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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Urinary Bladder, Overactive Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Regional Urology, Shreveport, Louisiana, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

onabotulinumtoxinA

Biological

onabotulinumtoxinA (BOTOX®)100 to 200 U

Other names: Botulinum Toxin Type A, BOTOX®

Primary outcomes

Pre-BOTOX® Injection VE Cutoff-Ratios that Predict the Risk of CIC following Treatment with 100-200U of BOTOX®

Time frame: Pre-BOTOX® Injection (Baseline)

VE was calculated as the ratio of voided volume to the total bladder capacity.
Length of Time of CIC Use in Clinical Practice after Treatment with 100-200U BOTOX®

Time frame: 12 Weeks

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Official study title

Voiding Efficiency, a Predictor of CIC

Important dates

Study start: 2017
Primary completion: 2019
Study completion: 2019
First posted: Feb 6, 2017
Registry last updated: Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed