Evaluation of Safety and Efficacy of Botulinum Toxin Type A (BOTOX®) to Treat Urinary Incontinence Due to Neurogenic Detrusor Overactivity or Overactive Bladder in Korea

NCT02010788 | Completed

• 1 other identifier: 191622-134
• Study Type: observational
• Target: 523
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a Post-Marketing Surveillance study in Korea to evaluate the safety and efficacy of botulinum toxin Type A to treat urinary incontinence in patients with neurogenic detrusor overactivity (NDO) or overactive bladder (OAB) not adequately controlled by anticholinergic drugs.

Conditions

Urinary Incontinence; Urinary Bladder, Overactive

Outcome Measures

Primary Outcomes (2)

• Number of Participants with Adverse Events and Adverse Drug Reactions

  4 Months

• International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) Total Score

  4 Months

Study Arms (1)

BOTOX®

Patients who receive botulinum toxin Type A (BOTOX®) treatment for Neurogenic Detrusor Overactivity or Overactive Bladder as per local standard of care in clinical practice.

Biological: botulinum toxin Type A

Interventions

botulinum toxin Type A BIOLOGICAL

Botulinum toxin Type A treatment for Neurogenic Detrusor Overactivity or Overactive Bladder as per local standard of care in clinical practice.

Also known as: BOTOX®, onabotulinumtoxinA

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 with urinary incontinence due to NDO or OAB.

You may qualify if:

• Patients with urinary incontinence due to NDO or OAB treated with BOTOX® as per local standard of care in clinical practice.

You may not qualify if:

• None.

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

Related Links

• More Information

MeSH Terms

Conditions

Urinary Incontinence; Urinary Bladder, Overactive

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Urination Disorders; 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; Urinary Bladder Diseases

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: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2013
• First Posted: December 13, 2013
• Study Start: February 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: September 22, 2016

Record last verified: 2016-09

Locations

KR (1)