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

NCT03043287 | Completed

• 1 other identifier: CMO-US-URO-0506
• Study Type: observational
• Target: 420
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Urinary Bladder, Overactive

Outcome Measures

Primary Outcomes (2)

• Pre-BOTOX® Injection VE Cutoff-Ratios that Predict the Risk of CIC following Treatment with 100-200U of BOTOX®

  VE was calculated as the ratio of voided volume to the total bladder capacity.

  Pre-BOTOX® Injection (Baseline)

• Length of Time of CIC Use in Clinical Practice after Treatment with 100-200U BOTOX®

  12 Weeks

Study Arms (1)

BOTOX®

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

Biological: onabotulinumtoxinA

Interventions

onabotulinumtoxinA BIOLOGICAL

onabotulinumtoxinA (BOTOX®)100 to 200 U

Also known as: Botulinum Toxin Type A, BOTOX®

BOTOX®

Eligibility Criteria

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

Study Population

Patients treated with BOTOX® for Idiopathic OAB in clinical practice.

You may qualify if:

• Patient with documented idiopathic OAB diagnosis
• Patient was treated with 100-200U of BOTOX® for OAB
• Urodynamics assessment within prior to first BOTOX® injection.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Allergan: lead

Study Sites (3)

Regional Urology

Shreveport, Louisiana, 71106, United States

Location

Chesapeake Urology Associates, LLC

Baltimore, Maryland, 21208, United States

Location

Virginia Urology

Richmond, Virginia, 23235, United States

Location

Related Links

• More Information

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

• Dana Fetterolf

  Allergan

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: February 2, 2017
• First Posted: February 6, 2017
• Study Start: May 12, 2017
• Primary Completion: September 9, 2019
• Study Completion: September 30, 2019
• Last Updated: February 5, 2020

Record last verified: 2020-02

Locations

US (3)