Medico-economical Impact of the Brindley Neurosurgical Technique in France

Spinal Cord Injuries Clinical Trial

— BRINDLEY  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00221767
• Other study ID #: 9415-04
• Secondary ID: 2004-001
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: June 13, 2012
• Start date: June 2005
• Est. completion date: March 2010

Study information

• Verified date: June 2012
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Neurogenic Bladder Disorder
• Paraplegia
• Quadriplegia
• Spinal Cord Injuries
• Urinary Bladder Diseases
• Urinary Bladder, Neurogenic

Intervention

Device:
• Brindley technique (bladder system)
Sacral posterior rhizotomies and implantation of Brindley device on sacral anterior roots

Locations

Country	Name	City	State
France	Neurochirurgie A - Hôpital Pellegrin , Place Amélie Raba-Léon	Bordeaux Cedex

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients showing a complete voluntary (including electrostimulation) micturition		At 3 months, 6 months and at one year	No
Secondary	Bladder capacity (cystometry)		At 3 months, 6 months and after one year	No
Secondary	costs		At 3 months, 6 months, 9 months and at one year	No
Secondary	incidence of urinary infections		At visit 3, 6 and at one year	No
Secondary	incontinence		At 3 months, 6 months and at one year	No
Secondary	autonomic hyperreflexia (AHR)		At 3 months, 6 months, and at one year	No
Secondary	defecation		at 3 months, 6 months and at one year	No
Secondary	quality of life		at 6 months and at one year	No
Secondary	lower limbs spasticity		at 3 months, 6 months and at one year	No