Medico-economical Impact of the Brindley Neurosurgical Technique in France

NCT00221767 | Completed DMC

• 2 other identifiers: 9415-042004-001
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries; Neurogenic Bladder Disorder; Paraplegia; Quadriplegia

Keywords

Neurogenic bladder; electric stimulation therapy; urinary tract infection; urinary incontinence; spinal cord injuries; spinal nerve roots; nonRandomized Controlled Trials; open Study

Outcome Measures

Primary Outcomes (1)

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

  At 3 months, 6 months and at one year

Secondary Outcomes (8)

• Bladder capacity (cystometry)

  At 3 months, 6 months and after one year

• costs

  At 3 months, 6 months, 9 months and at one year

• incidence of urinary infections

  At visit 3, 6 and at one year

• incontinence

  At 3 months, 6 months and at one year

• autonomic hyperreflexia (AHR)

  At 3 months, 6 months, and at one year

Study Arms (2)

1

EXPERIMENTAL

Brindley technique (bladder system)

Device: Brindley technique (bladder system)

2

NO INTERVENTION

Reference group

Interventions

Brindley technique (bladder system) DEVICE

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

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• Ministry of Health, France: collaborator

Study Sites (1)

Neurochirurgie A - Hôpital Pellegrin , Place Amélie Raba-Léon

Bordeaux, 33076, France

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Urinary Bladder, Neurogenic; Paraplegia; Quadriplegia; Urinary Tract Infections; Urinary Incontinence

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Neurologic Manifestations; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Paralysis; Infections; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations

Study Officials

• Jean-Rodolphe Vignes, Doctor

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

• Geneviève Chêne, Professor

  University Hospital, Bordeaux

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 22, 2005
• Study Start: June 1, 2005
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: June 14, 2012

Record last verified: 2012-06

Locations

FR (1)