Efficacy and Safety of OROS Oybutynin and TTS Oxybutynin in Middle-Aged and Elderly Women With Urinary Incontinence

Urinary Incontinence Clinical Trial

Official title: Efficacy and Safety of OROS® Oxybutynin and TTS Oxybutynin in Middle-Aged and Elderly Women With Urinary Incontinence

Status Completed

Clinical Trial Summary

The purpose of this study is to compare the side-effect profile and efficacy of sustained release, OROS® and TTS, dosage forms of oxybutynin with immediate release (IR) oral oxybutynin and with placebo.

Clinical Trial Description

Urinary incontinence (UI) refers to the involuntary loss of urine in sufficient amounts to be considered a social or health problem. While it is a psychologically distressing and socially disruptive, UI is believed to be an under reported and under diagnosed medical condition. This is a Multicenter, randomized, double-blind, placebo-controlled, parallel group study with 1 week of single-blinded placebo run-in. Patients will be randomized to 6 weeks double-blind treatment with oxybutynin or placebo. The primary hypothesis to be tested in this study is that the treatment difference in the change in incontinence episodes per week after 6 weeks of treatment in the double-blind phase between individual oxybutynin-treated group and combined placebo group is equal to zero.

The patients will receive oral OROS® containing oxybutynin, immediate release oral oxybutynin (1.7 or 2.5 mg) or TTS oxybutynin (60 cm2) daily for 7 weeks. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urinary Incontinence

• NCT number: NCT00304499
• Study type: Interventional
• Source: Alza Corporation, DE, USA
• Status: Completed
• Phase: Phase 3
• Start date: December 1995
• Completion date: December 1996