TY - JOUR
T1 - Modifiers of Response to Treatment with Fesoterodine for Urgency-Predominant Urinary Incontinence in a Randomized Controlled Trial
AU - Winkelman, William D.
AU - Huang, Alison J.
AU - Schembri, Michael
AU - Rogers, Rebecca G.
AU - Richter, Holly
AU - Myers, Deborah L.
AU - Kraus, Stephen R.
AU - Johnson, Karen C.
AU - Hess, Rachel
AU - Gregory, Tomas
AU - Bradley, Catherine S.
AU - Arya, Lily
AU - Brown, Janette S.
AU - Subak, Leslee L.
N1 - Funding Information:
L.L.S., J.S.B., and A.J.H. have received a University of California San Francisco research grant from Pfizer, Inc, to conduct research related to urinary incontinence. Pfizer, Inc, provided funding for the study and the study medication but did not provide other input into the design of the study; collection, analysis, or interpretation of data; writing of the report; or the decision to submit the paper for publication. L.L.S. is additionally supported by NIDDK K24 DK080775. L.L.S. had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. No manuscript preparation assistance was provided by the study funders. L.L.S. and A.J.H. receive investigator-initiated trial funding from Astellas, Inc. A.J.H. was additionally supported by grants RR024130 and 1K23AG038335-01A1 and L.L.S. from 2K24DK080775-06 from the US National Institutes of Health; however, the views expressed in this article do not necessarily represent those of the National Institutes of Health. L.A. has received a research grant from Pfizer, Inc. H.R. has received a research grant and participated in a speaker's bureau for Pfizer, Inc; received a research grant and participated in an advisory board for Astellas; and served as a consultant for Uromedica and GlaxoSmithKline. S.R.K. has served as a consultant for Pfizer, Inc, and Allergan and has been a course director and teaching faculty member for Laborie. The other authors declare that they have nothing to disclose.
Publisher Copyright:
© 2016 Wolters Kluwer Health, Inc. All rights reserved.
PY - 2017/3/1
Y1 - 2017/3/1
N2 - Objective The aim of this study was to identify clinical and demographic characteristics that moderate response to treatment with fesoterodine among women with a diagnosis of urgency-predominant urinary incontinence. Methods A multicenter, double-blinded, 12-week randomized controlled trial of pharmacologic therapy for urgency-predominant urinary incontinence in community-dwelling women diagnosed by the 3-item Incontinence Questionnaire (3IQ) was previously performed. Participants (N = 645) were randomized to fesoterodine therapy (4-8 mg daily; n = 322) or placebo (n = 323). Urinary incontinence was assessed by 3-day voiding diaries. In this secondary analysis, a "responder" was defined as reduction of 50% or greater in overall incontinence episode frequency compared with baseline. Clinical and demographic characteristics that may moderate treatment response were assessed by testing for interaction between characteristics and intervention in logit models of responders, adjusting for clinical site. Results Participants' ages were a mean of 56 (SD, 14) years, 68% were white race, and they had a mean of 3.9 (SD, 3.0) urgency incontinence episodes per day. There were no baseline differences in demographic, clinical, or incontinence characteristics between treatment and placebo groups or between responders and nonresponders. There was an increase in the proportion of responders to fesoterodine with increasing age (P = 0.04) and parity (0.04) and among married women (P = 0.03), but no effect modification was observed by race/ethnicity, body mass index, education, employment status, or alcohol or tobacco use. Conclusions In ambulatory women with urgency-predominant urinary incontinence, older age, being married, and higher parity significantly moderated and potentiated the effects of pharmacologic therapy on incontinence frequency. This study identifies certain populations who may have increased responsiveness to treatment with antimuscarinic therapy and may be used to inform and guide future therapy.
AB - Objective The aim of this study was to identify clinical and demographic characteristics that moderate response to treatment with fesoterodine among women with a diagnosis of urgency-predominant urinary incontinence. Methods A multicenter, double-blinded, 12-week randomized controlled trial of pharmacologic therapy for urgency-predominant urinary incontinence in community-dwelling women diagnosed by the 3-item Incontinence Questionnaire (3IQ) was previously performed. Participants (N = 645) were randomized to fesoterodine therapy (4-8 mg daily; n = 322) or placebo (n = 323). Urinary incontinence was assessed by 3-day voiding diaries. In this secondary analysis, a "responder" was defined as reduction of 50% or greater in overall incontinence episode frequency compared with baseline. Clinical and demographic characteristics that may moderate treatment response were assessed by testing for interaction between characteristics and intervention in logit models of responders, adjusting for clinical site. Results Participants' ages were a mean of 56 (SD, 14) years, 68% were white race, and they had a mean of 3.9 (SD, 3.0) urgency incontinence episodes per day. There were no baseline differences in demographic, clinical, or incontinence characteristics between treatment and placebo groups or between responders and nonresponders. There was an increase in the proportion of responders to fesoterodine with increasing age (P = 0.04) and parity (0.04) and among married women (P = 0.03), but no effect modification was observed by race/ethnicity, body mass index, education, employment status, or alcohol or tobacco use. Conclusions In ambulatory women with urgency-predominant urinary incontinence, older age, being married, and higher parity significantly moderated and potentiated the effects of pharmacologic therapy on incontinence frequency. This study identifies certain populations who may have increased responsiveness to treatment with antimuscarinic therapy and may be used to inform and guide future therapy.
KW - fesoterodine
KW - predictors of treatment response
KW - urgency urinary incontinence
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U2 - 10.1097/SPV.0000000000000396
DO - 10.1097/SPV.0000000000000396
M3 - Article
C2 - 28118174
AN - SCOPUS:85014647849
SN - 2151-8378
VL - 23
SP - 151
EP - 156
JO - Female Pelvic Medicine and Reconstructive Surgery
JF - Female Pelvic Medicine and Reconstructive Surgery
IS - 2
ER -