Medico-economical Impact of the Brindley Neurosurgical Technique in France (BRINDLEY)
|ClinicalTrials.gov Identifier: NCT00221767|
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : June 14, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injuries Neurogenic Bladder Disorder Paraplegia Quadriplegia||Device: Brindley technique (bladder system)||Not Applicable|
Background : In paraplegic and tetraplegic patients with suprasacral lesion, bladder overactivity leads to incontinence and is frequently associated with detrusor-sphincter dyssynergia which is responsible for residual postvoiding (high infectious risk) and intravesical high pressure (risk for kidney). The Brindley technique allows to restore a voluntary voiding of the bladder and an effective continence. Electrodes are fixed to anterior sacral roots in order to obtain micturition. Posterior sacral root rhizotomy suppress detrusor and sphincter overactivity, improves continence and thus protects bladder and kidney (low pressure bladder filling). Currently in France, 100 new patients could benefit from this innovative technique among the 1000 patients with spinal cord injury
Objective :To compare the cost/effectiveness ratio of the Brindley technique approach to that of the reference group (muscarinic receptor antagonists + catheterization or reflex micturition)at one year, in patient with neurogenic bladder.
In this prospective, comparative, non-randomized, multicenter study, the eligible patients are included according to the following ratio : 2:1 (Brindley : Reference ). The complete suprasacral spinal cord injured patients with an overactive neurogenic bladder, incontinence and/or risk of kidney/bladder injury) are the population studied. The spinal cord injury must be clinically stable for at least 3 months.
primary outcome :Proportion of patients showing a complete voluntary (including electrostimulation) micturition after one year.
Secondary outcome : Bladder capacity (cystometry), costs, incidence of urinary infections, incontinence, autonomic hyperreflexia (AHR), defecation, quality of life, lower limbs spasticity.
Patient follow-up :Visits must be planned at 1, 3, 6, 9 and 12 months: A classical clinical exam and a specific exam (evaluation of AHR, Ashworth and Penn Score) at 6 and 12 months and the following complementary exams at 3, 6 and 12 months: urodynamic testing and intravenous urography, retrograde ureterocystography and bladder echography at 12 months.
Population size : A total number of 99 patients must be enrolled to achieve the fixed goals (66 patients in the Brindley group and 33 patients in the Reference group).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||53 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||June 2005|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||March 2010|
Brindley technique (bladder system)
Device: Brindley technique (bladder system)
Sacral posterior rhizotomies and implantation of Brindley device on sacral anterior roots
No Intervention: 2
- Proportion of patients showing a complete voluntary (including electrostimulation) micturition [ Time Frame: At 3 months, 6 months and at one year ]
- Bladder capacity (cystometry) [ Time Frame: At 3 months, 6 months and after one year ]
- costs [ Time Frame: At 3 months, 6 months, 9 months and at one year ]
- incidence of urinary infections [ Time Frame: At visit 3, 6 and at one year ]
- incontinence [ Time Frame: At 3 months, 6 months and at one year ]
- autonomic hyperreflexia (AHR) [ Time Frame: At 3 months, 6 months, and at one year ]
- defecation [ Time Frame: at 3 months, 6 months and at one year ]
- quality of life [ Time Frame: at 6 months and at one year ]
- lower limbs spasticity [ Time Frame: at 3 months, 6 months and at one year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00221767
|Neurochirurgie A - Hôpital Pellegrin , Place Amélie Raba-Léon|
|Bordeaux Cedex, France, 33076|
|Principal Investigator:||Jean-Rodolphe Vignes, Doctor||University Hospital, Bordeaux|
|Study Chair:||Geneviève Chêne, Professor||University Hospital, Bordeaux|