Behavior and Exercise Versus Drug Treatment in Men With Nocturia (BEDTiMe)
Status:
Completed
Trial end date:
2014-03-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
Atlanta VA Medical Center
Collaborators:
Emory University University of Alabama at Birmingham