Status:
COMPLETED
Behavior and Exercise Versus Drug Treatment in Men With Nocturia (BEDTiMe)
Lead Sponsor:
Atlanta VA Medical Center
Collaborating Sponsors:
Emory University
University of Alabama at Birmingham
Conditions:
Nocturia
Eligibility:
MALE
40+ years
Phase:
PHASE4
Brief 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...
Detailed Description
Nocturia, waking at night from sleep to void, is a prevalent and troublesome symptom. While other lower urinary tract symptoms (LUTS)-- including poor urinary stream, urgency, frequency, and straining...
Eligibility Criteria
Inclusion
- Nocturia ≥2 episodes / night average on the screening diary;
- Willingness and appropriateness to receive an α- blocker;
- Willingness to keep a bladder and sleep diary;
- Willingness to wear a wrist actigraph; and
- Willingness to make study visits
Exclusion
- Evidence of overt bladder outlet obstruction: peak uroflow \<4 mL/sec on a void of ≥125 mL, or a PVR of ≥ 300 mL;
- Use of clean intermittent self-catheterization at home or having been instructed by a provider to do so within the last 12 months;
- Genitourinary cancer, including active prostate cancer with ongoing surgical or radiation treatment, or the need of treatment, or bladder cancer, or persistent unexplained hematuria;
- Obstructive sleep apnea with CPAP use, provider diagnosis with symptoms, or strong suspicion of diagnosis during screening;
- Having Parkinson's disease with an uncontrolled tremor (invalidates wrist actigraphy);
- Poorly controlled congestive heart failure as evidenced on physical examination;
- Poorly controlled diabetes mellitus with either hemoglobin A1c of ≥ 7.5 or a random glucose ≥ 200 within last 3 months; or
- Unstable health conditions expected to result in death or hospitalization within 3 months, as assessed by PI or Site PI;
- Previously receiving intensive bladder training;
- Allergic to Tamsulosin;
- Previous spinal cord injury;
- Currently on dialysis or in consideration for dialysis due to end stage renal disease;
- More than 2 urinary tract infections within the last 12 months;
- Not able to transfer independently from a wheelchair to the toilet;
- Unstable dose of diuretic within the past 3 months;
- Has an artificial urinary sphincter;
- Impaired mental status;
- TURP or other urologic surgery within the last 6 months.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00824200
Start Date
July 1 2008
End Date
March 1 2014
Last Update
September 16 2021
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Birmingham VA Medical Center
Birmingham, Alabama, United States, 35233
2
Atlanta VA Medical Center
Atlanta, Georgia, United States, 30033