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NCT03043287 Clinical Trial

Voiding Efficiency, a Predictor of Clean Intermittent Catheterization (CIC)

Urinary Bladder, Overactive Clinical Trial

Official title:
Voiding Efficiency, a Predictor of CIC

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03043287
Other study ID # CMO-US-URO-0506
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 12, 2017
Est. completion date September 30, 2019

Study information
Verified date February 2020
Source Allergan
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 420
Est. completion date September 30, 2019
Est. primary completion date September 9, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Biological:
• onabotulinumtoxinA
onabotulinumtoxinA (BOTOX®)100 to 200 U

Locations
Country Name City State
United States Chesapeake Urology Associates, LLC Baltimore Maryland
United States Virginia Urology Richmond Virginia
United States Regional Urology Shreveport Louisiana

Sponsors (1)
Lead Sponsor Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pre-BOTOX® Injection VE Cutoff-Ratios that Predict the Risk of CIC following Treatment with 100-200U of BOTOX® VE was calculated as the ratio of voided volume to the total bladder capacity. Pre-BOTOX® Injection (Baseline)
Primary Length of Time of CIC Use in Clinical Practice after Treatment with 100-200U BOTOX® 12 Weeks
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