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

Urinary Incontinence Clinical Trial

— GRACE  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02161159
• Other study ID #: MAF/AGN/NS/OAB/002
• Status: Completed
• Phase: N/A
• First received: June 9, 2014
• Last updated: March 8, 2016
• Start date: June 2014
• Est. completion date: January 2016

Study information

• Verified date: March 2016
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 515
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Urinary Bladder, Overactive
• Urinary Incontinence

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

Germany,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Patients Who have Greatly Improved or Improved on the 4-Point Treatment Benefit Scale (TBS)		Baseline, Week 12	No
Primary	Change From Baseline in Number of Urinary Incontinence Episodes		Baseline, Week 12	No
Secondary	Time to Re-Injection of BOTOX®		12 Months	No
Secondary	Number of Nocturia Episodes		12 Months	No
Secondary	Usage of Incontinence Support Products		12 Months	No
Secondary	Percentage of Patients Who Have at Least a 50% Reduction in Urinary Incontinence and Urinary Urgency Incontinence		Baseline, 12 Months	No