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

Allergan

Status: Completed

Conditions: Urinary Bladder, Overactive

Treatments: Biological: onabotulinumtoxinA

Study type: Observational

Funder types: Industry

Identifiers

NCT03043287

CMO-US-URO-0506

Details and patient eligibility

About

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.

Enrollment: 420 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

420 participants in 1 patient group

BOTOX®

Description:

Participants who received 100 to 200 units (U) onabotulinumtoxinA (BOTOX®) as treatment for OAB. No study drug is administered in this study.

Treatment:

Biological: onabotulinumtoxinA