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Medico-Economical Impact of the Brindley Neurosurgical Technique in France
This study is currently recruiting participants.
Verified by University Hospital, Bordeaux, June 2007
Sponsors and Collaborators: University Hospital, Bordeaux
Ministry of Health, France
Information provided by: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT00221767
  Purpose

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 Intervention
Spinal Cord Injuries
Neurogenic Bladder Disorder
Paraplegia
Quadriplegia
Device: Brindley technique (bladder system)

Genetics Home Reference related topics: Charcot-Marie-Tooth disease hereditary neuropathy with liability to pressure palsies
MedlinePlus related topics: Bladder Diseases Spinal Cord Injuries Urinary Incontinence Urinary Tract Infections
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • Proportion of patients showing a complete voluntary (including electrostimulation) micturition [ Time Frame: after one year ]

Secondary Outcome Measures:
  • Bladder capacity (cystometry)
  • costs
  • incidence of urinary infections
  • incontinence
  • autonomic hyperreflexia (AHR)
  • defecation
  • quality of life
  • lower limbs spasticity

Estimated Enrollment: 99
Study Start Date: June 2005
Estimated Study Completion Date: May 2008
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00221767

Contacts
Contact: Jean-Rodolphe Vignes, Doctor 33 (0) 5 56 79 55 43 jean-rodolphe.vignes@chu-bordeaux.fr
Contact: Eric Donois 33(0) 5 56 79 55 43 eric.donois@chu-bordeaux.fr

Locations
France
Neurochirurgie A - Hôpital Pellegrin , Place Amélie Raba-Léon Recruiting
Bordeaux Cedex, France, 33076
Contact: Jean-Rodolphe Vignes, Doctor     33 (0) 56 79 55 73     jean-rodolphe.vignes@chu-bordeaux.fr    
Sponsors and Collaborators
University Hospital, Bordeaux
Ministry of Health, France
Investigators
Principal Investigator: Jean-Rodolphe Vignes, Doctor University Hospital, Bordeaux
Study Chair: Geneviève Chêne, Professor University Hospital, Bordeaux
  More Information

No publications provided

Study ID Numbers: 9415-04, 2004-001
Study First Received: September 13, 2005
Last Updated: June 28, 2007
ClinicalTrials.gov Identifier: NCT00221767  
Health Authority: France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Bordeaux:
Neurogenic bladder
electric stimulation therapy
urinary tract infection
urinary incontinence
spinal cord injuries
spinal nerve roots
nonRandomized Controlled Trials
open Study

Study placed in the following topic categories:
Spinal Cord Diseases
Roussy Levy hereditary areflexic dystasia
Urinary Tract Infections
Paraplegia
Disorders of Environmental Origin
Quadriplegia
Spinal Cord Injuries
Signs and Symptoms
Urologic Diseases
Neuromuscular Diseases
Hereditary Motor and Sensory Neuropathies
Urinary Bladder, Neurogenic
Cystocele
Charcot-Marie-Tooth Disease
Urinary Bladder Diseases
Wounds and Injuries
Central Nervous System Diseases
Trauma, Nervous System
Nerve Compression Syndromes
Paralysis
Tomaculous neuropathy
Peripheral Nervous System Diseases
Neurologic Manifestations
Urinary Incontinence
Charcot Marie Tooth disease

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on February 11, 2009