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

NCT ID: NCT03043287

Last Updated: 2020-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

420 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-12

Study Completion Date

2019-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Urinary Bladder, Overactive

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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BOTOX®

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

onabotulinumtoxinA

Intervention Type BIOLOGICAL

onabotulinumtoxinA (BOTOX®)100 to 200 U

Interventions

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onabotulinumtoxinA

onabotulinumtoxinA (BOTOX®)100 to 200 U

Intervention Type BIOLOGICAL

Other Intervention Names

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Botulinum Toxin Type A BOTOX®

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dana Fetterolf

Role: STUDY_DIRECTOR

Allergan

Locations

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Regional Urology

Shreveport, Louisiana, United States

Site Status

Chesapeake Urology Associates, LLC

Baltimore, Maryland, United States

Site Status

Virginia Urology

Richmond, Virginia, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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CMO-US-URO-0506

Identifier Type: -

Identifier Source: org_study_id

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