Medico-economical Impact of the Brindley Neurosurgical Technique in France

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Brief Title

Medico-economical Impact of the Brindley Neurosurgical Technique in France

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

Brief 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.
    

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


Primary Outcome

Proportion of patients showing a complete voluntary (including electrostimulation) micturition

Secondary Outcome

 Bladder capacity (cystometry)

Condition

Spinal Cord Injuries

Intervention

Brindley technique (bladder system)

Study Arms / Comparison Groups

 1
Description:  Brindley technique (bladder system)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

53

Start Date

June 2005

Completion Date

March 2010

Primary Completion Date

March 2010

Eligibility 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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Jean-Rodolphe Vignes, Doctor, , 

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT00221767

Organization ID

9415-04

Secondary IDs

2004-001

Responsible Party

Sponsor

Study Sponsor

University Hospital, Bordeaux

Collaborators

 Ministry of Health, France

Study Sponsor

Jean-Rodolphe Vignes, Doctor, Principal Investigator, University Hospital, Bordeaux


Verification Date

June 2012