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

Completed

• Conditions: Urinary Bladder, Overactive
• Interventions: Drug: onabotulinumtoxinA

• Registration Number: NCT02557971
• Lead Sponsor: Allergan

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-09-22
• Study First Submitted QC: 2015-09-22
• Study First Posted: 2015-09-23
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-31
• Last Update Posted: 2016-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 315

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BOTOX®	onabotulinumtoxinA	Patients with idiopathic overactive bladder (OAB) treated with onabotulinumtoxinA (BOTOX®) injections into the bladder as standard of care in clinical practice. No intervention was administered in this study.

Primary Outcome Measures

Name	Time	Method
Length of Time of Clean Intermittent Catheterization (CIC) Use	12 Weeks
Percentage of Participants with Post-Procedure Urinary Retention requiring Catheterization	12 Weeks

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants with Urinary Tract Infection (UTI)	12 Weeks

Trial Locations

Locations (7)

The Charlotte-Mecklenburg Hospital Authority DBA Carolinas Healthcare System; 🇺🇸 Charlotte, North Carolina, United States

University of California, Davis; 🇺🇸 Davis, California, United States

Capital Region Urology; 🇺🇸 Irvine, California, United States

Alliance Urology Specialists, PA; 🇺🇸 Greensboro, North Carolina, United States

Virginia Women's Center Inc.; 🇺🇸 Richmond, Virginia, United States

Forsyth Memorial Hospital Inc. dba Novant Health Urology Partners; 🇺🇸 Winston-Salem, North Carolina, United States

MetroHealth Medical Center; 🇺🇸 Cleveland, Ohio, United States