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

NCT02557971 | Completed

• 1 other identifier: GMA-US-OAB-0403
• Study Type: observational
• Target: 315
• Locations: 1 country
• Sites: 7

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.

Conditions

Urinary Bladder, Overactive

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants with Post-Procedure Urinary Retention requiring Catheterization

  12 Weeks

• Length of Time of Clean Intermittent Catheterization (CIC) Use

  12 Weeks

Secondary Outcomes (1)

• Percentage of Participants with Urinary Tract Infection (UTI)

  12 Weeks

Study Arms (1)

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

Interventions

onabotulinumtoxinA DRUG

OnabotulinumtoxinA (BOTOX®) as prescribed in clinical practice.

Also known as: BOTOX®, botulinum toxin Type A

BOTOX®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Patients treated with BOTOX® for Overactive Bladder.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Allergan: lead

Study Sites (7)

University of California, Davis

Davis, California, 95616, United States

Location

Capital Region Urology

Irvine, California, 92612, United States

Location

The Charlotte-Mecklenburg Hospital Authority DBA Carolinas Healthcare System

Charlotte, North Carolina, 28203, United States

Location

Alliance Urology Specialists, PA

Greensboro, North Carolina, 27403, United States

Location

Forsyth Memorial Hospital Inc. dba Novant Health Urology Partners

Winston-Salem, North Carolina, 27103, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Virginia Women's Center Inc.

Richmond, Virginia, 23233, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2015
• First Posted: September 23, 2015
• Study Start: August 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: September 2, 2016

Record last verified: 2016-08

Locations

US (7)