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

Completed

• Conditions: Urinary Incontinence; Urinary Bladder, Overactive
• Interventions: Biological: botulinum toxin Type A

• Registration Number: NCT02010788
• Lead Sponsor: Allergan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-10
• Study First Submitted QC: 2013-12-10
• Study First Posted: 2013-12-13
• Study Start: 2014-02
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-21
• Last Update Posted: 2016-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 523

Inclusion Criteria

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

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Exclusion Criteria

-None.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BOTOX®	botulinum toxin Type A	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of