Status:
COMPLETED
Behavioral Treatment of Overactive Bladder in Men
Lead Sponsor:
US Department of Veterans Affairs
Conditions:
Overactive Bladder
Eligibility:
MALE
19+ years
Phase:
PHASE3
Brief Summary
The primary purpose of this project is to evaluate the effectiveness of behavioral treatment compared to standard drug therapy for symptoms of OAB in male veterans.
Detailed Description
Overactive bladder (OAB) is a very common and bothersome condition manifested by urgency, frequent urination, urge urinary incontinence, and nocturia. Drug therapy with oxybutynin or tolterodine is th...
Eligibility Criteria
Inclusion
- Male
- Community-dwelling
- Veteran
- Self-reported urgency
- Self-reported frequent urination
- Mean of \> 8 voids per 24-hour day on bladder diary
- Able to come to clinic
Exclusion
- Urologic surgery in the past 6 months
- Nonambulatory (unless has independent transfer skills)
- Flow rate \< 5mL at baseline and \< 10mL/sec after run-in (on simple uroflowmetry)
- Post-void residual urine volume \> 250mL at baseline and \> 150mL after run-in (on bladder ultrasound)
- Continual leakage
- Urinary tract infection (growth of \> 100,000 colonies per ml of a urinary pathogen on urine culture). May be reconsidered after treatment and negative culture.
- Fecal impaction
- Poorly controlled diabetes (glycosylated hemoglobin \>9 within last 3 months)
- Hematuria on microscopic examination in the absence of infection
- Any unstable medical condition (particularly: decompensated congestive heart failure, malignant arrhythmias, unstable angina)
- \-- Impaired mental status (\< 24 on Folstein's Mini-Mental State Exam)
- Narrow angle glaucoma
- Gastric retention (by medical history)
- Hypersensitivity to tamsulosin or oxybutynin
- Current use of anticholinergic agents for detrusor instability. May be reconsidered after 2-week wash-out.
- If on diuretic, dose has not been stable for at least three months
- Sleep apnea, unless surgically corrected
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
143 Patients enrolled
Trial Details
Trial ID
NCT01187498
Start Date
January 1 2005
End Date
October 1 2009
Last Update
May 20 2014
Active Locations (2)
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1
Birmingham VA Medical Center
Birmingham, Alabama, United States, 35233
2
Atlanta VA Medical and Rehab Center, Decatur
Decatur, Georgia, United States, 30033