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

NCT03320850 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 383

Last updated 2021-08-13

Study results available
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Summary

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

Conditions

Interventions

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

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Till Geib · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-04
Primary Completion
2020-07-21
Completion
2020-07-21
FDA Drug
Yes

Countries

  • United States
  • Canada

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 NCT03320850 on ClinicalTrials.gov