Roger Dmochowski, MD, Department of Urology, Vanderbilt University, Robert Parker, MD, Lyndhurst Gynecologic Associates, Winston-Salem, NC and Rita Melkonian, MD, Private practice, San Francisco, CA (Presented By: Roger Dmochowski, MD, Department of Urology, Vanderbilt University)

Introduction and Objectives: Overactive bladder (OAB) has a negative impact on health-related quality of life (HRQOL). The Multicenter Assessment of Transdermal Therapy in Overactive Bladder With Oxybutynin (MATRIX) study was conducted to determine the effects of treatment with transdermal oxybutynin (OXY-TDS) on HRQOL and other measures for individuals with OAB. This analysis examines the relationship between prior treatment for OAB and HRQOL outcomes.

Methods: MATRIX was an open-label, multicenter, community-based, prospective study in adults with symptoms of OAB. Participants were stratified into 3 categories by prior OAB therapy: never treated (naïve), treatment stopped <30 days before enrollment (recently treated), or treatment stopped ≥30 days before enrollment (lapsed). All participants in the study received OXY-TDS at the US Food and Drug Administration (FDA)-approved dosage of 3.9 mg/day (2 patches per week) for up to 6 months. HRQOL impairment was assessed with King’s Health Questionnaire^® (KHQ) at baseline, 3 months, and 6 months. Satisfaction with OXY-TDS was assessed via monthly telephone interviews. The primary end point was change from baseline to end of study in KHQ domain scores for the intent to treat (ITT) population, comprising participants who received ≥2 doses and had ≥1 postbaseline assessment. P values were derived from analysis of covariance (ANCOVA) (last observations carried forward) and a 1-sample, 2-tailed t test. Funding support was provided by Watson Laboratories.

Results:  Of 2878 enrolled participants, 12.8% were men and 83.6% were Caucasian; mean age was 62.5±14.8 years (range, 18–100 y). Most participants (57.1%) had been treated previously for OAB; of these, 31.6% had received multiple medications. The most common prior medications were extended-release tolterodine (31.0%) and extended-release oxybutynin (18.2%). In the intent-to-treat (ITT) population (n=2593), 42.5% of participants were naïve, 33.5% were recently treated, and 24.0% were lapsed; participants in the 3 groups had significantly (P≤.0033) different baseline scores in 7 of 10 KHQ domains, with naïve participants having a higher HRQOL than those who were recently treated or lapsed. The study population as a whole showed significant improvement in all domains of the KHQ at end of study (P<.0001), except General Health Perception. Although all subgroups experienced clinically meaningful improvement in ≥7 of 10 domains, significant differences in response magnitude were seen between groups in 6 of 10 domains. Most participants (63.4%) previously treated for OAB reported greater satisfaction with OXY-TDS therapy, relative to their prior medications. This is comparable with the overall satisfaction rate in the entire study population, in which 69% of participants reported that they were “very satisfied” or “satisfied” with OXY-TDS.

UroToday.com Coverage of SUFU 2007

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