NEUROTOX: Two Dosages of Type A Botulinic Toxin in Neurogenic Overactive Bladder
Phase 2
Terminated
- Conditions
- Overactive Bladder
- Registration Number
- NCT00213577
- Lead Sponsor
- University Hospital, Rouen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
- Neurogenic urinary incontinence with urodynamic overactivity resistant to anticholinergic
Exclusion Criteria
- Pregnancy
- Bladder cancer
- Symptomatic urinary infection
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method complete urinary continence at baseline, and days 30, 90, 180, and 360
- Secondary Outcome Measures
Name Time Method urodynamics: bladder capacity, reflex volume, residual maximal capacity detrusor pressure, flow detrusor pressure number of mictions or self catheterizations a day number of leakages, urgency adverse events guarding times
Trial Locations
- Locations (1)
CHU-Rouen
🇫🇷Rouen, France