INTRODUCTION: Incontinence is a bothersome symptom in patients with overactive bladder (OAB) and a main symptom for help-seeking behavior. Our analysis of three phase III studies aimed to assess the effect of darifenacin on the number of Dry Days and incontinence episodes (IEs) in participants with OAB with incontinence.
METHODS: Pooled data from three randomized, placebo-controlled, fixed-dose studies (n=1059) were analyzed. Participants with OAB received 12 weeks' treatment with once daily darifenacin 7.5 mg (n=337) or 15 mg (n=334) or placebo (n=388). The number of participants achieving ≥ 3 consecutive Dry Days was the primary analysis endpoint. Health-related quality of life (HRQoL) was assessed using the King's Health Questionnaire (KHQ).
RESULTS: Significantly more participants taking daridenacin at week 12 achieved ≥ 3 consecutive Dry Days versus placebo (52.6% versus 39.8%, respectively; P ≤ .001). Significant improvements were observed in participants with mild (< 14 IEs/week) and moderate/severe (≥ 14 IEs/week) OAB with incontinence. Participants with ≥ 3 consecutive Dry Days had statistically significantly greater improvements in IEs, IEs resulting in a change of pads/clothing, micturitions/day, episodes of urgency and KHQ scores, compared with those who did not achieve ≥ 3 consecutive Dry Days. Darifenacin was well tolerated.
CONCLUSIONS: Darifenacin treatment significantly increased the number of participants achieving ≥ 3 consecutive Dry Days and significantly reduced the number of IEs. Similar improvements were observed with long-term treatment and were associated with significant improvements in HRQoL. These findings indicate that darifenacin is an effective treatment for participants with 'wet' OAB.
Diane Newman,1 William S Aronstein,2 Yodit Seifu,3 Andrea Larson-Peters,4 Lidia Mongay3
1 Division of Urology, University of Pennsylvania, Philadelphia, PA, USA
2 CTI Clinical Trial and Consulting Services, Cincinnati, OH, USA
3 Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA,
4 Procter & Gamble, Cincinnati, OH, USA
Submitted August 2, 2010 - Accepted for Publication October 27, 2010
KEYWORDS: Antimuscarinic agents; Darifenacin; Overactive bladder; Urinary incontinence.
CORRESPONDENCE: Diane Newman, Co-Director, Penn Center for Continence and Pelvic Health, Director, Clinical Trials, Division of Urology, University of Pennsylvania Medical Center, 9 Penn Tower, 34th & Civic Center Blvd, Philadelphia, Pennsylvania 19104, USA (
CITATION: UroToday Int J. 2010 Dec;3(6). doi:10.3834/uij.1944-5784.2010.12.11
ABBREVIATIONS AND ACRONYMS: AE, adverse event; IE, incontinence episode; HRQoL, health-related quality of life; KHQ, King's Health Questionnaire; LOCF, last-observation-carried-forward;OAB, overactive bladder.