Sustained improvement in patient-reported outcomes during long-term fesoterodine treatment for overactive bladder symptoms: Pooled analysis of two open-label extension studies - Abstract

St Thomas' Hospital, London, UK Department of Urology, Vanderbilt University Medical Center, Nashville, TN Pfizer Inc., New York, NY, USA.


Study Type - Outcomes (cohort) Level of Evidence 2b.

What's known on the subject? and What does the study add? Short-term (12-week) trials have demonstrated that subjects with OAB who receive treatment with fesoterodine 4- and 8-mg, either in fixed-dose or flexible-dose regimens, show significant improvements in measures of HRQL and other patient-reported outcomes. The results of this long-term, open-label study show that treatment with fesoterodine for up to 24 months resulted in sustained improvement in measures of HRQL and severity of bladder-related problems in subjects with OAB symptoms. Throughout the study, a high percentage of subjects reported satisfaction with fesoterodine treatment. The results were similar in men and women and across age groups (< 45 years; 45-64 years; 65-74; ≥75 years). Long term treatment with fesoterodine is beneficial to patients with overactive bladder.

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.

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.

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.

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.

Written by:
Kelleher CJ, Dmochowski RR, Berriman S, Kopp ZS, Carlsson M.   Are you the author?

Reference: BJU Int. 2011 Nov 30. Epub ahead of print.
doi: 10.1111/j.1464-410X.2011.10774.x

PubMed Abstract
PMID: 22129365 Overactive Bladder (OAB) Section