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

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.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injuries; Quadriplegia; Paraplegia; Neurogenic Bladder Disorder
• Intervention / Treatment: Device: Brindley technique (bladder system)

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).

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux Cedex, France, 33076
    • Neurochirurgie A - Hôpital Pellegrin , Place Amélie Raba-Léon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Brindley technique (bladder system)	Device: Brindley technique (bladder system); Sacral posterior rhizotomies and implantation of Brindley device on sacral anterior roots
No Intervention: 2; Reference group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients showing a complete voluntary (including electrostimulation) micturition	At 3 months, 6 months and at one year

Secondary Outcome Measures

Outcome Measure	Time Frame
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	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
defecation	at 3 months, 6 months and at one year
quality of life	at 6 months and at one year
lower limbs spasticity	at 3 months, 6 months and at one year

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Collaborators: Ministry of Health, France
• Investigators: Principal Investigator: Jean-Rodolphe Vignes, Doctor, University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start: June 1, 2005
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 22, 2005

Study Record Updates

• Last Update Posted (Estimate): June 14, 2012
• Last Update Submitted That Met QC Criteria: June 13, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: spinal cord injuries; urinary incontinence; urinary tract infection; Neurogenic bladder; electric stimulation therapy; spinal nerve roots; nonRandomized Controlled Trials; open Study
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Urologic Diseases; Neurologic Manifestations; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Paralysis; Spinal Cord Injuries; Urinary Bladder, Neurogenic; Quadriplegia; Paraplegia; Urinary Bladder Diseases
• Other Study ID Numbers: 9415-04; 2004-001