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NCT00824200 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study, sponsored by Atlanta VA Medical Center.

Completed
Registry status
Phase 4
Development phase
72
Enrollment target

NCT00824200: Completed Phase 4 study, sponsored by Atlanta VA Medical Center.

NCT00824200 is a Phase 4 study that has completed, run by Atlanta VA Medical Center. The registered enrollment target is 72 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00824200, a Phase 4 study, has completed, sponsored by Atlanta VA Medical Center.

COMPLETED
Registry status
Phase 4
Development phase
72 participants
Enrollment target

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.

Primary Outcome

Participant recorded bladder diary over 7-day that included nocturia episodes

Interventions

  • DRUG placebo
  • BEHAVIORAL Behavioral
  • BEHAVIORAL placebo
  • DRUG tamsulosin (alpha-adrenergic antagonist medication)

Trial Details

FieldValue
Enrollment Target 72 participants
Start Date 2008-07
Est. Completion 2014-03
Phase Phase 4
Atlanta VA Medical Center

12 total trials

What the finished NCT00824200 record still lists

NCT00824200 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower).

The record links to 0 conditions, and to 4 interventions - of which placebo is the first listed.

NCT00824200 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00824200 about?

NCT00824200 is a clinical study titled "Behavior and Exercise Versus Drug Treatment in Men With Nocturia (BEDTiMe)". 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 u...

What is the current status of trial NCT00824200?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 72 participants. The study started on 2008-07. Estimated completion is 2014-03.

What interventions are being tested in trial NCT00824200?

The interventions under investigation include: placebo (DRUG), Behavioral (BEHAVIORAL), placebo (BEHAVIORAL), tamsulosin (alpha-adrenergic antagonist medication) (DRUG).

Who is sponsoring clinical trial NCT00824200?

This trial is sponsored by Atlanta VA Medical Center, which has 12 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00824200's enrollment target sits among peer trials

72 1035th of 2000 higher than 961 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00824200, the US trial registry maintained by the National Library of Medicine. NCT00824200 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.