NCT03052764

Evaluation of an Alternative Injection Paradigm for OnabotulinumtoxinA (BOTOX®) in the Treatment of Overactive Bladder in Patients With Urinary Incontinence

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate an Alternative Injection Paradigm for OnabotulinumtoxinA (BOTOX®) in the Treatment of Overactive Bladder in Patients With Urinary Incontinence (LO-BOT)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy and safety of onabotulinumtoxinA 100 U (BOTOX®), compared to placebo, when injected into the bladder using an alternative injection paradigm in reducing the number of daily urinary incontinence episodes in patients with overactive bladder (OAB) and urinary incontinence whose symptoms have not been adequately managed with an anticholinergic.

Conditions

• Urinary Bladder, Overactive
• Urinary Incontinence

Interventions

Type	Name	Description
BIOLOGICAL	onabotulinumtoxinA	OnabotulinumtoxinA (BOTOX®) injection into the bladder.
DRUG	Placebo (saline)	Placebo (saline) injection into the bladder.

Timeline

• Start date: 2016-12-12
• Primary completion: 2018-12-10
• Completion: 2018-12-10
• First posted: 2017-02-14
• Last updated: 2019-12-24
• Results posted: 2019-12-24

Locations

31 sites across 1 country: United States