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OpenTrials
Completed

NCT Number: NCT02161159

An Observational Study of BOTOX® for the Management of Urinary Incontinence in Patients With Idiopathic Overactive Bladder

This study will evaluate real world pattern of use of BOTOX® in actual clinical practice in patients with idiopathic overactive bladder (iOAB) with urinary incontinence whose symptoms have not been adequately managed by oral anticholinergic therapy.

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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 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

David Brix, Bad Mergentheim, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • No prior treatment with botulinum toxin Type A for treatment of iOAB

Exclusion criteria

  • Treatment with any botulinum toxin Type A within 18 months

Treatment and study plan

Botulinum toxin type A

Biological

botulinum toxin Type A administered in accordance with physician standard practice.

Other names: BOTOX®, onabotulinumtoxinA

Primary outcomes

  1. Percentage of Patients Who have Greatly Improved or Improved on the 4-Point Treatment Benefit Scale (TBS)

    Time frame: Baseline, Week 12

  2. Change From Baseline in Number of Urinary Incontinence Episodes

    Time frame: Baseline, Week 12

Secondary outcomes

  1. Time to Re-Injection of BOTOX®

    Time frame: 12 Months

  2. Number of Nocturia Episodes

    Time frame: 12 Months

  3. Usage of Incontinence Support Products

    Time frame: 12 Months

  4. Percentage of Patients Who Have at Least a 50% Reduction in Urinary Incontinence and Urinary Urgency Incontinence

    Time frame: Baseline, 12 Months

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Acronym: GRACE

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jun 11, 2014
Registry last updated
Apr 18, 2016

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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