title: Pilot Results from a Randomized Trial in Men Comparing Alpha-Adrenergic Antagonist versus Behavior and Exercise for Nocturia and Sleep.
abstract: OBJECTIVE
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Birmingham/Atlanta Geriatric Research, Education, and Clinical Center (GRECC), Atlanta VAMC, Decatur, Georgia; Department of Medicine, Emory University, Atlanta, Georgia. Electronic address: tmjohns@emory.edu.
authors.forename: Theodore M
authors.initials: TM
authors.lastname: Johnson
authors.affiliation: Birmingham/Atlanta Geriatric Research, Education, and Clinical Center (GRECC), Atlanta VAMC, Decatur, Georgia; Department of Medicine, Emory University, Atlanta, Georgia.
authors.forename: Camille P
authors.initials: CP
authors.lastname: Vaughan
authors.affiliation: Birmingham/Atlanta GRECC, Birmingham VAMC, Birmingham, Alabama; Division of Gerontology, Geriatrics and Palliative Care, Department of Medicine, University of Alabama-Birmingham, Birmingham, Alabama.
authors.forename: Patricia S
authors.initials: PS
authors.lastname: Goode
authors.affiliation: Program in Sleep, Aging and Chronobiology, Department of Neurology, School of Medicine, Emory University, Atlanta, Georgia.
authors.forename: Donald L
authors.initials: DL
authors.lastname: Bliwise
authors.affiliation: Birmingham/Atlanta GRECC, Birmingham VAMC, Birmingham, Alabama; Division of Gerontology, Geriatrics and Palliative Care, Department of Medicine, University of Alabama-Birmingham, Birmingham, Alabama.
authors.forename: Alayne D
authors.initials: AD
authors.lastname: Markland
authors.affiliation: Departments of Epidemiology, Birmingham, Alabama.
authors.forename: Carrie
authors.initials: C
authors.lastname: Huisingh
authors.affiliation: Birmingham/Atlanta GRECC, Birmingham VAMC, Birmingham, Alabama; Biostatistics, School of Public Health, University of Alabama, Birmingham, Alabama.
authors.forename: David T
authors.initials: DT
authors.lastname: Redden
authors.affiliation: Birmingham/Atlanta GRECC, Birmingham VAMC, Birmingham, Alabama; Departments of Epidemiology, Birmingham, Alabama.
authors.forename: Gerald
authors.initials: G
authors.lastname: McGwin
authors.affiliation: Birmingham/Atlanta Geriatric Research, Education, and Clinical Center (GRECC), Atlanta VAMC, Decatur, Georgia; Department of Medicine, Emory University, Atlanta, Georgia.
authors.forename: Rina
authors.initials: R
authors.lastname: Eisenstein
authors.affiliation: Birmingham/Atlanta Geriatric Research, Education, and Clinical Center (GRECC), Atlanta VAMC, Decatur, Georgia; Department of Medicine, Emory University, Atlanta, Georgia.
authors.forename: Joseph G
authors.initials: JG
authors.lastname: Ouslander
authors.affiliation: Department of Urology, Atlanta Veterans Affairs Medical Center (VAMC), Decatur, Georgia.
authors.forename: Muta
authors.initials: M
authors.lastname: Issa
authors.affiliation: Birmingham/Atlanta GRECC, Birmingham VAMC, Birmingham, Alabama; Division of Gerontology, Geriatrics and Palliative Care, Department of Medicine, University of Alabama-Birmingham, Birmingham, Alabama.
authors.forename: Kathryn L
authors.initials: KL
authors.lastname: Burgio
keywords: behavioral treatment and exercise therapy; nocturia; sleep disorder; α-blocker