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- Title
Impact of fesoterodine on quality of life: pooled data from two randomized trials.
- Authors
Kelleher, Con J.; Tubaro, Andrea; Wang, Joseph T.; Kopp, Zoe
- Abstract
OBJECTIVE To evaluate the effect of fesoterodine on health-related quality of life (HRQoL) in patients with overactive bladder (OAB) syndrome. PATIENTS AND METHODS Pooled data from two randomized placebo-controlled phase III studies were analysed. Eligible patients with frequency and urgency or urgency urinary incontinence were randomized to placebo or fesoterodine 4 or 8 mg for 12 weeks; one trial also included tolterodine extended release (tolterodine-ER) 4 mg. HRQoL was assessed using the King’s Health Questionnaire (KHQ), International Consultation on Incontinence Questionnaire–Short Form (ICIQ-SF), a six-point Likert scale measuring the severity of bladder-related problems, and treatment response. RESULTS By the end of treatment, all active-treatment groups had significantly improved HRQoL compared with those on placebo, as shown by an improvement in the KHQ and ICIQ-SF scores, treatment response rate, and a major improvement in self-reported bladder-related problems. The fesoterodine 8-mg group had statistically significant improvements over placebo in eight of nine KHQ domains. Fesoterodine 4 mg and tolterodine-ER produced statistically significant improvements in seven of nine KHQ domains. Fesoterodine 8 mg gave better results than 4 mg in two domains; Emotions and Symptom Severity ( P < 0.05). A major improvement (≥2 points) in bladder-related problems was reported by 33% of patients on fesoterodine 4 mg, 38% on fesoterodine 8 mg, and 34% on tolterodine-ER, vs 21% on placebo ( P < 0.001). CONCLUSIONS Fesoterodine significantly improved HRQoL in patients with OAB. Both fesoterodine 4 and 8 mg produced significant improvements on most KHQ domains, the ICIQ-SF, treatment response rate, and a Likert scale measuring bladder-related problems.
- Subjects
RANDOMIZED controlled trials; CLINICAL medicine research; CLINICAL pharmacology; PLACEBOS; URINARY organs; THERAPEUTICS; BEHAVIORAL medicine
- Publication
BJU International, 2008, Vol 102, Issue 1, p56
- ISSN
1464-4096
- Publication type
Article
- DOI
10.1111/j.1464-410X.2008.07710.x