Premium
Impact of fesoterodine on quality of life: pooled data from two randomized trials
Author(s) -
Kelleher Con J.,
Tubaro Andrea,
Wang Joseph T.,
Kopp Zoe
Publication year - 2008
Publication title -
bju international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.773
H-Index - 148
eISSN - 1464-410X
pISSN - 1464-4096
DOI - 10.1111/j.1464-410x.2008.07710.x
Subject(s) - tolterodine , medicine , placebo , overactive bladder , urinary incontinence , quality of life (healthcare) , urology , randomized controlled trial , nursing , alternative medicine , pathology
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.