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NCT02590250 Clinical Trial

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

Urinary Incontinence Clinical Trial

Official title:
Evaluation of the Safety and Effectiveness of BOTOX® (Botulinum Toxin Type A) in the Treatment of Patients With Urinary Incontinence Due to Neurogenic Detrusor Overactivity or Overactive Bladder: A Phase IV Non-interventional Post-marketing Surveillance Study in India

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02590250
Other study ID # 191622-140
Secondary ID
Status Completed
Phase
First received October 27, 2015
Last updated March 23, 2018
Start date December 16, 2015
Est. completion date August 7, 2017

Study information
Verified date March 2018
Source Allergan
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a Post-Marketing Surveillance study in India to evaluate safety and efficacy of BOTOX® (Botulinum Toxin Type A) in the treatment of patients with urinary incontinence due to neurogenic detrusor overactivity or overactive bladder.

Recruitment information / eligibility
Status Completed
Enrollment 250
Est. completion date August 7, 2017
Est. primary completion date August 7, 2017
Accepts healthy volunteers No
Gender All
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

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
India Bodyline Hospitals Ahmedabad Gujarat
India Fortis Hospitals Bengaluru Karnataka
India Global Hospital Hyderabad Telangana
India Christian Medical College & Hospital Ludhiana Punjab
India Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute Mumbai Maharashtra
India Dr. Ram Manohar Lohia Hospital New Delhi Delhi
India Indian Spinal Injuries Centre New Delhi Delhi
India Fortis Escorts Heart Institute Okhla Road New Delhi
India NU Hospitals Padmanabha Nagar Banglore
India AMAI Charitable Trust's ACE Hospital and Research Centre Pune Maharashtra
India Inamdar Multispeciality Hospital Pune Maharashtra
India Christian Medical College and Hospital Vellore Tamil Nadu

Sponsors (1)
Lead Sponsor Collaborator
Allergan

Country where clinical trial is conducted

India, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from the baseline value of the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) at up to 4 months
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