Behavioral Treatment of Overactive Bladder in Men

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: US Department of Veterans Affairs; VA Office of Research and Development
• Treatments: Mandelic Acids; Oxybutynin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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