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

NCT01945489 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 254

Last updated 2017-11-06

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

onabotulinumtoxinA

OnabotulinumtoxinA (BOTOX®) injected into the detrusor.

DRUG

Normal saline

Normal saline (placebo) injected into the detrusor.

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Tamer Aboushwareb · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-28
Primary Completion
2016-05-24
Completion
2017-01-05
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01945489 on ClinicalTrials.gov