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
- Conditions
- Urinary IncontinenceOveractive Bladder
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 250
- Patients with urinary incontinence due to NDO or OAB treated with BOTOX® as per local standard of care in clinical practice.
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (12)
NU Hospitals
🇮🇳Padmanabha Nagar, Banglore, India
Dr. Ram Manohar Lohia Hospital
🇮🇳New Delhi, Delhi, India
Indian Spinal Injuries Centre
🇮🇳New Delhi, Delhi, India
Bodyline Hospitals
🇮🇳Ahmedabad, Gujarat, India
Fortis Hospitals
🇮🇳Bengaluru, Karnataka, India
Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute
🇮🇳Mumbai, Maharashtra, India
AMAI Charitable Trust's ACE Hospital and Research Centre
🇮🇳Pune, Maharashtra, India
Inamdar Multispeciality Hospital
🇮🇳Pune, Maharashtra, India
Fortis Escorts Heart Institute
🇮🇳Okhla Road, New Delhi, India
Christian Medical College & Hospital
🇮🇳Ludhiana, Punjab, India
Scroll for more (2 remaining)NU Hospitals🇮🇳Padmanabha Nagar, Banglore, India