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

NCT00824200 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2021-09-16

No results posted yet for this study

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.

Conditions

  • Nocturia

Interventions

BEHAVIORAL

Behavioral

Multicomponent Behavioral and Exercise Therapy (M-BET) - pelvic floor muscle exercises, urge suppression strategies, fluid strategies, sleep hygiene \& non-pharmacological management of peripheral edema.

DRUG

tamsulosin (alpha-adrenergic antagonist medication)

0.4 mg given daily

DRUG

placebo

tamsulosin placebo

BEHAVIORAL

placebo

placebo behavioral intervention

Sponsors & Collaborators

  • Emory University

    collaborator OTHER

  • University of Alabama at Birmingham

    collaborator OTHER

  • Atlanta VA Medical Center

    lead FED

Principal Investigators

  • Theodore Johnson II, MD, MPH · Atlanta Veteran Affairs Adminstration, Emory University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
40 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2014-02-28
Completion
2014-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00824200 on ClinicalTrials.gov