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

• Published in: Clinical therapeutics 2016-11, Vol.38 (11), p.2394-2406.e3
• Main Authors: Johnson, Theodore M., MD, MPH, Vaughan, Camille P., MD, MS, Goode, Patricia S., MSN, MD, Bliwise, Donald L., PhD, Markland, Alayne D., DO, MSc, Huisingh, Carrie, MPH, Redden, David T., PhD, McGwin, Gerald, Jr, MS, PhD, Eisenstein, Rina, MD, Ouslander, Joseph G., MD, Issa, Muta, MD, MBA, Burgio, Kathryn L., PhD
• Format: Article
• Language: English
• Subjects: Behavior modification; Bladder; Diabetes; Diaries; Drug dosages; Drug therapy; Heart failure; Internal Medicine; Medical Education; Mortality; Older people; Pain; Quality; Sleep
• ISSN: 0149-2918; 1879-114X
• DOI: 10.1016/j.clinthera.2016.10.001

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.