CompletedNot Applicable

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

United States420 participantsStarted 2017-05-12

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

What they're measuring

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

Timeframe: Pre-BOTOX® Injection (Baseline)

Length of Time of CIC Use in Clinical Practice after Treatment with 100-200U BOTOX®

Timeframe: 12 Weeks

Trial details

NCT IDNCT03043287

SponsorAllergan

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2019-09-09

View on ClinicalTrials.gov More Urinary Bladder, Overactive trials