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

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.

Completed

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Key information

Conditions

Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Overactive Bladder Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

NU Hospitals, Padmanabha Nagar, Banglore, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Botulinum toxin type A

Biological

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 outcomes

Change from the baseline value of the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)

Time frame: at up to 4 months

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Official study 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

Important dates

Study start: 2015
Primary completion: 2017
Study completion: 2017
First posted: Oct 29, 2015
Registry last updated: Mar 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed