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

Voiding Efficiency, a Predictor of CIC

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03043287
Enrollment
420
Registered
2017-02-06
Start date
2017-05-12
Completion date
2019-09-30
Last updated
2020-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Bladder, Overactive

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.

Interventions

BIOLOGICALonabotulinumtoxinA

onabotulinumtoxinA (BOTOX®)100 to 200 U

Sponsors

Allergan
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
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.
Length of Time of CIC Use in Clinical Practice after Treatment with 100-200U BOTOX®12 Weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026