Abstract
Purpose We evaluated the efficacy and safety of flexible dose fesoterodine in medically complex vulnerable elderly subjects with urgency urinary incontinence. Materials and Methods In this 12-week, randomized, double-blind, flexible dose, placebo controlled trial, subjects were community dwelling men and women 65 years old or older. Subjects had scores of 3 or more on the VES-13 (Vulnerable Elders Survey) and 20 or more on the MMSE (Mini-Mental State Examination), and 2 to 15 urgency urinary incontinence episodes and 8 or more micturitions per 24 hours on 3-day baseline diaries. Subjects randomized to fesoterodine received 4 mg once daily for 4 weeks and could then increase to 8 mg based on discussion with the investigator. Subjects receiving 8 mg could decrease the dose to 4 mg at any time (sham escalation and de-escalation for placebo). The primary outcome measure was change in daily urgency urinary incontinence episodes. Secondary outcomes included changes in other diary variables and patient reported quality of life measures. Safety evaluations included self-reported symptoms and post-void residual volume. Results A total of 562 patients were randomized (mean age 75 years, 50.4% age 75 years or greater). Subjects had high rates of comorbidities, polypharmacy and functional impairment. At week 12 the fesoterodine group had significantly greater improvements in urgency urinary incontinence episodes per 24 hours (-2.84 vs -2.20, p = 0.002) and most other diary variables and quality of life, as well as a higher diary dry rate (50.8% vs 36.0%, p = 0.002). Adverse effects were generally similar to those of younger populations including risk of urinary retention. Conclusions To our knowledge this is the first antimuscarinic study in a community based, significantly older, medically complex elderly population with urgency urinary incontinence. Flexible dose fesoterodine significantly improved urgency urinary incontinence episodes and other outcomes vs placebo, and was generally well tolerated.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 395-404 |
| Number of pages | 10 |
| Journal | Journal of Urology |
| Volume | 191 |
| Issue number | 2 |
| DOIs | |
| State | Published - Feb 2014 |
Bibliographical note
Funding Information:Joseph Catuogno, who was employed by Pfizer Inc when this study was conducted, contributed to study design, supervision and reporting. Robert D. Mayer, University of Rochester, Rochester, New York; Andrew R. McCullough, the Urological Institute of Northeastern New York, Albany, New York; Aubrey Morrison, Washington University School of Medicine, St. Louis, Missouri; and James Rochon, Rho, Durham, North Carolina, served on the independent data monitoring committee. Independent statistical analysis was provided by Christopher Wiesen, University of North Carolina, Chapel Hill, North Carolina, and was funded by Pfizer Inc. Medical writing support was provided by Diane DeHaven-Hudkins and Colin P. Mitchell from Complete Healthcare Communications, Inc., and was funded by Pfizer Inc.
Keywords
- fesoterodine
- muscarinic antagonists
- overactive
- urge
- urinary bladder
- urinary incontinence
- vulnerable populations