Status:
COMPLETED
Medico-economical Impact of the Brindley Neurosurgical Technique in France
Lead Sponsor:
University Hospital, Bordeaux
Collaborating Sponsors:
Ministry of Health, France
Conditions:
Spinal Cord Injuries
Neurogenic Bladder Disorder
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Bladder dysfunction is a major problem in patients with complete spinal cord lesions. For patients presenting incontinence or risk for kidney, two major conventional alternatives are possible : conser...
Detailed Description
Background : In paraplegic and tetraplegic patients with suprasacral lesion, bladder overactivity leads to incontinence and is frequently associated with detrusor-sphincter dyssynergia which is respon...
Eligibility Criteria
Inclusion
- Patient with a complete suprasacral spinal cord injury proved by a clinical exam (perineal reflex preserved) and MRI.
- Clinically stable spinal cord injury for at least 6 months (verified by MRI)
- Patient with an overactive neurogenic bladder (urodynamic testing), incontinence (specific patient diary) and/or risk for the bladder/kidney (intravenous urography, cystography)
- signed informed consent
Exclusion
- Injured sacral medullar centers or injured sacral roots
- Non contractile bladder
- Pregnancy or breast feeding
- Contraindication linked to neurostimulator implantation: unwounded cutaneous lesion, prolonged septic state, blood coagulation deficiency, known allergy to one component of the implanted medical device (silicone, platinum, iridium)
- Incapacity to receive an informed consent, incapacity to follow all the study schedule,
- patient not protected by social security
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT00221767
Start Date
June 1 2005
End Date
March 1 2010
Last Update
June 14 2012
Active Locations (1)
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1
Neurochirurgie A - Hôpital Pellegrin , Place Amélie Raba-Léon
Bordeaux, France, 33076