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Oxybutynin transdermal system improves the quality of life in adults with overactive bladder: a multicentre, community‐based, randomized study
Author(s) -
Sand Peter,
Zinner Norman,
Newman Diane,
Lucente Vincent,
Dmochowski Roger,
Kelleher Con,
Dahl Naomi V.
Publication year - 2007
Publication title -
bju international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.773
H-Index - 148
eISSN - 1464-410X
pISSN - 1464-4096
DOI - 10.1111/j.1464-410x.2006.06658.x
Subject(s) - medicine , overactive bladder , oxybutynin , urinary incontinence , anticholinergic , quality of life (healthcare) , adverse effect , solifenacin , urology , randomized controlled trial , alternative medicine , nursing , pathology
OBJECTIVE To assess health‐related quality‐of‐life (HRQoL) and safety with the oxybutynin transdermal system (OXY‐TDS) (Oxytrol ® , Watson Pharma, Corona, CA, USA) in the M ulticentre A ssessment of Tr ansdermal Therapy i n Overactive Bladder With O x ybutynin (MATRIX) study, as HRQoL measurements are increasingly important in evaluating pharmacotherapy for overactive bladder (OAB). PATIENTS AND METHODS This randomized, open‐label, community‐based study enrolled 2878 participants aged ≥18 years who had been given a diagnosis of OAB. The 327 study sites were representative of various practice types. All participants were treated with OXY‐TDS 3.9 mg/day for ≤6 months. HRQoL was assessed using the King’s Health Questionnaire (KHQ); the primary endpoint was the change in KHQ scores from baseline to study end. RESULTS Most enrolees (2052/2625; 78.2%) had moderate to severe OAB at baseline (Patient Perception of Bladder Condition score ≥ 4 on a scale of 1–6), and most (1632/2859; 57.1%) had been given previous drug treatment for OAB. Of 2592 with evaluable baseline KHQ scores, 92.2% reported urgency and 88.2% reported urge urinary incontinence. The most impaired domains at baseline were Incontinence Impact (69.3), Symptom Severity (55.9), and Sleep/Energy (54.2). There were clinically meaningful and statistically significant improvements in nine of 10 domains at the study end; the greatest improvements were in Incontinence Impact (−13.5), Symptom Severity (−12.4), and Role Limitations (−13.3). The treatment was well tolerated, with low incidences of drug‐related anticholinergic adverse effects such as dry mouth (75; 2.6%), constipation (44; 1.5%), and dizziness (21; 0.7%). There were drug‐related application‐site reactions, including pruritus, erythema, dermatitis and irritation, in 14.0% of participants. CONCLUSIONS OXY‐TDS treatment was well tolerated in this diverse, community‐based population, and resulted in clinically significant improvements in HRQoL, regardless of baseline characteristics.