search
Back to results

NEUROTOX: Two Dosages of Type A Botulinic Toxin in Neurogenic Overactive Bladder

Primary Purpose

Overactive Bladder

Status
Terminated
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
type A botulinum toxin
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring overactive neurogenic bladder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Neurogenic urinary incontinence with urodynamic overactivity resistant to anticholinergic Exclusion Criteria: Pregnancy Bladder cancer Symptomatic urinary infection

Sites / Locations

  • CHU-Rouen

Outcomes

Primary Outcome Measures

complete urinary continence at baseline, and days 30, 90, 180, and 360

Secondary Outcome Measures

number of mictions or self catheterizations a day
number of leakages, urgency adverse events
guarding times
urodynamics: bladder capacity, reflex volume, residual maximal capacity detrusor pressure, flow detrusor pressure

Full Information

First Posted
September 13, 2005
Last Updated
March 23, 2015
Sponsor
University Hospital, Rouen
search

1. Study Identification

Unique Protocol Identification Number
NCT00213577
Brief Title
NEUROTOX: Two Dosages of Type A Botulinic Toxin in Neurogenic Overactive Bladder
Official Title
Evaluation of the Efficacy and Tolerance of 2 Dosages of Type A Botulinic Toxin in Neurogenic Areactive Bladder Resistant to Oral Medical Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Terminated
Why Stopped
the study has concluded normally;
Study Start Date
December 2003 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Rouen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine the efficacy and tolerance of 2 dosages (750 versus 500 units) of the Dysport type A botulinic toxin for patient suffering from neurogenic urinary incontinence by an overactive bladder and the failure of anticholinergic drugs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
Keywords
overactive neurogenic bladder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
type A botulinum toxin
Primary Outcome Measure Information:
Title
complete urinary continence at baseline, and days 30, 90, 180, and 360
Secondary Outcome Measure Information:
Title
number of mictions or self catheterizations a day
Title
number of leakages, urgency adverse events
Title
guarding times
Title
urodynamics: bladder capacity, reflex volume, residual maximal capacity detrusor pressure, flow detrusor pressure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Neurogenic urinary incontinence with urodynamic overactivity resistant to anticholinergic Exclusion Criteria: Pregnancy Bladder cancer Symptomatic urinary infection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe GRISE, MD
Organizational Affiliation
CHU de Rouen
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU-Rouen
City
Rouen
ZIP/Postal Code
76031
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
20674149
Citation
Grise P, Ruffion A, Denys P, Egon G, Chartier Kastler E. Efficacy and tolerability of botulinum toxin type A in patients with neurogenic detrusor overactivity and without concomitant anticholinergic therapy: comparison of two doses. Eur Urol. 2010 Nov;58(5):759-66. doi: 10.1016/j.eururo.2010.06.035. Epub 2010 Jul 3.
Results Reference
derived

Learn more about this trial

NEUROTOX: Two Dosages of Type A Botulinic Toxin in Neurogenic Overactive Bladder

We'll reach out to this number within 24 hrs