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

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: Male

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
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Atlanta VA Medical Center
• Collaborators: Emory University; University of Alabama at Birmingham
• Treatments: Adrenergic Agents; Adrenergic alpha-Antagonists; Adrenergic Antagonists; Tamsulosin

Criteria

Inclusion Criteria:

1. Nocturia ≥2 episodes / night average on the screening diary;

2. Willingness and appropriateness to receive an α- blocker;

3. Willingness to keep a bladder and sleep diary;

4. Willingness to wear a wrist actigraph; and

5. Willingness to make study visits

Exclusion Criteria:

1. Evidence of overt bladder outlet obstruction: peak uroflow <4 mL/sec on a void of ≥125 mL, or a PVR of ≥ 300 mL;

2. Use of clean intermittent self-catheterization at home or having been instructed by a provider to do so within the last 12 months;

3. Genitourinary cancer, including active prostate cancer with ongoing surgical or radiation treatment, or the need of treatment, or bladder cancer, or persistent unexplained hematuria;

4. Obstructive sleep apnea with CPAP use, provider diagnosis with symptoms, or strong suspicion of diagnosis during screening;

5. Having Parkinson's disease with an uncontrolled tremor (invalidates wrist actigraphy);

6. Poorly controlled congestive heart failure as evidenced on physical examination;

7. Poorly controlled diabetes mellitus with either hemoglobin A1c of ≥ 7.5 or a random glucose ≥ 200 within last 3 months; or

8. Unstable health conditions expected to result in death or hospitalization within 3 months, as assessed by PI or Site PI;

9. Previously receiving intensive bladder training;

10. Allergic to Tamsulosin;

11. Previous spinal cord injury;

12. Currently on dialysis or in consideration for dialysis due to end stage renal disease;

13. More than 2 urinary tract infections within the last 12 months;

14. Not able to transfer independently from a wheelchair to the toilet;

15. Unstable dose of diuretic within the past 3 months;

16. Has an artificial urinary sphincter;

17. Impaired mental status;

18. TURP or other urologic surgery within the last 6 months.