NCT03320850

BOTOX® Intravesical Instillation in Participants With Overactive Bladder and Urinary Incontinence

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Single-treatment, 2-stage, Dose-finding Study Evaluating the Efficacy and Safety of BOTOX® Intravesical Instillation in Participants With Overactive Bladder and Urinary Incontinence

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 383 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy and safety of BOTOX® intravesical instillation in participants with overactive bladder and urinary incontinence.

Conditions

• Urinary Incontinence
• Overactive Bladder With Urinary Incontinence

Interventions

Type	Name	Description
DRUG	OnabotulinumtoxinA and Hydrogel admixture	BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation
DRUG	Placebo and Hydrogel admixture	Placebo and Hydrogel admixture administered as a single intravesical instillation

Timeline

• Start date: 2017-10-04
• Primary completion: 2020-07-21
• Completion: 2020-07-21
• First posted: 2017-10-25
• Last updated: 2021-08-13
• Results posted: 2021-08-13

Locations

63 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study