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Early and Consistent Improvements in Urinary Symptoms and Quality of Life With OnabotulinumtoxinA in Patients With Overactive Bladder and Urinary Incontinence: Results From a Randomized, Placebo-controlled, Phase IV Clinical Trial.

Authors :
McCammon K
Gousse A
Kohan A
Glazier D
Gruenenfelder J
Bai Z
Patel A
Hale D
Source :
Female pelvic medicine & reconstructive surgery [Female Pelvic Med Reconstr Surg] 2021 Jul 01; Vol. 27 (7), pp. 450-456.
Publication Year :
2021

Abstract

Objectives: This randomized, multicenter, placebo-controlled, phase IV study assessed the efficacy and tolerability of onabotulinumtoxinA in patients with overactive bladder.<br />Methods: Patients were randomized 1:1 to onabotulinumtoxinA 100 U or placebo. Assessments over 12 weeks included: change from baseline in urinary incontinence (UI) episodes/day; proportions of patients who achieved 100% and 50% or greater reductions in UI episodes/day; proportion of patients using no incontinence pads in the previous 24 hours; and changes from baseline in micturition frequency, nocturia, urgency UI, Incontinence-Quality of Life, King's Health Questionnaire, International Consultation on Incontinence Questionnaire-UI Short Form scores and time to request retreatment.<br />Results: Significant reductions in UI episodes/day were seen with onabotulinumtoxinA versus placebo within week 1 posttreatment (-2.9 vs -2.0, P = 0.005) through week 12 (coprimary endpoint: -3.5 vs -1.6, P < 0.001). Significantly more onabotulinumtoxinA-treated patients achieved 100% (coprimary endpoint) and 50% or greater reductions in UI episodes/day. Decreases in other urinary symptoms were also seen within 1 week with onabotulinumtoxinA that continued through at least week 12. More onabotulinumtoxinA-treated versus placebo-treated patients required no incontinence pads at weeks 1 to 12, and greater improvements in quality of life measurements were seen. Time to request retreatment was significantly longer with onabotulinumtoxinA versus placebo (30.0 weeks vs 13.1 weeks; P < 0.001). No unexpected safety signals were observed. Urinary tract infection was the most commonly observed adverse event.<br />Conclusions: Urinary symptom and quality of life improvements were observed with onabotulinumtoxinA within 1 week of treatment and were sustained for at least 12 weeks.<br />Competing Interests: Conflicts of Interest and Source of Funding: This study and its analysis were sponsored by Allergan plc, Dublin, Ireland. Medical writing and editorial assistance was provided by Jennifer L. Giel, PhD, CMPP, and Karen Pemberton, PhD, CMPP, on behalf of Evidence Scientific Solutions, Inc., Philadelphia, PA, and was funded by Allergan plc, Dublin, Ireland.<br /> (Copyright © 2020 The Author(s). Published by Wolters Kluwer Health, Inc.)

Details

Language :
English
ISSN :
2154-4212
Volume :
27
Issue :
7
Database :
MEDLINE
Journal :
Female pelvic medicine & reconstructive surgery
Publication Type :
Academic Journal
Accession number :
32665528
Full Text :
https://doi.org/10.1097/SPV.0000000000000914