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

Overactive Bladder Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00213577
• Other study ID #: 2003/112/HP
• Status: Terminated
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: March 23, 2015
• Start date: December 2003
• Est. completion date: October 2007

Study information

• Verified date: March 2015
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 80
• Est. completion date: October 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Neurogenic urinary incontinence with urodynamic overactivity resistant to anticholinergic

Exclusion Criteria:

• Pregnancy

• Bladder cancer

• Symptomatic urinary infection

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Drug:
• type A botulinum toxin

Locations

Country	Name	City	State
France	CHU-Rouen	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complete urinary continence at baseline, and days 30, 90, 180, and 360
Secondary	number of mictions or self catheterizations a day
Secondary	number of leakages, urgency adverse events
Secondary	guarding times
Secondary	urodynamics: bladder capacity, reflex volume, residual maximal capacity detrusor pressure, flow detrusor pressure