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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
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

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.

Exclusion Criteria

-None.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Number of Participants with Adverse Events and Adverse Drug Reactions4 Months
International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) Total Score4 Months
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Asan Medical Center

🇰🇷

Seoul, Korea, Republic of

Asan Medical Center
🇰🇷Seoul, Korea, Republic of

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