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

September 13, 2005
June 13, 2012
June 2005
March 2010   (final data collection date for primary outcome measure)
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 ]
Proportion of patients showing a complete voluntary (including electrostimulation) micturition after one year
Complete list of historical versions of study NCT00221767 on ClinicalTrials.gov Archive Site
  • 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 ]
  • - Bladder capacity (cystometry)
  • - costs
  • - incidence of urinary infections
  • - incontinence
  • - autonomic hyperreflexia (AHR)
  • - defecation
  • - quality of life
  • - lower limbs spasticity
Not Provided
Not Provided
 
Medico-economical Impact of the Brindley Neurosurgical Technique in France
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.

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).

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Spinal Cord Injuries
  • Neurogenic Bladder Disorder
  • Paraplegia
  • Quadriplegia
Device: Brindley technique (bladder system)
Sacral posterior rhizotomies and implantation of Brindley device on sacral anterior roots
  • Experimental: 1
    Brindley technique (bladder system)
    Intervention: Device: Brindley technique (bladder system)
  • No Intervention: 2
    Reference group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
53
March 2010
March 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00221767
9415-04, 2004-001
Yes
University Hospital, Bordeaux
University Hospital, Bordeaux
Ministry of Health, France
Principal Investigator: Jean-Rodolphe Vignes, Doctor University Hospital, Bordeaux
Study Chair: Geneviève Chêne, Professor University Hospital, Bordeaux
University Hospital, Bordeaux
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP