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Pilot Results from a Randomized Trial in Men Comparing Alpha-Adrenergic Antagonist versus Behavior and Exercise for Nocturia and Sleep
Johnson TM et al.
Clinical Therapeutics, Volume 38, Issue 11, November 2016, Pages 2394–2406.e3
Commentary by Philip Van Kerrebroeck
These authors studied the effects of a 12 weeks multicomponent behavioral treatment andexercise therapy (M-BET) on nocturia and improve sleep in 72 men with a mean age of 65.8yearsd. They compared reductions in nocturia and improvement in sleep in men with M-BETversus an active drug comparator (α-blocker) used alone or in combination (M-BET + α-blocker). This is a well conducted randomized, controlled trial performed in the ambulatorysetting of two US Department of Veterans Affairs medical centers in men at least 40 years ofage with nocturia (defined as ≥2 nightly episodes). The M-BET included pelvic floor muscletraining, urge-suppression techniques, delayed voiding, fluid management, sleep hygiene,and peripheral edema management. As an active comparator the α-blocker tamsulosin, one0.4-mg tablet nightly was used. Outcomes were assessed via voiding diaries, wristactigraphy, and validated questionnaires. The primary outcome was change in diary-recorded nocturia, assessed using ANCOVA for the between-group changes and paired ttests for within-group changes. 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 notstatistically different across treatment groups (P = 0.41). However M-BET showedstatistically significant improvements in sleep quality, bother from nocturia, and nocturia-specific quality of life. The authors conclude that behavioral therapy, while not statisticallysuperior to α-blocker therapy, may provide a meaningful treatment option for men withnocturia. However they also indicate that future research should include the development ofbehavioral treatment and exercise therapy interventions that could be more easily deployed.