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

NCT ID: NCT02590250

Last Updated: 2018-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-16

Study Completion Date

2017-08-07

Brief Summary

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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

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Conditions

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Urinary Incontinence Overactive Bladder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

botulinum toxin Type A

Intervention Type BIOLOGICAL

Botulinum toxin Type A treatment for Neurogenic Detrusor Overactivity or Overactive Bladder as per local standard of care in clinical practice.

Interventions

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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.

Intervention Type BIOLOGICAL

Other Intervention Names

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BOTOX® onabotulinumtoxinA

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ahunna Ukah

Role: STUDY_DIRECTOR

Allergan

Locations

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NU Hospitals

Padmanabha Nagar, Banglore, India

Site Status

Bodyline Hospitals

Ahmedabad, Gujarat, India

Site Status

Fortis Hospitals

Bengaluru, Karnataka, India

Site Status

Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute

Mumbai, Maharashtra, India

Site Status

AMAI Charitable Trust's ACE Hospital and Research Centre

Pune, Maharashtra, India

Site Status

Inamdar Multispeciality Hospital

Pune, Maharashtra, India

Site Status

Dr. Ram Manohar Lohia Hospital

New Delhi, National Capital Territory of Delhi, India

Site Status

Indian Spinal Injuries Centre

New Delhi, National Capital Territory of Delhi, India

Site Status

Fortis Escorts Heart Institute

Okhla Road, New Delhi, India

Site Status

Christian Medical College & Hospital

Ludhiana, Punjab, India

Site Status

Christian Medical College and Hospital

Vellore, Tamil Nadu, India

Site Status

Global Hospital

Hyderabad, Telangana, India

Site Status

Countries

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India

Related Links

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Other Identifiers

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191622-140

Identifier Type: -

Identifier Source: org_study_id

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