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OpenTrials
Completed

NCT Number: NCT02072928

Study of Botulinum Toxin Type A (BOTOX®) to Treat Urinary Incontinence From Neurogenic Detrusor Overactivity in Belgium

This study will evaluate the impact of BOTOX® treatment on anticholinergic drug use in patients with urinary incontinence from Neurogenic Detrusor Overactivity (NDO) due to spinal injury or Multiple Sclerosis (MS) who are prescribed BOTOX® as standard of care in clinical practice.

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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 Pathological Conditions, Signs and Symptoms Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UZA, Edegem, Belgium

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients prescribed BOTOX® for urine incontinence from NDO due to spinal injury or MS as standard of care in clinical practice in Belgium
  • Previous treatment with anticholinergic drugs ineffective
  • Last BOTOX® treatment ≥18 months.

Exclusion criteria

  • Diagnosis of urinary incontinence less than 9 months.
  • No anticholinergic drug use in the last 9 months.

Treatment and study plan

Botulinum toxin type A

Biological

botulinum toxin Type A (BOTOX®) prescribed as standard of care in clinical practice.

Other names: onabotulinumtoxinA, BOTOX®

Primary outcomes

  1. Change From Baseline in Anticholinergic Drug Use

    Time frame: Baseline, 9 Months

    Anticholinergic drug use was collected the 9 months before the baseline Botox® treatment and the 9 months following the baseline Botox® treatment. Total anticholinergic drug use in the 9 months following the baseline Botox® treatment is noted.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 27, 2014
Registry last updated
Dec 15, 2017

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.

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