Medico-economical Impact of the Brindley Neurosurgical Technique in France (BRINDLEY)

• Proportion of patients showing a complete voluntary (including electrostimulation) micturition [ Time Frame: At 3 months, 6 months and at one year ] [ Designated as safety issue: No ]
  

• Bladder capacity (cystometry) [ Time Frame: At 3 months, 6 months and after one year ] [ Designated as safety issue: No ]
  
• costs [ Time Frame: At 3 months, 6 months, 9 months and at one year ] [ Designated as safety issue: No ]
  
• incidence of urinary infections [ Time Frame: At visit 3, 6 and at one year ] [ Designated as safety issue: No ]
  
• incontinence [ Time Frame: At 3 months, 6 months and at one year ] [ Designated as safety issue: No ]
  
• autonomic hyperreflexia (AHR) [ Time Frame: At 3 months, 6 months, and at one year ] [ Designated as safety issue: No ]
  
• defecation [ Time Frame: at 3 months, 6 months and at one year ] [ Designated as safety issue: No ]
  
• quality of life [ Time Frame: at 6 months and at one year ] [ Designated as safety issue: No ]
  
• lower limbs spasticity [ Time Frame: at 3 months, 6 months and at one year ] [ Designated as safety issue: No ]
  

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).