Behavior and Exercise Versus Drug Treatment in Men With Nocturia (BEDTiMe)

Summary

Nocturia, waking at night from sleep to void, is a prevalent and troublesome symptom. Treatment with an alpha-adrenergic antagonist medication (α-blockers) is a standard therapy for LUTS in men, but α-blockers offer only limited reductions in nocturia. While combinations of multiple drugs could be used, many individuals wish to take fewer medications. Participants in the BEDTiMe Nocturia Study will undergo a series of visits during which they will receive a combination of either standard drug therapy (or placebo) and a behavioral intervention tailored to help with nocturia or problems with nocturia. Participants will be evaluated for outcomes at 12 weeks and followed for six months. This study will yield important information related to alternative treatments of nocturia in men, as well as novel information regarding the clinical importance of these nocturia reductions. This study has the potential to alter standards of care.

Timeline

Start

2008-07

Primary completion

2014-02

Completion

2014-03

Publications

• Results Johnson TM 2nd, Vaughan CP, Goode PS, Bliwise DL, Markland AD, Huisingh C, Redden DT, McGwin G, Eisenstein R, Ouslander JG, Issa M, Burgio KL. Pilot Results from a Randomized Trial in Men Comparing Alpha-Adrenergic Antagonist versus Behavior and Exercise for Nocturia and Sleep. Clin Ther. 2016 Oct 28:S0149-2918(16)30742-1. doi: 10.1016/j.clinthera.2016.10.001. Online ahead of print.

Drugs

Indications