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 Multicentre Assessment of Transdermal Therapy in Overactive Bladder With Oxybutynin (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.
RCT Entities:
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 Multicentre Assessment of Transdermal Therapy in Overactive Bladder With Oxybutynin (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.
Authors: Roger R Dmochowski; Diane K Newman; Peter K Sand; Delbert C Rudy; Kim E Caramelli; Heather Thomas; Gary Hoel Journal: Clin Drug Investig Date: 2011 Impact factor: 2.859
Authors: Gary G Kay; David R Staskin; Scott MacDiarmid; Marilyn McIlwain; Naomi V Dahl Journal: Clin Drug Investig Date: 2012-10-01 Impact factor: 2.859