Abstract | OBJECTIVES: • To evaluate the effects of long-term fesoterodine treatment on health-related quality of life (HRQL) and treatment satisfaction in subjects with overactive bladder (OAB) symptoms. • To determine the impact of gender and age on these effects. PATIENTS AND METHODS: • This is a post hoc analysis of data pooled from identically designed open-label extensions of two randomized, double-blind, 12-week fesoterodine studies. • Initial treatment was once-daily fesoterodine 8 mg; subjects had the opportunity to receive open-label fesoterodine for ≥24 months. • After 1 month, subjects could elect dose reduction to 4 mg and subsequent re-escalation to 8 mg; dose reduction and re-escalation were each allowed once annually. • Changes in scores on the King's Health Questionnaire (KHQ), International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) and a Likert scale evaluating severity of bladder-related problems were assessed at open-label baseline and months 12 and 24; treatment satisfaction was assessed at open-label baseline and at months 4, 12 and 24. RESULTS: • A total of 864 enrolled subjects were included (men, n= 182; women, n= 682; aged <45 years, n= 134; 45-64 years, n= 432; 65-74 years, n= 204; ≥75 years, n= 94); most subjects (77%) who continued treatment maintained the 8-mg dose. • Among subjects in the overall population, there were significant improvements in all KHQ domains, ICIQ-SF scores, and bladder-related problems at open-label baseline vs double-blind baseline (P < 0.05); additional significant improvements were observed at months 12 and 24 vs open-label baseline in all outcomes (P < 0.05) except for the KHQ General Health Perception domain. • When data were stratified by gender or age, significant improvements at open-label baseline vs double-blind baseline were further significantly enhanced or sustained at months 12 and 24 for most KHQ domains, and for ICIQ-SF scores and bladder-related problems for all groups. Women had significantly greater improvements than men in the KHQ Emotion (P= 0.0173) and Severity/Coping (P= 0.0112) domains and ICIQ-SF scores (P= 0.0276) during open-label treatment. Subjects aged <45 years had significantly greater improvement in the Personal Relationships domain compared with those aged 45-64 years (P= 0.0357) and in the Sleep/Energy domain compared with all other groups (all P < 0.02). • Treatment satisfaction was high (≥92%) throughout open-label treatment regardless of gender or age. CONCLUSIONS: • Long-term fesoterodine treatment was associated with sustained improvement in measures of health-related quality of life and bladder-related problems and with high treatment satisfaction in subjects with overactive bladder symptoms. • Effects of gender and age were minimal.
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Authors | Con J Kelleher, Roger R Dmochowski, Sandra Berriman, Zoe S Kopp, Martin Carlsson |
Journal | BJU international
(BJU Int)
Vol. 110
Issue 3
Pg. 392-400
(Aug 2012)
ISSN: 1464-410X [Electronic] England |
PMID | 22129365
(Publication Type: Journal Article, Meta-Analysis, Research Support, Non-U.S. Gov't)
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Copyright | © 2011 THE AUTHORS. BJU INTERNATIONAL © 2011 BJU INTERNATIONAL. |
Chemical References |
- Benzhydryl Compounds
- Muscarinic Antagonists
- fesoterodine
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Topics |
- Aged
- Benzhydryl Compounds
(therapeutic use)
- Double-Blind Method
- Female
- Humans
- Male
- Middle Aged
- Muscarinic Antagonists
(therapeutic use)
- Patient Satisfaction
- Quality of Life
- Randomized Controlled Trials as Topic
- Surveys and Questionnaires
- Treatment Outcome
- Urinary Bladder, Overactive
(drug therapy)
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