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Medico-economical Impact of the Brindley Neurosurgical Technique in France

NCT00221767 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2012-06-14

No results posted yet for this study

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.

Conditions

  • Spinal Cord Injuries
  • Neurogenic Bladder Disorder
  • Paraplegia
  • Quadriplegia

Interventions

DEVICE

Brindley technique (bladder system)

Sacral posterior rhizotomies and implantation of Brindley device on sacral anterior roots

Sponsors & Collaborators

  • Ministry of Health, France

    collaborator OTHER_GOV

  • University Hospital, Bordeaux

    lead OTHER

Principal Investigators

  • Jean-Rodolphe Vignes, Doctor · University Hospital, Bordeaux

  • Geneviève Chêne, Professor · University Hospital, Bordeaux

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-30
Primary Completion
2010-03-31
Completion
2010-03-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00221767 on ClinicalTrials.gov