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

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT00221767
First received: September 13, 2005
Last updated: June 13, 2012
Last verified: June 2012
  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)

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

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 53
Study Start Date: June 2005
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00221767

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

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT00221767     History of Changes
Other Study ID Numbers: 9415-04, 2004-001
Study First Received: September 13, 2005
Last Updated: June 13, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Spinal Cord Injuries
Urinary Bladder, Neurogenic
Paraplegia
Quadriplegia
Urinary Bladder Diseases
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Neurologic Manifestations
Urologic Diseases
Signs and Symptoms
Paralysis

ClinicalTrials.gov processed this record on October 16, 2014