BRINDLEY
Prospective Comparative Multicenter Study on the Medico-economical Impact of the Brindley Technique in the Management of Neurogenic Bladder in Patients With Injured Spinal Cord
Sponsor study identifier
Secondary identifiers
interventional
53
1 country
1
Study Start
June 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2010
Actual (reported)Study Completion
March 2010
Actual (reported)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 : conservative therapies (muscarinic receptor antagonists, vanilloids drugs and botulinum toxin in association with catheterization) and surgical techniques intervening in the nervous and urinary system. Among these last alternatives, the Brindley technique (anterior sacral root stimulation with posterior rhizotomy) is the only technique allowing for the restauration of bladder function, continence, and micturition. The purpose of the study is to compare the Brindley technique with the first conventional approach in France from a medical and economical point of view.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2010
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2005
Date type not reportedThis date has not been verified as actual or estimated.
September 13, 2005
Actual (reported)September 22, 2005
Actual (reported)March 2010
Actual (reported)March 2010
Actual (reported)Proportion of patients showing a complete voluntary (including electrostimulation) micturition
At 3 months, 6 months and at one year
Bladder capacity (cystometry)
At 3 months, 6 months and after one year
costs
At 3 months, 6 months, 9 months and at one year
incidence of urinary infections
Brindley technique (bladder system)
Reference group
Sacral posterior rhizotomies and implantation of Brindley device on sacral anterior roots
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Neurochirurgie A - Hôpital Pellegrin , Place Amélie Raba-Léon
Bordeaux, 33076, France
Jean-Rodolphe Vignes, Doctor
University Hospital, Bordeaux
Geneviève Chêne, Professor
University Hospital, Bordeaux
53 participants (actual enrollment reported by the registry).
First Submitted
September 13, 2005
First Posted
September 22, 2005
Study Start
June 2005
Date type not reportedThis date has not been verified as actual or estimated.
Personal Exoskeleton or Manual Wheelchair: a Comparison of Performance and Satisfaction in Activities of Daily Living Among People With Spinal Cord Injuries, Using the SCED Methodology.
At visit 3, 6 and at one year
incontinence
At 3 months, 6 months and at one year
autonomic hyperreflexia (AHR)
At 3 months, 6 months, and at one year
Contact the study team to confirm eligibility.
Primary Completion
March 2010
Actual (reported)Study Completion
March 2010
Actual (reported)Last Updated
June 14, 2012
Record last verified: 2012-06
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Source: ClinicalTrials.gov.
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