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

August 31, 2016 updated by: Allergan
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

315

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Davis, California, United States, 95616
        • University of California, Davis
      • Irvine, California, United States, 92612
        • Capital Region Urology
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • The Charlotte-Mecklenburg Hospital Authority DBA Carolinas Healthcare System
      • Greensboro, North Carolina, United States, 27403
        • Alliance Urology Specialists, PA
      • Winston-Salem, North Carolina, United States, 27103
        • Forsyth Memorial Hospital Inc. dba Novant Health Urology Partners
    • Ohio
      • Cleveland, Ohio, United States, 44109
        • MetroHealth Medical Center
    • Virginia
      • Richmond, Virginia, United States, 23233
        • Virginia Women's Center Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients prescribed BOTOX® for the treatment of idiopathic OAB in clinical practice.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Drug: onabotulinumtoxinA
OnabotulinumtoxinA (BOTOX®) as prescribed in clinical practice.
Other Names:
  • BOTOX®
  • botulinum toxin Type A

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants with Post-Procedure Urinary Retention requiring Catheterization
Time Frame: 12 Weeks
12 Weeks
Length of Time of Clean Intermittent Catheterization (CIC) Use
Time Frame: 12 Weeks
12 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants with Urinary Tract Infection (UTI)
Time Frame: 12 Weeks
12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

September 22, 2015

First Submitted That Met QC Criteria

September 22, 2015

First Posted (Estimate)

September 23, 2015

Study Record Updates

Last Update Posted (Estimate)

September 2, 2016

Last Update Submitted That Met QC Criteria

August 31, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GMA-US-OAB-0403

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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