Behavioral Treatment of Overactive Bladder in Men

Completed · Phase 3

Conditions studied: Overactive Bladder

In brief

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.

Key facts

Study ID

NCT01187498

Run by

US Department of Veterans Affairs

People needed

143

Starts

2005-01-01

Expected to finish

2009-10-01

Last updated by the study team

2014-05-20

Who can join

Age: 19 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Birmingham VA Medical Center — Birmingham, Alabama, United States
• Atlanta VA Medical and Rehab Center, Decatur — Decatur, Georgia, United States

Full record on ClinicalTrials.gov

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