1352 FESOTERODINE IS EFFECTIVE AND WELL TOLERATED IN VULNERABLE ELDERLY SUBJECTS WITH URGENCY INCONTINENCE: A DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY

Abstract

You have accessJournal of UrologyUrodynamics/Incontinence/Female Urology: Incontinence - Evaluation & Therapy III1 Apr 20121352 FESOTERODINE IS EFFECTIVE AND WELL TOLERATED IN VULNERABLE ELDERLY SUBJECTS WITH URGENCY INCONTINENCE: A DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY Catherine DuBeau, Stephen R. Kraus, Tomas L. Griebling, Diane Newman, Jean Wyman, Joseph Ouslander, Franklin Sun, Joseph Catuogno, and Tamara Bavendam Catherine DuBeauCatherine DuBeau Worcester, MA More articles by this author , Stephen R. KrausStephen R. Kraus San Antonio, TX More articles by this author , Tomas L. GrieblingTomas L. Griebling Kansas City, KS More articles by this author , Diane NewmanDiane Newman Philadelphia, PA More articles by this author , Jean WymanJean Wyman Minneapolis, MN More articles by this author , Joseph OuslanderJoseph Ouslander Boca Raton, FL More articles by this author , Franklin SunFranklin Sun New York, NY More articles by this author , Joseph CatuognoJoseph Catuogno New York, NY More articles by this author , and Tamara BavendamTamara Bavendam New York, NY More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2012.02.1735AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Despite the high rate of overactive bladder (OAB) symptoms, including urgency urinary incontinence (UUI) in medically complex vulnerable elderly (VE), there are no data on the efficacy, safety and tolerability of antimuscarinics in this group. We therefore investigated the efficacy and safety of flexible-dose fesoterodine (FESO) vs placebo (PBO) in VE subjects with UUI. METHODS This was a 12-wk, randomized, double-blind, placebo-controlled, trial. Subjects were aged ≥65 y with a score ≥3 on the Vulnerable Elders Survey, a score ≥20 on the Mini Mental State Examination, and ≥2 but ≤15 UUI episodes and ≥ 8 micturitions per 24 h on 3-d baseline diaries. Subjects were randomized to flexible-dose FESO or PBO. Subjects receiving FESO started on 4 mg/d for 4 wk after which they could escalate to 8 mg based on a discussion with the investigator. Subjects receiving the 8-mg dose could de-escalate to 4 mg at any time during the remaining 8 wk (sham escalation and de-escalation for PBO). Primary endpoint was change from baseline to wk 12 in UUI episodes/24 h. Change from baseline to wk 12 in micturitions/24 h was also evaluated. Self-reported adverse events (AEs) were monitored. RESULTS 562 patients were randomized (281 per group); mean age was 75 y; 50.4% were aged ≥75 y. Mean reductions in UUI episodes and micturitions/24 h at wk 12 were significantly greater in the FESO group vs PBO (Figure). Dry mouth and constipation were the most common AEs (Table). Rates of discontinuation due to AEs were 5.0% (n=14) for PBO and 9.3% (n=26) for FESO. Serious AEs occurred in 6 (2.1%) subjects receiving PBO and 8 (2.8%) receiving FESO; none were considered treatment-related by the investigators. 9 subjects receiving FESO (3.2%) had urinary retention; 3 required catheterization. Table. Treatment-Emergent Adverse Events (All Causes; Incidence > 2% and Higher in the FESO Group) N (%) PBO n=281 FESO n=281 Subjects with AEs 120(42.7) 158(56.2) Discontinued due to AEs 14(5.0) 26(9.3) Dry mouth 17(6.0) 66(23.5) Constipation 12(4.3) 31(11.1) Urinary Retention⁎ 0 9(3.2) Diarrhea 7(2.5) 8(2.8) Fatigue 3(1.1) 8(2.8) Dyspepsia 1(0.7) 7(2.5) Headache 5(1.8) 7(2.5) Cough 2(0.7) 7(2.5) ⁎ 3 of the 9 subjects required catheterization. CONCLUSIONS This is the first antimuscarinic study in a medically complex VE OAB population with UUI. Subjects receiving flexible-dose FESO for 12 wk had significantly greater reduction in UUI episodes and micturitions vs the PBO group. FESO was overall well tolerated. © 2012 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 187Issue 4SApril 2012Page: e548-e549 Advertisement Copyright & Permissions© 2012 by American Urological Association Education and Research, Inc.MetricsAuthor Information Catherine DuBeau Worcester, MA More articles by this author Stephen R. Kraus San Antonio, TX More articles by this author Tomas L. Griebling Kansas City, KS More articles by this author Diane Newman Philadelphia, PA More articles by this author Jean Wyman Minneapolis, MN More articles by this author Joseph Ouslander Boca Raton, FL More articles by this author Franklin Sun New York, NY More articles by this author Joseph Catuogno New York, NY More articles by this author Tamara Bavendam New York, NY More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...