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Trial record 41 of 720 for:    Botulinum Toxins, Type A

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02590250
Recruitment Status : Completed
First Posted : October 29, 2015
Last Update Posted : March 26, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Urinary Incontinence Overactive Bladder Biological: botulinum toxin Type A

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Study Type : Observational
Actual Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : December 16, 2015
Actual Primary Completion Date : August 7, 2017
Actual Study Completion Date : August 7, 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Change from the baseline value of the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) [ Time Frame: at up to 4 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02590250


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

Additional Information:
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02590250     History of Changes
Other Study ID Numbers: 191622-140
First Posted: October 29, 2015    Key Record Dates
Last Update Posted: March 26, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Botulinum Toxins
Botulinum Toxins, Type A
Urinary Incontinence
Enuresis
Urinary Bladder, Overactive
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Urinary Bladder Diseases
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents