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NCT02010788 Clinical Trial

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

Urinary Incontinence Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02010788
Other study ID # 191622-134
Secondary ID
Status Completed
Phase N/A
First received December 10, 2013
Last updated September 21, 2016
Start date February 2014
Est. completion date July 2016

Study information
Verified date September 2016
Source Allergan
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 523
Est. completion date July 2016
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Korea, Republic of Asan Medical Center Seoul

Sponsors (1)
Lead Sponsor Collaborator
Allergan

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants with Adverse Events and Adverse Drug Reactions 4 Months No
Primary International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) Total Score 4 Months No
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