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Flexible-dose fesoterodine in elderly adults with overactive bladder: results of the randomized, double-blind, placebo-controlled study of fesoterodine in an aging population trial.
J Am Geriatr Soc. 2013 Feb; 61(2):185-93.JA

Abstract

OBJECTIVES

To assess the efficacy and safety of flexible-dose fesoterodine in elderly adults with overactive bladder (OAB).

DESIGN

Twelve-week, randomized, double-blind, placebo-controlled trial.

SETTING

Sixty-one outpatient clinics in Europe, Israel, and Turkey.

PARTICIPANTS

Seven hundred ninety-four individuals aged 65 and older (47% male) with OAB symptoms for 3 months or longer, mean of eight or more micturitions and three or more urgency episodes per 24 hours, at least some moderate problems on Patient Perception of Bladder Condition (PPBC), and Mini-Mental State Examination (MMSE) score of 20 or greater.

INTERVENTIONS

Participants were randomized to fesoterodine or placebo for 12 weeks, with stratification according to age (>75 vs ≤ 75) and dosing time (morning vs evening). Participants receiving fesoterodine started on 4 mg and could increase to 8 mg at week 4 or 8 and de-escalate to 4 mg at week 8 (sham escalation for placebo).

MEASUREMENTS

Changes from baseline in bladder-diary variables (primary endpoint, urgency episodes) and patient-reported outcomes including OAB Questionnaire, Treatment Benefit Scale (TBS), PPBC, Urgency Perception Scale (UPS), and OAB Satisfaction Questionnaire (OAB-S); all observed or reported adverse events.

RESULTS

By week 8, 64% of fesoterodine-treated and 71% of placebo-treated participants opted for dose escalation. At week 12, the fesoterodine group had statistically significantly greater improvement than the placebo group in urgency episodes, micturitions, nocturnal micturitions, incontinence pad use, and OAB Questionnaire scores but not urgency urinary incontinence episodes. Responder rates on TBS, PPBC, UPS, and OAB-S were statistically significantly higher with fesoterodine. Improvements in most diary variables and participant-reported outcomes were greater with fesoterodine than placebo in participants in both age groups and when administered in the morning and evening. Rates of dry mouth and constipation were 34% and 9% with fesoterodine and 5% and 3% with placebo, respectively. Rates of adverse events and discontinuations were generally similar in participants in both age groups. There was no change in MMSE score.

CONCLUSION

Fesoterodine was associated with significantly greater improvements in most diary variables and participant-reported outcomes than placebo and was generally well tolerated in older people.

Authors+Show Affiliations

Division of Geriatric Medicine, University of Alberta, Edmonton, Alberta, Canada. adrian.wagg@ualberta.caNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23350833

Citation

Wagg, Adrian, et al. "Flexible-dose Fesoterodine in Elderly Adults With Overactive Bladder: Results of the Randomized, Double-blind, Placebo-controlled Study of Fesoterodine in an Aging Population Trial." Journal of the American Geriatrics Society, vol. 61, no. 2, 2013, pp. 185-93.
Wagg A, Khullar V, Marschall-Kehrel D, et al. Flexible-dose fesoterodine in elderly adults with overactive bladder: results of the randomized, double-blind, placebo-controlled study of fesoterodine in an aging population trial. J Am Geriatr Soc. 2013;61(2):185-93.
Wagg, A., Khullar, V., Marschall-Kehrel, D., Michel, M. C., Oelke, M., Darekar, A., Bitoun, C. E., Weinstein, D., & Osterloh, I. (2013). Flexible-dose fesoterodine in elderly adults with overactive bladder: results of the randomized, double-blind, placebo-controlled study of fesoterodine in an aging population trial. Journal of the American Geriatrics Society, 61(2), 185-93. https://doi.org/10.1111/jgs.12088
Wagg A, et al. Flexible-dose Fesoterodine in Elderly Adults With Overactive Bladder: Results of the Randomized, Double-blind, Placebo-controlled Study of Fesoterodine in an Aging Population Trial. J Am Geriatr Soc. 2013;61(2):185-93. PubMed PMID: 23350833.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Flexible-dose fesoterodine in elderly adults with overactive bladder: results of the randomized, double-blind, placebo-controlled study of fesoterodine in an aging population trial. AU - Wagg,Adrian, AU - Khullar,Vik, AU - Marschall-Kehrel,Daniela, AU - Michel,Martin C, AU - Oelke,Matthias, AU - Darekar,Amanda, AU - Bitoun,Caty E, AU - Weinstein,David, AU - Osterloh,Ian, Y1 - 2013/01/25/ PY - 2013/1/29/entrez PY - 2013/1/29/pubmed PY - 2013/4/10/medline SP - 185 EP - 93 JF - Journal of the American Geriatrics Society JO - J Am Geriatr Soc VL - 61 IS - 2 N2 - OBJECTIVES: To assess the efficacy and safety of flexible-dose fesoterodine in elderly adults with overactive bladder (OAB). DESIGN: Twelve-week, randomized, double-blind, placebo-controlled trial. SETTING: Sixty-one outpatient clinics in Europe, Israel, and Turkey. PARTICIPANTS: Seven hundred ninety-four individuals aged 65 and older (47% male) with OAB symptoms for 3 months or longer, mean of eight or more micturitions and three or more urgency episodes per 24 hours, at least some moderate problems on Patient Perception of Bladder Condition (PPBC), and Mini-Mental State Examination (MMSE) score of 20 or greater. INTERVENTIONS: Participants were randomized to fesoterodine or placebo for 12 weeks, with stratification according to age (>75 vs ≤ 75) and dosing time (morning vs evening). Participants receiving fesoterodine started on 4 mg and could increase to 8 mg at week 4 or 8 and de-escalate to 4 mg at week 8 (sham escalation for placebo). MEASUREMENTS: Changes from baseline in bladder-diary variables (primary endpoint, urgency episodes) and patient-reported outcomes including OAB Questionnaire, Treatment Benefit Scale (TBS), PPBC, Urgency Perception Scale (UPS), and OAB Satisfaction Questionnaire (OAB-S); all observed or reported adverse events. RESULTS: By week 8, 64% of fesoterodine-treated and 71% of placebo-treated participants opted for dose escalation. At week 12, the fesoterodine group had statistically significantly greater improvement than the placebo group in urgency episodes, micturitions, nocturnal micturitions, incontinence pad use, and OAB Questionnaire scores but not urgency urinary incontinence episodes. Responder rates on TBS, PPBC, UPS, and OAB-S were statistically significantly higher with fesoterodine. Improvements in most diary variables and participant-reported outcomes were greater with fesoterodine than placebo in participants in both age groups and when administered in the morning and evening. Rates of dry mouth and constipation were 34% and 9% with fesoterodine and 5% and 3% with placebo, respectively. Rates of adverse events and discontinuations were generally similar in participants in both age groups. There was no change in MMSE score. CONCLUSION: Fesoterodine was associated with significantly greater improvements in most diary variables and participant-reported outcomes than placebo and was generally well tolerated in older people. SN - 1532-5415 UR - https://www.unboundmedicine.com/medline/citation/23350833/Flexible_dose_fesoterodine_in_elderly_adults_with_overactive_bladder:_results_of_the_randomized_double_blind_placebo_controlled_study_of_fesoterodine_in_an_aging_population_trial_ L2 - https://doi.org/10.1111/jgs.12088 DB - PRIME DP - Unbound Medicine ER -