A multi-center trial to improve nocturia and sleep in older adults

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PROJECT SUMMARY Nocturia (waking to pass urine during the main sleep period) occurs two or more times per night in nearly 50% of older adults and is among the most bothersome urinary symptoms, due to its potentially severe impact on sleep. However, nocturia in older adults is often viewed solely as a urological condition even though it is also a sleep condition since it involves disturbances of the “main sleep period.” Bladder, prostate, and antidiuretic medications, fluid restriction, bladder training, and pelvic floor muscle exercises are often prescribed, but the effectiveness of all treatments is limited and medication side effects including delirium and falls are concerning in older adults. The long-term goal of this research is to develop a safe, cross-specialty treatment that will improve the lives of older adults with nocturia. One explanation for the high rates of nocturia despite available treatments is that current approaches overlook non-lower urinary tract factors that contribute to nighttime awakenings. For example, cognitive hyperarousal and decreased homeostatic sleep drive from daytime napping may increase the tendency to arouse and sense the urge to void; and maladaptive compensatory behaviors may lead to excessive time in bed, thereby increasing opportunity to sense the urge to void. Cognitive behavioral therapy for insomnia effectively reduces nighttime wakefulness and early evidence suggests it also reduces nocturia. Unfortunately, nocturia treatment crosses specialties, and delivering urological and sleep therapies in a coordinated manner is a treatment barrier. The overall objective of the proposed project is to determine whether a coordinated, integrated non- pharmacological, non-surgical treatment that simultaneously addresses both the urological and insomnia factors contributing to nocturia is efficacious for improving nocturia, sleep, and daytime function. Results from our NIA-supported R34 multisite planning grant demonstrate the feasibility of the novel Nocturia Insomnia Program-Integrated Treatment (NIP-IT) program, which integrates best practice behavioral treatment strategies for nocturia and cognitive behavioral therapy for insomnia components to reduce awakenings and urinary frequency during nighttime awakenings due to other reasons. The rationale for the proposed research is that addressing hyperarousal, conditioned responses, and maladaptive thoughts/behaviors and increasing homeostatic sleep drive are critical to reducing nocturia frequency and nighttime wakefulness and improving overall nocturia-related quality of life. We now propose a randomized trial (n=192) comparing NIP-IT to a health education control program in adults aged > 60 with nocturia and insomnia symptoms to provide rigorous, definitive evidence of the efficacy of the NIP-IT program to reduce both nocturia episodes and sleep disturbance. We will also assess impact on nocturia and sleep-related quality of life.