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

Completed

• Conditions: Urinary Incontinence; Overactive Bladder
• Interventions: Biological: botulinum toxin Type A

• Registration Number: NCT02590250
• Lead Sponsor: Allergan

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-27
• Study First Submitted QC: 2015-10-27
• Study First Posted: 2015-10-29
• Study Start: 2015-12-16
• Primary Completion: 2017-08-07
• Study Completion: 2017-08-07
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-23
• Last Update Posted: 2018-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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

Arm && Interventions

Group	Intervention	Description
BOTOX®	botulinum toxin Type A	Patients who receive botulinum toxin Type A (BOTOX®) treatment for Neurogenic Detrusor Overactivity or Overactive Bladder as per local standard of care in clinical practice.

Primary Outcome Measures

Name	Time	Method
Change from the baseline value of the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)	at up to 4 months

Trial Locations

Locations (12)

Dr. Ram Manohar Lohia Hospital; 🇮🇳 New Delhi, Delhi, India

Bodyline Hospitals; 🇮🇳 Ahmedabad, Gujarat, India

Fortis Hospitals; 🇮🇳 Bengaluru, Karnataka, India

Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute; 🇮🇳 Mumbai, Maharashtra, India

Christian Medical College & Hospital; 🇮🇳 Ludhiana, Punjab, India

Christian Medical College and Hospital; 🇮🇳 Vellore, Tamil Nadu, India

Global Hospital; 🇮🇳 Hyderabad, Telangana, India

Indian Spinal Injuries Centre; 🇮🇳 New Delhi, Delhi, India

NU Hospitals; 🇮🇳 Padmanabha Nagar, Banglore, India

Inamdar Multispeciality Hospital; 🇮🇳 Pune, Maharashtra, India

AMAI Charitable Trust's ACE Hospital and Research Centre; 🇮🇳 Pune, Maharashtra, India

Fortis Escorts Heart Institute; 🇮🇳 Okhla Road, New Delhi, India