Effect of fesoterodine 4  mg on bladder diary and patient-reported outcomes during the first week of treatment in subjects with overactive bladder.

AbstractObjective:To assess the onset of efficacy of fesoterodine 4  mg versus placebo in subjects with overactive bladder (OAB) symptomsResearch design and methods:Subjects who reported OAB symptoms for ≥3 months and recorded ≥8 micturitions and ≥1 urgency urinary incontinence (UUI) episode per 24...

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Publicado en:Current Medical Research & Opinion Vol. 27; no. 5; pp. 1059 - 1066
Autores principales: Jacques Corcos, Javier C. Angulo, Alan D. Garely, Martin Carlsson, Jason Gong, Zhonghong Guan
Formato: research randomized controlled trial Journal Article
Publicado: Taylor & Francis Ltd May2011
Acceso en línea:Ver este registro en EBSCOhost
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        atl: Effect of fesoterodine 4  mg on bladder diary and patient-reported outcomes during the first week of treatment in subjects with overactive bladder.
      aug:
        au:
          Jacques Corcos
          Javier C. Angulo
          Alan D. Garely
          Martin Carlsson
          Jason Gong
          Zhonghong Guan
      sug:
        subj:
          Benzhydryl Compounds Administration and Dosage
          Overactive Bladder Drug Therapy
          Overactive Bladder Physiopathology
          Bladder Physiopathology
          Multicenter Studies
          Randomized Controlled Trials
          Random Assignment
          Scales
          Questionnaires
          Adult
          Aged
          Aged, 80 and Over
          Benzhydryl Compounds Adverse Effects
          Double-Blind Studies
          Female
          Human
          Male
          Middle Age
          Time Factors
          Adult: 19-44 years
          Aged: 65+ years
          Aged, 80 & over
          Middle Aged: 45-64 years
          Female
          Male
      ab: AbstractObjective:To assess the onset of efficacy of fesoterodine 4  mg versus placebo in subjects with overactive bladder (OAB) symptomsResearch design and methods:Subjects who reported OAB symptoms for ≥3 months and recorded ≥8 micturitions and ≥1 urgency urinary incontinence (UUI) episode per 24 hours in 3-day baseline diaries were randomized to fesoterodine 4  mg, tolterodine extended release (ER) 4  mg, or placebo. This is an analysis of first week data from a 12-week, double-blind trial.ClinicalTrials.gov unique ID: NCT00444925Main outcome measures:Baseline to week 1 changes in 3-day bladder diary variables, Patient Perception of Bladder Condition (PPBC), and Urgency Perception Scale (UPS) scores reported by subjects receiving fesoterodine 4  mg or placebo.Results:By week 1, fesoterodine 4  mg (n  =  679) was associated with significantly greater improvements compared with placebo (n  =  334) in micturitions, urgency, severe urgency and UUI episodes, frequency-urgency sum, and MVV per 24 hours and 3-day diary-dry rate (all p  <  0.05), but not nocturnal micturitions per 24 hours (p  =  0.273). These differences were significant as early as day 5 of treatment (i.e., day 1 of the 3-day diary) for all diary endpoints except nocturnal micturitions and MVV. Changes in PPBC scores were significantly more favorable with fesoterodine 4  mg versus placebo (p  =  0.0143); changes in UPS scores were not significantly different (p  =  0.077).Conclusion:The results provide evidence that patients receiving fesoterodine 4  mg for their OAB symptoms may expect to experience a response as early as 1 week after initiating treatment. One limitation is that, although 65% of subjects had received treatment with antimuscarinics before the study, whether subjects were dissatisfied with previous treatment and reasons for dissatisfaction were not collected. This might affect the magnitude of outcome improvements. Also, it is not known whether the UPS is sensitive enough to detect treatment differences as early as week 1.
      pubtype: Academic Journal
      doctype:
        research
        randomized controlled trial
        Journal Article
      ougenre: Article
    language: English
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