Status:
COMPLETED
BOTOX® Intravesical Instillation in Participants With Overactive Bladder and Urinary Incontinence
Lead Sponsor:
Allergan
Conditions:
Urinary Incontinence
Overactive Bladder With Urinary Incontinence
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This study will evaluate the efficacy and safety of BOTOX® intravesical instillation in participants with overactive bladder and urinary incontinence.
Eligibility Criteria
Inclusion
- Symptoms of OAB (frequency/urgency) with urinary incontinence for at least 6 months
- Inadequate response or limiting side effects with pharmacotherapy for the treatment of OAB
Exclusion
- Overactive Bladder caused by neurological condition
- Patient has predominance of stress incontinence
- History or evidence of pelvic or urological abnormality
- Prior use of BOTOX for any urological condition
Key Trial Info
Start Date :
October 4 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 21 2020
Estimated Enrollment :
383 Patients enrolled
Trial Details
Trial ID
NCT03320850
Start Date
October 4 2017
End Date
July 21 2020
Last Update
August 13 2021
Active Locations (63)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
2
Coastal Clinical Research, Inc., an AMR company
Mobile, Alabama, United States, 36608
3
Urological Assoc. of South AZ
Tucson, Arizona, United States, 85715
4
Hope Clinical Research
Canoga Park, California, United States, 91303