Voiding Efficiency, a Predictor of Clean Intermittent Catheterization (CIC)
Completed
- Conditions
- Urinary Bladder, Overactive
- Interventions
- Biological: onabotulinumtoxinA
- Registration Number
- NCT03043287
- Lead Sponsor
- Allergan
- Brief Summary
This study is a retrospective chart review of patients treated with onabotulinumtoxinA (BOTOX®) for idiopathic overactive bladder (OAB) and will determine voiding efficiency (VE) cutoff ratios that predict post-procedure urinary retention requiring catheterization.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 420
Inclusion Criteria
- Patient with documented idiopathic OAB diagnosis
- Patient was treated with 100-200U of BOTOX® for OAB
- Urodynamics assessment within prior to first BOTOX® injection.
Exclusion Criteria
- Patient had received botulinum toxin formulations other than BOTOX® in the bladder
- Patient had symptoms of OAB associated with a neurological condition (eg, spinal cord injury, multiple sclerosis, cerebrovascular accident, Alzheimer's disease, Parkinson's disease, etc).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description BOTOX® onabotulinumtoxinA Participants who received 100 to 200 units (U) onabotulinumtoxinA (BOTOX®) as treatment for OAB. No study drug is administered in this study.
- Primary Outcome Measures
Name Time Method Length of Time of CIC Use in Clinical Practice after Treatment with 100-200U BOTOX® 12 Weeks Pre-BOTOX® Injection VE Cutoff-Ratios that Predict the Risk of CIC following Treatment with 100-200U of BOTOX® Pre-BOTOX® Injection (Baseline) VE was calculated as the ratio of voided volume to the total bladder capacity.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Regional Urology
🇺🇸Shreveport, Louisiana, United States
Chesapeake Urology Associates, LLC
🇺🇸Baltimore, Maryland, United States
Virginia Urology
🇺🇸Richmond, Virginia, United States