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NCT02557971 Clinical Trial

Urinary Retention Rates in Clinical Practice After Treatment With OnabotulinumtoxinA for Idiopathic Overactive Bladder

Urinary Bladder, Overactive Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02557971
Other study ID # GMA-US-OAB-0403
Secondary ID
Status Completed
Phase Phase 4
First received September 22, 2015
Last updated August 31, 2016
Start date August 2015
Est. completion date July 2016

Study information
Verified date August 2016
Source Allergan
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

This study is a retrospective chart review of patients treated with BOTOX® for idiopathic Overactive Bladder (OAB) as standard of care in clinical practice. The study will determine the rate of post procedural urinary retention requiring catheterization and identify factors that may predict urinary retention.

Recruitment information / eligibility
Status Completed
Enrollment 315
Est. completion date July 2016
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

-Patients treated with BOTOX® for Overactive Bladder.

Exclusion Criteria:

- Received botulinum toxin formulations other than BOTOX® in the bladder.

- Had symptoms of OAB associated with a neurological condition.

- Had a history of chronic urinary retention treated with Clean Intermittent Catheterization (CIC) or indwelling catheter.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Drug:
• onabotulinumtoxinA
OnabotulinumtoxinA (BOTOX®) as prescribed in clinical practice.

Locations
Country Name City State
United States The Charlotte-Mecklenburg Hospital Authority DBA Carolinas Healthcare System Charlotte North Carolina
United States MetroHealth Medical Center Cleveland Ohio
United States University of California, Davis Davis California
United States Alliance Urology Specialists, PA Greensboro North Carolina
United States Capital Region Urology Irvine California
United States Virginia Women's Center Inc. Richmond Virginia
United States Forsyth Memorial Hospital Inc. dba Novant Health Urology Partners Winston-Salem North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of Participants with Post-Procedure Urinary Retention requiring Catheterization 12 Weeks No
Primary Length of Time of Clean Intermittent Catheterization (CIC) Use 12 Weeks No
Secondary Percentage of Participants with Urinary Tract Infection (UTI) 12 Weeks No
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