David R Staskin1, Alexis E Te. 1. Female Urology and Voiding Dysfunction, Weill Medical College of Cornell University, New York, NY 10021. USA. das2021@med.cornell.edu
Abstract
OBJECTIVE: To evaluate urinary symptom relief in women with mixed urinary incontinence (MUI) treated for up to 52 weeks with solifenacin succinate for overactive bladder (OAB), as MUI is a complex and distressing condition reported by about a third of incontinent women, and with confirmed efficacy in OAB-related urge incontinence, anticholinergic agents are a reasonable therapeutic option for such women. PATIENTS AND METHODS: Patients with OAB (mean of > or = 8 voids/24 h, plus > or = 1 incontinence episode or > or = 1 urgency episode/24 h) were pooled from four studies. A subgroup of 1041 patients reporting MUI at baseline were evaluated over 12 weeks in a double-blind, placebo-controlled study, and up to a further 40 weeks in 433 in an open-label solifenacin treatment (5 mg and 10 mg). Voiding frequency, episodes of incontinence and urgency, and volume voided per void, were collected from voiding diaries completed during the 3 days before each study visit. RESULTS: Patients with a history of MUI treated with solifenacin for up to 12 weeks had statistically significant reductions in voiding frequency and episodes of incontinence and urgency vs placebo. In all, 43% and 49% (at 5 mg and 10 mg, respectively) of patients with a history of MUI regained continence after 12 weeks, vs 33% with placebo. Among patients in the open-label study with mixed symptoms, 52% reported regaining continence, and 34% reported resolution of symptomatic urgency based on diary reporting at study end. Sustained improvements in quality of life and high satisfaction ratings accompanied symptom improvements. CONCLUSIONS: Significant reductions in OAB-related frequency, incontinence and urgency were reported after 12 weeks of solifenacin treatment in patients with a history of MUI. Symptom improvement in this subgroup was maintained during long-term treatment. These findings support the therapeutic potential of solifenacin for treating symptoms of MUI and the need to re-evaluate classically defined MUI.
RCT Entities:
OBJECTIVE: To evaluate urinary symptom relief in women with mixed urinary incontinence (MUI) treated for up to 52 weeks with solifenacin succinate for overactive bladder (OAB), as MUI is a complex and distressing condition reported by about a third of incontinent women, and with confirmed efficacy in OAB-related urge incontinence, anticholinergic agents are a reasonable therapeutic option for such women. PATIENTS AND METHODS: Patients with OAB (mean of > or = 8 voids/24 h, plus > or = 1 incontinence episode or > or = 1 urgency episode/24 h) were pooled from four studies. A subgroup of 1041 patients reporting MUI at baseline were evaluated over 12 weeks in a double-blind, placebo-controlled study, and up to a further 40 weeks in 433 in an open-label solifenacin treatment (5 mg and 10 mg). Voiding frequency, episodes of incontinence and urgency, and volume voided per void, were collected from voiding diaries completed during the 3 days before each study visit. RESULTS:Patients with a history of MUI treated with solifenacin for up to 12 weeks had statistically significant reductions in voiding frequency and episodes of incontinence and urgency vs placebo. In all, 43% and 49% (at 5 mg and 10 mg, respectively) of patients with a history of MUI regained continence after 12 weeks, vs 33% with placebo. Among patients in the open-label study with mixed symptoms, 52% reported regaining continence, and 34% reported resolution of symptomatic urgency based on diary reporting at study end. Sustained improvements in quality of life and high satisfaction ratings accompanied symptom improvements. CONCLUSIONS: Significant reductions in OAB-related frequency, incontinence and urgency were reported after 12 weeks of solifenacin treatment in patients with a history of MUI. Symptom improvement in this subgroup was maintained during long-term treatment. These findings support the therapeutic potential of solifenacin for treating symptoms of MUI and the need to re-evaluate classically defined MUI.
Authors: Rob Riemsma; Suzanne Hagen; Ruth Kirschner-Hermanns; Christine Norton; Helle Wijk; Karl-Erik Andersson; Christopher Chapple; Julian Spinks; Adrian Wagg; Edward Hutt; Kate Misso; Sohan Deshpande; Jos Kleijnen; Ian Milsom Journal: BMC Med Date: 2017-03-24 Impact factor: 8.775