Observational Study of Botulinum Toxin Type A in Patients With Urinary Incontinence Associated With Overactive Bladder

Completed

• Conditions: Urinary Bladder, Overactive; Urinary Bladder, Neurogenic

• Registration Number: NCT02673047
• Lead Sponsor: Allergan

Brief Summary

This study will describe the prescription conditions of botulinum toxin Type A (Botox®) injection for the treatment of urinary incontinence due to neurogenic detrusor overactivity (NDO) or idiopathic overactive bladder (IOAB) as per standard of care in clinical practice in France.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-01
• Study First Submitted QC: 2016-02-01
• Study First Posted: 2016-02-03
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-21
• Last Update Posted: 2016-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 474

Inclusion Criteria

-Patients who receive a Botox® injection for urinary incontinence.

Exclusion Criteria

-Patients not residing in France.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Target Patients Prescribed Botox® in Clinical Practice	Day 1

Secondary Outcome Measures

Name	Time	Method
Total Number of Botox® Cycles in Non-naive Patients (previously received Botox®)	Day 1
Length of Botox® Treatment in Non-naive Patients	Day 1
Time Since Last Botox® Injection in Non-naive Patients	Day 1
Characteristics of Injector Sites (Locations)	Day 1
Treatments Previously Prescribed	Day 1
Number of Sites Injected	Day 1
Total Dose of Botox® Used	Day 1
Types of Anaesthesia and Antibiotic Prophylaxis Used	Day 1
Cytobacteriological Examination of the Urine	Day 1
Characteristics of Injector Physicians	Day 1
Characteristics of Patients	Day 1
Number of Patients by Pathology History	Day 1
Number of Patients by Medical and Surgical History	Day 1
Reduction of Number of Daily Urinary Incontinence Episodes in Non-naive Patients	Day 1
Percentage of Continent Patients in Non-naive Patients	Day 1
Number of Adverse Events during the Visit	Day 1

Trial Locations

Locations (50)

Site D'Aix En Provence; 🇫🇷 AIX en Provence, France

CL Toulouse Lautrec; 🇫🇷 Albi, France

CHU Angers; 🇫🇷 Angers Cedex 01, France

CH Angouleme; 🇫🇷 Angouleme Cedex 9, France

CH Avranches Granville; 🇫🇷 Avranches, France

CH Bagnols Sur Ceze; 🇫🇷 Bagnols-Sur-Ceze, France

CH Belfort; 🇫🇷 Belfort Cedex, France

CHU Besancon; 🇫🇷 Besancon Cedex, France

CHU Bordeaux; 🇫🇷 Bordeaux Cedex, France

CL Saint Augustin; 🇫🇷 Bordeaux, France

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