drugset / Trial / NCT01175382

Combined Behavioral and Drug Treatment of Overactive Bladder in Men

NCT01175382

Phase 2/3 Completed 204 enrolled University of Alabama at Birmingham
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2010-07
Primary completion
2015-07
Completion
2015-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Tamsulosin Other / unclassified 0.4 mg
Comparator Tolterodine Small molecule 4 mg

Indications