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

NCT03052764 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2019-12-24

Study results available
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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

Interventions

BIOLOGICAL

onabotulinumtoxinA

OnabotulinumtoxinA (BOTOX®) injection into the bladder.

DRUG

Placebo (saline)

Placebo (saline) injection into the bladder.

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Dana Fetterolf · Allergan

  • Amin Boroujerdi · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-12
Primary Completion
2018-12-10
Completion
2018-12-10

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 NCT03052764 on ClinicalTrials.gov