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

March 23, 2018 updated by: Allergan

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Banglore
      • Padmanabha Nagar, Banglore, India, 560070
        • NU Hospitals
    • Delhi
      • New Delhi, Delhi, India, 110001
        • Dr. Ram Manohar Lohia Hospital
      • New Delhi, Delhi, India, 110070
        • Indian Spinal Injuries Centre
    • Gujarat
      • Ahmedabad, Gujarat, India, 380007
        • Bodyline Hospitals
    • Karnataka
      • Bengaluru, Karnataka, India, 560076
        • Fortis Hospitals
    • Maharashtra
      • Mumbai, Maharashtra, India, 400053
        • Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute
      • Pune, Maharashtra, India, 411040
        • Inamdar Multispeciality Hospital
      • Pune, Maharashtra, India, 411004
        • AMAI Charitable Trust's ACE Hospital and Research Centre
    • New Delhi
      • Okhla Road, New Delhi, India, 110025
        • Fortis Escorts Heart Institute
    • Punjab
      • Ludhiana, Punjab, India, 141008
        • Christian Medical College & Hospital
    • Tamil Nadu
      • Vellore, Tamil Nadu, India, 632004
        • Christian Medical College and Hospital
    • Telangana
      • Hyderabad, Telangana, India, 500004
        • Global Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.
Other Names:
  • BOTOX®
  • onabotulinumtoxinA

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Investigators

  • Study Director: Ahunna Ukah, Allergan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 16, 2015

Primary Completion (Actual)

August 7, 2017

Study Completion (Actual)

August 7, 2017

Study Registration Dates

First Submitted

October 27, 2015

First Submitted That Met QC Criteria

October 27, 2015

First Posted (Estimate)

October 29, 2015

Study Record Updates

Last Update Posted (Actual)

March 26, 2018

Last Update Submitted That Met QC Criteria

March 23, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 191622-140

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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