Effects of Oxybutynin Chloride Topical Gel on Health-Related Quality of Life in Adults with Overactive Bladder: A Randomized, Double-Blind, Placebo-Controlled Study

Objective: Oxybutynin chloride topical gel (OTG) significantly improved overactive bladder (OAB)-related urinary symptoms and was well tolerated in a phase III double-blind, placebo-controlled trial (ClinicalTrials.gov identifier NCT00350636). This study further evaluated the effect of OTG on health-related quality of life (HRQoL) in adults with OAB. Methods: Adults aged 18 years or older with urge-predominant urinary incontinence were assigned randomly to OTG 1 g/day or matching placebo for 12 weeks. HRQoL was measured by the Incontinence Impact Questionnaire (IIQ) and the King's Health Questionnaire (KHQ) at baseline and at weeks 1, 4, 8, and 12. Between-group differences in IIQ or KHQ score changes from baseline to week 12 or last observation were compared by analysis of covariance. Results: Of 789 study participants (704 women, 85 men), 389 received OTG and 400 received placebo. Mean age was 59 +/- 12 years. IIQ total score improved significantly more in participants treated with OTG (P = 0.0005) than in those treated with placebo, as did scores on all four IIQ subscales: Emotional Health (P = 0.0002), Social Relationships (P = 0.0019), Travel (P = 0.0068), and Physical Activity (P = 0.0078). KHQ scores improved significantly more with OTG than with placebo in the more incontinence-specific domains: Incontinence Impact (P = 0.0023), Symptom Severity (P = 0.0024), Severity (Coping) Measures (P = 0.0058), Sleep/Energy (P = 0.0061), Role Limitations (P = 0.0133), and Personal Relationships (P = 0.0489). Conclusion: Treatment with OTG resulted in significant HRQoL improvements in adults with OAB.