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
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
1 other identifier
observational
250
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2015
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 27, 2015
CompletedFirst Posted
Study publicly available on registry
October 29, 2015
CompletedStudy Start
First participant enrolled
December 16, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 7, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 7, 2017
CompletedMarch 26, 2018
March 1, 2018
1.6 years
October 27, 2015
March 23, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Change from the baseline value of the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)
at up to 4 months
Study Arms (1)
BOTOX®
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.
Interventions
Botulinum toxin Type A treatment for Neurogenic Detrusor Overactivity or Overactive Bladder as per local standard of care in clinical practice.
Eligibility Criteria
Patients with urinary incontinence (due to NDO, eg, as a result of SCI or MS, or due to OAB) who have an inadequate response to or are intolerant of an anticholinergic medication
You may qualify if:
- Patients with urinary incontinence due to NDO or OAB treated with BOTOX® as per local standard of care in clinical practice.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (12)
NU Hospitals
Padmanabha Nagar, Banglore, 560070, India
Bodyline Hospitals
Ahmedabad, Gujarat, 380007, India
Fortis Hospitals
Bengaluru, Karnataka, 560076, India
Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute
Mumbai, Maharashtra, 400053, India
AMAI Charitable Trust's ACE Hospital and Research Centre
Pune, Maharashtra, 411004, India
Inamdar Multispeciality Hospital
Pune, Maharashtra, 411040, India
Dr. Ram Manohar Lohia Hospital
New Delhi, National Capital Territory of Delhi, 110001, India
Indian Spinal Injuries Centre
New Delhi, National Capital Territory of Delhi, 110070, India
Fortis Escorts Heart Institute
Okhla Road, New Delhi, 110025, India
Christian Medical College & Hospital
Ludhiana, Punjab, 141008, India
Christian Medical College and Hospital
Vellore, Tamil Nadu, 632004, India
Global Hospital
Hyderabad, Telangana, 500004, India
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ahunna Ukah
Allergan
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 27, 2015
First Posted
October 29, 2015
Study Start
December 16, 2015
Primary Completion
August 7, 2017
Study Completion
August 7, 2017
Last Updated
March 26, 2018
Record last verified: 2018-03