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    Effect of fesoterodine in vulnerable elderly subjects with urgency incontinence: a double-blind, placebo controlled trial

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    Authors
    DuBeau, Catherine E.
    Kraus, Stephen R.
    Griebling, Tomas L.
    Newman, Diane K.
    Wyman, Jean F.
    Johnson, Theodore M. 2nd
    Ouslander, Joseph G.
    Sun, Franklin
    Gong, Jason
    Bavendam, Tamara
    UMass Chan Affiliations
    Department of Medicine, Division of Geriatric Medicine
    Document Type
    Journal Article
    Publication Date
    2014-02-01
    Keywords
    Aged
    Aged, 80 and over
    Benzhydryl Compounds
    Dose-Response Relationship, Drug
    Double-Blind Method
    Female
    Humans
    Male
    Muscarinic Antagonists
    Urinary Incontinence, Urge
    Urological Agents
    Vulnerable Populations
    Female Urogenital Diseases and Pregnancy Complications
    Geriatrics
    Male Urogenital Diseases
    Urology
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    http://dx.doi.org/10.1016/j.juro.2013.08.027
    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. Published by Elsevier Inc. All rights reserved.
    Source
    J Urol. 2014 Feb;191(2):395-404. doi: 10.1016/j.juro.2013.08.027. Epub 2013 Aug 21. Link to article on publisher's site
    DOI
    10.1016/j.juro.2013.08.027
    Permanent Link to this Item
    http://hdl.handle.net/20.500.14038/30250
    PubMed ID
    23973522
    Related Resources
    Link to Article in PubMed
    ae974a485f413a2113503eed53cd6c53
    10.1016/j.juro.2013.08.027
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