitamin D and Omega-3 Trial, a randomized trial with a 2×2 factorial design. Recruitment of participants started from 2011 to 2014 across 50 US states, and the follow-up of participants ended in January 2018. Randomized treatments in the parent study included (1) vitamin D3 (cholecalciferol) at a dosage of 2000 IU/d, (2) marine omega-3 fatty acids at a dosage of 1 g/d, and (3) matching placebo. Here, we analyzed women according to their randomization to vitamin D supplementation or placebo, regardless of treatment with omega-3 fatty acid supplementation. Validated frequency of urinary incontinence questions were added in year 2 of the study and were used again in year 5 at the end of trial. Prespecified ancillary outcomes included the prevalence of urinary incontinence at years 2 and 5, along with incident incontinence and progression of incontinence (from lower to higher frequency) from year 2 to year 5. Preplanned subgroup analyses examined the following outcomes: prerandomization of low serum levels of vitamin D (serum 25-hydroxyvitamin D<20 ng/mL), incontinence types, weight categories, and African American race. RESULTS: Among the randomized women who provided urinary incontinence data, 11,646 women at year 2 and 10,527 women at year 5, the mean age was 70 years at year 2, with 29% racial and ethnic minorities. The prevalence of urinary incontinence that occurred at least weekly was 29% at year 2 and increased to 37% at year 5. Vitamin D supplementation compared to with placebo was not associated with lower odds of urinary incontinence occurring at least weekly at year 2 (odds ratio, 1.08; 95% confidence interval, 0.99-1.19) or year 5 (odds ratio, 1.04; 95% confidence interval, 0.94-1.15). Vitamin D supplementation compared to placebo was not associated with lower incidence or progression of urinary incontinence from year 2 to year 5: incidence (odds ratio, 1.06; 95% confidence interval, 0.83-1.35) or progression (odds ratio, 0.94; 95% confidence interval, 0.82-1.08). Women with prerandomization of low serum levels of vitamin D (n=836) did not have lower odds of the prevalence, incidence, or progression of urinary incontinence. The findings were null in subgroups according to incontinence type, women with obesity, and African American women. Only women with healthy weight randomized to vitamin D had lower odds of progression of urinary incontinence (odds ratio, 0.78; 95% confidence interval, 0.63-0.95; P=.01). CONCLUSION: Vitamin D supplementation compared to placebo for 2 to 5 years was not associated with differences in the prevalence, incidence, or progression of urinary incontinence in older women with and without adequate serum vitamin D levels, with inconsistent differences among subgroups. The findings showed that the broad use of moderate doses of vitamin D supplementation did not reduce urinary incontinence in older women.

Considerations for integrated cognitive behavioural treatment for older adults with coexisting nocturia and insomnia.

Nocturia and chronic insomnia disorder are common conditions that frequently coexist in older adults. Existing medication treatments for each condition have risks, particularly in older adults. While treatment guidelines recommend starting with behavioural therapy for each condition, no existing program simultaneously addresses nocturia and insomnia. Existing behavioural interventions for nocturia or insomnia contain concordant and discordant components. An expert panel (including geriatricians with sleep or nocturia research expertise, sleep psychologists and a behavioural psychologist) was convened to combine and reconcile elements of behavioural treatment for each condition. Concordant treatment recommendations involve using situational self-management strategies such as urge suppression or techniques to influence homeostatic drive for sleep. Fluid modification such as avoiding alcohol and evening caffeine and regular self-monitoring through a daily diary is also appropriate for both conditions. The expert panel resolved discordant recommendations by eliminating overnight completion of voiding diaries (which can interfere with sleep) and discouraging routine overnight voiding (a stimulus control strategy). The final product is an integrated cognitive behavioural treatment that is delivered by advanced practice providers weekly over 5 weeks. This integrated program addresses the common scenario of coexisting nocturia and chronic insomnia disorder.

Early Life Sexual Trauma and Later Life Genitourinary Dysfunction and Functional Disability in Women.

BACKGROUND: Past research has examined the health outcomes of early sexual trauma in reproductive age women, but little is known about potential long-term effects in older age. OBJECTIVE: To examine associations between early life sexual trauma and later life sexual/genitourinary dysfunction and general functional disability in women. DESIGN: Cross-sectional analysis of nationally representative observational data from the National Social Life, Health, and Aging Project (2010-2011) PARTICIPANTS: One thousand seven hundred forty-five US women aged ≥ 50 years MAIN MEASURES: Two forms of early life sexual trauma (childhood sexual abuse and unwanted first sexual experience), sexual/genitourinary dysfunction (pain during sex, lack of pleasure during sex, urinary incontinence, other urinary symptoms), and general functional disability (difficulty performing 7 activities of daily living (ADLs) or 8 instrumental activities of daily living (IADLs)), assessed by interview and questionnaire. KEY RESULTS: Of 1745 women, 11% reported a history of childhood sexual abuse and 39% an unwanted first sexual experience. Childhood sexual abuse was associated with later life sexual/genitourinary dysfunction (pain during sex [OR 1.9, 95% CI 1.1-3.3], other urinary problems [OR 1.9, 95% CI 1.2-3.1]), and difficulty with multiple ADLs/IADLs (walking across the room [OR 1.9, 95% CI 1.2-3.1], getting in or out of bed [OR 2.0, 95% CI 1.2-3.3], bathing [OR 2.0, 95% CI 1.2-3.5], prepping meals [OR 2.4, 95% CI 1.5-3.8], shopping for food [OR 1.6, 95% CI 1.0-2.4], and completing light work [OR 1.6, 95% CI 1.0-2.4]), after adjusting for age, race, and education. Unwanted first sexual experience was associated with later life lack of pleasure with sex (OR 1.7, 95% CI 1.1-2.5) and difficulty with ADLs/IADLs (walking one block [OR 1.5, 95% CI 1.1-2.1], completing light work [OR 1.6, 95% CI 1.1-2.1]) in adjusted analyses. CONCLUSIONS: Early sexual trauma may be an under-recognized marker of risk of aging-related functional decline in women. Findings underline the importance of providing trauma-informed care for women across the aging spectrum.

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.

Patient-centered change in the day-to-day impact of postmenopausal vaginal symptoms: results from a multicenter randomized trial.

BACKGROUND: Vulvovaginal symptoms, which include dryness, irritation, and pain with intercourse, are common among postmenopausal women and are associated with impaired sexual functioning and quality of life. Previous assessment of treatment strategies for these symptoms has been limited by a lack of sensitive patient-centered outcome measures that assess symptom impact on functional and quality-of-life domains. OBJECTIVE: We aimed to (1) examine change in the impact of postmenopausal vulvovaginal symptoms on multiple aspects of well-being and functioning in relation to vaginal estradiol and moisturizer treatment and (2) guide meaningful interpretation of scores on a structured-item questionnaire measure of condition-specific impact. STUDY DESIGN: Data were drawn from postmenopausal women who were enrolled in the Menopause Strategies: Finding Lasting Answers for Symptoms and Health Vaginal Health Trial (a 12-week, double-blind, placebo-controlled randomized trial of treatment for vulvovaginal symptoms) who were assigned to vaginal 10-µg estradiol tablet plus placebo gel (n=98), vaginal moisturizer plus placebo tablet (n=97), or dual placebo (n=94). At baseline and 12-week follow up, participants completed the Day-to-Day Impact of Vaginal Aging questionnaire to assess the impact of vaginal symptoms on 4 domains (activities of daily living, emotional well-being, sexual functioning, and body image), each on a 0-4 point scale. Day-to-Day Impact of Vaginal Aging sensitivity to change was assessed by the examination of the associations between change in Day-to-Day Impact of Vaginal Aging domain scores and vulvovaginal symptom severity from baseline to 12 weeks with analysis of covariance. Within-woman and between-group minimal clinically important improvement was assessed with the use of an anchor-based approach that relates change in Day-to-Day Impact of Vaginal Aging domain scores with self-reported benefit from treatment. RESULTS: Participants in all treatment arms (n=289) demonstrated reduced impact of vulvovaginal symptoms on all domains of well-being and functioning as assessed by Day-to-Day Impact of Vaginal Aging at 12-week follow up, with no significant differences in improvement between women who were assigned to either estradiol tablet or vaginal moisturizer compared with placebo. For all Day-to-Day Impact of Vaginal Aging domains, mean impact scores were reduced when participants reported symptom improvement (-0.3 to -0.8 point change in Day-to-Day Impact of Vaginal Aging scores for <2-point symptom severity change vs -0.4 to -1.6 point change in Day-to-Day Impact of Vaginal Aging scores for 2+ point symptom severity change; all P<.001). Minimal clinically important change in Day-to-Day Impact of Vaginal Aging domain scale scores, which are anchored to self-reported meaningful benefit from treatment at 12 weeks, ranged from -0.4 to -1.3 (within-woman) and -0.2 to -0.7 (between-group). Observed change and minimal clinically important difference were largest for the sexual functioning domain. CONCLUSION: The impact of vulvovaginal symptoms on day-to-day activities, sexual function, emotional well-being, and body image may be improved with low-dose vaginal estradiol, moisturizer, or topical placebo. The Day-to-Day Impact of Vaginal Aging questionnaire demonstrates sensitivity to change with treatment of vulvovaginal symptoms, particularly Day-to-Day Impact of Vaginal Aging scales that focus on symptom impact on sexual functioning and body image. Minimal clinically important improvement in the impact of vulvovaginal symptoms as measured by the Day-to-Day Impact of Vaginal Aging can be defined with the use of these measures.

Convergent-Divergent Validity and Correlates of the Day-to-Day Impact of Vaginal Aging Domain Scales in the MsFLASH Vaginal Health Trial.

INTRODUCTION: Clinical research and management of postmenopausal vaginal symptoms have been limited by the lack of validated measures for assessing symptom impact. AIM: To evaluate convergent-divergent validity of the Day-to-Day Impact of Vaginal Aging (DIVA) questionnaire among postmenopausal women with moderate-to-severe vulvovaginal symptoms and identify demographic and clinical factors associated with greater symptom impact. METHODS: We examined baseline data from postmenopausal women with moderate-to-severe vulvovaginal itching, pain, irritation, dryness, or pain with intercourse in a randomized trial of vaginal estradiol, moisturizer, or placebo. In addition to completing the DIVA questionnaire, participants rated the severity of their most bothersome vulvovaginal symptom, underwent assessment of vaginal pH and epithelial cytology, and completed other self-report measures including the Female Sexual Function Index (FSFI), Female Sexual Distress Scale (FSDS), and Patient Health Questionnaire-8 for depression (PHQ-8). MAIN OUTCOME MEASURE: The main outcome measures were the unadjusted correlations and multivariable-adjusted associations with 4 DIVA domain scales designed to assess symptom impact on day-to-day activities, sexual functioning, emotional well-being, and body image/self-concept on a scale of 0 to 4. RESULTS: Among 301 women, we detected moderately strong correlations between the DIVA emotional well-being scale and PHQ-8 scores (Pearson correlation coefficient [r] = 0.39) and strong correlations between the DIVA sexual functioning scale and FSFI and FSDS scores (r > 0.50). No significant correlations were detected between any DIVA scales and vaginal pH or epithelial cytology. In adjusted linear-regression analyses, greater vulvovaginal symptom severity was associated with worse DIVA scores for emotional well-being, sexual functioning, and self-concept/body image (average 0.3- to 0.5-point higher DIVA score for each 1-point difference in vulvovaginal symptom severity). Depression symptoms were associated with worse DIVA scores for activities of daily living and emotional well-being (0.2- to 0.4-point higher DIVA score for each 5- point worsening of PHQ-8 score). Women reporting recent sexual activity had lower symptom impact on sexual functioning and self-concept/body image domains (-0.3- to -0.4-point lower DIVA score with weekly sexual activity). CLINICAL IMPLICATIONS: Findings suggest that the impact of postmenopausal vaginal symptoms on functioning and well-being is greater in women with co-morbid depression symptoms and less frequent sexual activity, independent of symptom severity. STRENGTHS & LIMITATIONS: Strengths include the multicenter sample and wide array of measures. Results may not generalize to women with mild symptoms. CONCLUSION: Our results support the construct validity of the DIVA questionnaire for clinical practice and research and indicate that depression and lower frequency of sexual activity are markers of greater impact of postmenopausal vaginal symptoms on multiple dimensions of functioning and quality of life. Hunter MM, Guthrie KA, Larson JC, et al. Convergent-Divergent Validity and Correlates of the Day-to-Day Impact of Vaginal Aging Domain Scales in the MsFLASH Vaginal Health Trial. J Sex Med 2020;17:117-125.

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.

Urinary Incontinence and Nocturia in Older Men: Associations with Body Mass, Composition and Strength in the Health ABC Study.

PURPOSE: In younger men lower body mass is associated with fewer urinary symptoms, including incontinence and nocturia. However, lower body mass may have different implications in older men due to age associated muscle atrophy and decreased strength. MATERIALS AND METHODS: We performed a prospective analysis of community dwelling men 70 to 79 years old in the multicenter Health ABC (Aging and Body Composition) study who underwent measurement of body mass on physical examination, composition using dual x-ray absorptiometry and strength according to grip and lower leg dynamometry. We evaluated associations with prevalent incontinence and nocturia on structured questionnaires as well as concurrent changes in urinary symptoms during 3 years using multivariate logistic regression. RESULTS: Of the 1,298 men analyzed 22% reported incontinence and 52% reported nocturia at baseline. Higher body mass index, fat mass and lower appendicular lean mass, and grip and quadriceps strength corrected for body mass index were associated with an increased prevalence of incontinence (each p <0.05). Higher body mass index and greater fat mass were also associated with an increased nocturia prevalence (each p <0.05). Concurrent 5% or greater decrease in body mass or fat mass was not associated with lower odds of new or worsening incontinence or nocturia, whereas a 5% or greater decrease in maximum grip strength was associated with higher odds of new or worsening incontinence. CONCLUSIONS: Older men with a higher body mass index and greater fat mass are more likely to report prevalent incontinence and nocturia. However, late life decreases in strength but not increases in body mass or fat mass were associated with a concurrent increase in urinary incontinence.