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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02601287

Enrollment

168

Registered

2015-11-10

Start date

2015-11-30

Completion date

2016-07-31

Last updated

2016-07-21

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

Conditions

Overactive Bladder, Urinary Incontinence

Brief summary

This is a safety and efficacy study of BOTOX® (Botulinum Toxin Type A) in the Treatment of Adult Korean Patients with Urinary Incontinence due to Neurogenic Detrusor Overactivity or Overactive Bladder.

Interventions

BIOLOGICALBotulinum Toxin Type A

Botulinum Toxin Type A into detrusor muscle on Day 1

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Urinary incontinence as a result of neurogenic overactive bladder due to spinal cord injury or multiple sclerosis * Symptoms of urge urinary incontinence, urgency, and frequency due to overactive bladder

Exclusion criteria

* Myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis * Use of botulinum toxin therapy of any serotype in the 3 months prior to screening * Has acute urinary retention who do not routinely perform clean intermittent self-catheterization (CIC)

Design outcomes

Primary

Measure	Time frame
Change from the baseline in the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) total score	Baseline, Day 28

Countries

South Korea

Outcome results

None listed

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