Coexisting nocturia and insomnia in older adults: Planning a trial of integrated therapy

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Nocturia occurs in nearly 50% of older adults and chronic insomnia disorder occurs in up to one-third of older adults. These two conditions frequently coexist in the same individual and contribute to sleep disturbance. As a geriatric syndrome, the causes of sleep disturbance are multifactorial and some risk factors and health conditions act synergistically to increase the risk within a single individual. Yet treatments for either nocturia or insomnia typically focus on an individual condition (e.g., nocturia) without addressing the other condition (e.g., insomnia). Given the synergism of these two conditions, an integrated treatment that addresses both nocturia and insomnia simultaneously has the potential to yield significant improvements in each condition and overall sleep. Recent evidence supports a future trial of integrated treatment for nocturia and insomnia disorder, particularly one that employs non-pharmacologic, non-surgical strategies. Studies find that behavioral treatment for nocturia improves insomnia symptoms and sleep quality. Similarly, behavioral treatments for insomnia reduce nocturia frequency and bother. In our recently piloted multicomponent behavioral intervention, which incorporated both sleep-related (i.e., sleep hygiene) and nocturia (e.g., pelvic floor muscle exercise- based urge suppression at night) treatments, the intervention reduced nocturia frequency equal to or better than drug therapy. The proposed integrated treatment addresses the bidirectional relationship between nocturia and insomnia. Wakefulness at night increases the opportunity for individuals to sense the urge to void. Nocturia also contributes to awakenings, difficulty returning to sleep, and excessive time in bed, which worsens insomnia and increases the opportunity to sense the urge to void. Our pilot study results suggest that a full- scale, comparative-effectiveness trial is needed to test this promising treatment. The objective of this R34 application is to plan for a future multi-site clinical trial that will test a novel, integrated non-pharmacologic (behavioral, cognitive, and lifestyle) treatment for coexisting nocturia and insomnia in an older adult population. The core components of this 5-week treatment (delivered by advanced practice providers such as nurse practitioners) will include education about the two conditions and their interactions, behavioral conditioning exercises for both conditions, relaxation exercises for both conditions, sleep restriction (a core component of cognitive behavioral therapy for insomnia), pelvic floor muscle training, lifestyle habits management, cognitive restructuring, and coping techniques. A full-scale, multisite trial is needed to determine the efficacy of the integrated program in improving sleep and nocturia outcomes with adequate power and with generalizability across multiple sites. In this application we propose the planning activities (developing, refining, and testing) of the protocol and procedures for a future full-scale trial conducted at multiple sites. The research team, which includes established investigators with expertise in urinary symptoms, sleep disorders, clinical trials, and health services research, has been collaborating to advance the field of nocturia-insomnia research.