Pilot Results from a Randomized Trial in Men Comparing Alpha-Adrenergic Antagonist versus Behavior and Exercise for Nocturia and Sleep

Abstract Purpose Nocturia and sleep problems are common in older adults. We developed and tested a novel intervention, multicomponent behavioral treatment and exercise therapy (M-BET), that may reduce nocturia and improve sleep in men. We compared reductions in nocturia and improvement in sleep in men with M-BET versus an active drug comparator (α-blocker) used alone or in combination (M-BET + α-blocker) Methods This randomized, controlled trial was conducted in the ambulatory setting in 2 US Department of Veterans Affairs medical centers in men at least 40 years of age with nocturia (defined as ≥2 nightly episodes). Participants were randomized to receive either M-BET, including pelvic floor muscle training, urge-suppression techniques, delayed voiding, fluid management, sleep hygiene, and peripheral edema management; an active comparator of known efficacy (the α-blocker tamsulosin, one 0.4-mg tablet nightly); or both therapies combined. Participants received interventions over 12 weeks. Outcomes were assessed via voiding diaries, wrist actigraphy, and validated questionnaires. The primary outcome was change in diary-recorded nocturia, assessed using ANCOVA for the between-group changes and paired t tests for within-group changes. Findings A total of 72 men with a mean age of 65.8 years participated. At 12 weeks, mean diary-recorded nocturia changed with M-BET by –1.39 episodes/night ( P < 0.001), with α-blocker therapy by –0.59 episodes/night ( P < 0.01), and with combination therapy by –1.03 episodes/night ( P < 0.01). Reductions were not statistically different across treatment groups ( P = 0.41). M-BET also showed statistically significant improvements in sleep quality, bother from nocturia, and nocturia-specific quality of life. All treatment groups indicated global satisfaction with treatment. Implications Behavioral therapy in men, alone or combined with α-blocker therapy, consistently showed large and statistically significant nocturia reductions and favorable effects on sleep and quality of life. Based on these findings, behavioral therapy, while not statistically superior to α-blocker therapy, may provide a meaningful treatment option for men with nocturia. Future research should include the development of behavioral treatment and exercise therapy interventions that could be more easily deployed. ClinicalTrials.gov identifier: NCT00824200.