Combined Behavioral and Drug Treatment of Overactive Bladder in Men — COBALT  

Overactive Bladder Clinical Trial

Official title: Combined Behavioral and Drug Treatment of Overactive Bladder in Men

Status Completed

Clinical Trial Summary

The primary aim of this project is to evaluate the effectiveness of combined behavioral + drug therapy compared to behavioral treatment alone and drug therapy alone as a way to improve outcomes in the treatment of OAB symptoms in men. We hypothesize that combined therapy will result in better outcomes than either behavioral or drug therapy alone. The second aim is to compare two methods of implementing combined therapy: simultaneously as initial therapy vs. stepped therapy, in which therapies are combined following initial behavioral or drug therapy alone. The third aim is to examine the costs and cost-effectiveness of combined behavioral + drug therapy compared to behavioral or drug therapy alone.

Clinical Trial Description

Overactive bladder (OAB) is a very common, distressing condition that manifests as bothersome symptoms of urgency, frequent urination, urge incontinence, and nocturia, and impacts the lives of millions of men. OAB symptoms are most often treated with pharmacologic therapies (alpha-blocking agents and/or antimuscarinic agents) or behavioral treatments. Although drug therapies (even combined drug therapies) and behavioral treatments reduce OAB symptoms, few patients are completely cured with either treatment alone. Therefore, there is a need to improve interventions for this common problem. The primary purpose of this study is to test the effectiveness of combining behavioral treatment and drug therapy as a way to improve outcomes in the treatment of OAB symptoms in men. This is a 3-site, 2-stage, 3-arm randomized clinical trial of behavioral treatment, drug therapy, and combined drug + behavioral therapy for men with OAB, to examine the efficacy of combined therapy and whether it yields higher success rates than either therapy alone. 201 men with OAB will be enrolled and randomized to 1)drug therapy alone followed by combined therapy, 2)behavioral treatment alone followed by combined therapy, or 3)combined therapy as initial treatment. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lower Urinary Tract Symptoms
• Overactive Bladder
• Urinary Bladder, Overactive

• NCT number: NCT01175382
• Study type: Interventional
• Source: University of Alabama at Birmingham
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: July 2010
• Completion date: July 2015