Urinary Retention Rates in Clinical Practice After Treatment With OnabotulinumtoxinA for Idiopathic Overactive Bladder

NCT ID: NCT02557971

Last Updated: 2016-09-02

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

315 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-07-31

Brief Summary

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This study is a retrospective chart review of patients treated with BOTOX® for idiopathic Overactive Bladder (OAB) as standard of care in clinical practice. The study will determine the rate of post procedural urinary retention requiring catheterization and identify factors that may predict urinary retention.

Detailed Description

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Conditions

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Urinary Bladder, Overactive

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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BOTOX®

Patients with idiopathic overactive bladder (OAB) treated with onabotulinumtoxinA (BOTOX®) injections into the bladder as standard of care in clinical practice. No intervention was administered in this study.

onabotulinumtoxinA

Intervention Type DRUG

OnabotulinumtoxinA (BOTOX®) as prescribed in clinical practice.

Interventions

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onabotulinumtoxinA

OnabotulinumtoxinA (BOTOX®) as prescribed in clinical practice.

Intervention Type DRUG

Other Intervention Names

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BOTOX® botulinum toxin Type A

Eligibility Criteria

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Inclusion Criteria

-Patients treated with BOTOX® for Overactive Bladder.

Exclusion Criteria

* Received botulinum toxin formulations other than BOTOX® in the bladder.
* Had symptoms of OAB associated with a neurological condition.
* Had a history of chronic urinary retention treated with Clean Intermittent Catheterization (CIC) or indwelling catheter.
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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Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

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University of California, Davis

Davis, California, United States

Site Status

Capital Region Urology

Irvine, California, United States

Site Status

The Charlotte-Mecklenburg Hospital Authority DBA Carolinas Healthcare System

Charlotte, North Carolina, United States

Site Status

Alliance Urology Specialists, PA

Greensboro, North Carolina, United States

Site Status

Forsyth Memorial Hospital Inc. dba Novant Health Urology Partners

Winston-Salem, North Carolina, United States

Site Status

MetroHealth Medical Center

Cleveland, Ohio, United States

Site Status

Virginia Women's Center Inc.

Richmond, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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GMA-US-OAB-0403

Identifier Type: -

Identifier Source: org_study_id

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