title: Effect of fesoterodine in vulnerable elderly subjects with urgency incontinence: a double-blind, placebo controlled trial.
abstract: We evaluated the efficacy and safety of flexible dose fesoterodine in medically complex vulnerable elderly subjects with urgency urinary incontinence.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
authors: University of Massachusetts Medical School and UMass Memorial Medical Center, Worcester, Massachusetts. Electronic address: Catherine.DuBeau@umassmemorial.org.
authors: Catherine E
authors: CE
authors: Dubeau
authors: University of Texas Health Science Center at San Antonio, San Antonio, Texas.
authors: Stephen R
authors: SR
authors: Kraus
authors: University of Kansas, Kansas City, Kansas.
authors: Tomas L
authors: TL
authors: Griebling
authors: University of Pennsylvania, Philadelphia, Pennsylvania.
authors: Diane K
authors: DK
authors: Newman
authors: University of Minnesota, Minneapolis, Minnesota.
authors: Jean F
authors: JF
authors: Wyman
authors: Atlanta VA Medical Center and Emory University, Atlanta, Georgia.
authors: Theodore M
authors: TM
authors: Johnson
authors: Florida Atlantic University, Boca Raton, Florida.
authors: Joseph G
authors: JG
authors: Ouslander
authors: Pfizer Inc, New York, New York.
authors: Franklin
authors: F
authors: Sun
authors: Pfizer Inc, New York, New York.
authors: Jason
authors: J
authors: Gong
authors: Pfizer Inc, New York, New York.
authors: Tamara
authors: T
authors: Bavendam
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001559:Benzhydryl Compounds / Q000008:administration & dosage / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D018727:Muscarinic Antagonists / Q000008:administration & dosage / Q000627:therapeutic use*; D053202:Urinary Incontinence, Urge / Q000188:drug therapy*; D064804:Urological Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D035862:Vulnerable Populations
chemical_list: D001559:Benzhydryl Compounds; D018727:Muscarinic Antagonists; D064804:Urological Agents; C526675:fesoterodine
keywords: AEs; HRQL; OAB; PVR; UUI; VE; adverse events; fesoterodine; health related quality of life; muscarinic antagonists; overactive; overactive bladder; post-void residual urinary volume; urge; urgency urinary incontinence; urinary bladder; urinary incontinence; vulnerable elderly; vulnerable populations