OnabotulinumtoxinA (BOTOX®) Treatment for Urinary Incontinence in Patients With Overactive Bladder

NCT01945489 ↗

Phase 4 Completed 254 enrolled Allergan

RandomizedParallel-groupTriple-blindTreatment

Summary

This is a study to evaluate the efficacy and safety of onabotulinumtoxinA (BOTOX®) compared with placebo, in achieving a 100% reduction in urinary incontinence in patients with overactive bladder (OAB) not properly managed with an anticholinergic.

Timeline

Start: 2013-10-28
Primary completion: 2016-05-24
Completion: 2017-01-05

Outcome

Met primary endpoint

paper through week 12 (coprimary endpoint: -3.5 vs -1.6, P < 0.001). PMID 32665528 ↗

paper Significantly more onabotulinumtoxinA-treated patients achieved 100% (coprimary endpoint) and 50% or greater reductions in UI episodes/day. PMID 32665528 ↗

Publications

McCammon K, Gousse A, Kohan A, Glazier D, Gruenenfelder J, Bai Z, Patel A, Hale D. 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. Female Pelvic Med Reconstr Surg. 2021 Jul 1;27(7):450-456. doi: 10.1097/SPV.0000000000000914.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Botulinum toxin type A	Protein / enzyme biologic	100 iu	Other