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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02557971
Recruitment Status : Completed
First Posted : September 23, 2015
Last Update Posted : September 2, 2016
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
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.

Condition or disease Intervention/treatment
Urinary Bladder, Overactive Drug: onabotulinumtoxinA

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Study Type : Observational
Actual Enrollment : 315 participants
Observational Model: Cohort
Time Perspective: Retrospective
Study Start Date : August 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Percentage of Participants with Post-Procedure Urinary Retention requiring Catheterization [ Time Frame: 12 Weeks ]
  2. Length of Time of Clean Intermittent Catheterization (CIC) Use [ Time Frame: 12 Weeks ]

Secondary Outcome Measures :
  1. Percentage of Participants with Urinary Tract Infection (UTI) [ Time Frame: 12 Weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients prescribed BOTOX® for the treatment of idiopathic OAB in clinical practice.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02557971


Locations
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United States, California
University of California, Davis
Davis, California, United States, 95616
Capital Region Urology
Irvine, California, United States, 92612
United States, North Carolina
The Charlotte-Mecklenburg Hospital Authority DBA Carolinas Healthcare System
Charlotte, North Carolina, United States, 28203
Alliance Urology Specialists, PA
Greensboro, North Carolina, United States, 27403
Forsyth Memorial Hospital Inc. dba Novant Health Urology Partners
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
United States, Virginia
Virginia Women's Center Inc.
Richmond, Virginia, United States, 23233
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Medical Director Allergan
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02557971    
Other Study ID Numbers: GMA-US-OAB-0403
First Posted: September 23, 2015    Key Record Dates
Last Update Posted: September 2, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents