Efficacy and Safety of OROS Oybutynin and TTS Oxybutynin in Middle-Aged and Elderly Women With Urinary Incontinence
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
|Official Title:||Efficacy and Safety of OROS® Oxybutynin and TTS Oxybutynin in Middle-Aged and Elderly Women With Urinary Incontinence|
- The primary efficacy parameter is the mean change in urge incontinence episodes per week from baseline to last week after up to 6 weeks double-blind treatment.
- The secondary efficacy parameters are Mean incontinent episodes per week based on the Patient Urinary Diary (PUD); Mean diurnal and nocturnal micturition frequencies (PUD); Mean incontinence pads changed each day due to wetness (PUD).
|Study Start Date:||December 1995|
|Estimated Study Completion Date:||December 1996|
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.