Clinical trial NCT00221767: Medico-economical Impact of the Brindley Neurosurgical Technique in France
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Neurogenic Bladder Disorder
Paraplegia
Quadriplegia
Keywords: Neurogenic bladder
electric stimulation therapy
urinary tract infection
urinary incontinence
spinal cord injuries
spinal nerve roots
nonRandomized Controlled Trials
open Study
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2005-09-22
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 : 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.

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 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).

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Proportion of patients showing a complete voluntary (including electrostimulation) micturition
timeFrame: At 3 months, 6 months and at one year
Secondary outcomes:
measure: Bladder capacity (cystometry)
timeFrame: At 3 months, 6 months and after one year
measure: costs
timeFrame: At 3 months, 6 months, 9 months and at one year
measure: incidence of urinary infections
timeFrame: At visit 3, 6 and at one year
measure: incontinence
timeFrame: At 3 months, 6 months and at one year
measure: autonomic hyperreflexia (AHR)
timeFrame: At 3 months, 6 months, and at one year
measure: defecation
timeFrame: at 3 months, 6 months and at one year
measure: quality of life
timeFrame: at 6 months and at one year
measure: lower limbs spasticity
timeFrame: at 3 months, 6 months and at one year
Other outcomes:
Locations:
city: Bordeaux Cedex
country: France
facility: Neurochirurgie A - Hôpital Pellegrin , Place Amélie Raba-Léon
Study officials:
affiliation: University Hospital, Bordeaux
name: Jean-Rodolphe Vignes, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Bordeaux
name: Geneviève Chêne, Professor
role: STUDY_CHAIR
References: