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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02010788

Enrollment

523

Registered

2013-12-13

Start date

2014-02-28

Completion date

2016-07-31

Last updated

2016-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Bladder, Overactive, Urinary Incontinence

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.

Interventions

BIOLOGICALbotulinum toxin Type A

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026