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

Primary Purpose

Spinal Cord Injuries, Neurogenic Bladder Disorder, Paraplegia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Brindley technique (bladder system)
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Spinal Cord Injuries focused on measuring Neurogenic bladder, electric stimulation therapy, urinary tract infection, urinary incontinence, spinal cord injuries, spinal nerve roots, nonRandomized Controlled Trials, open Study

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Neurochirurgie A - Hôpital Pellegrin , Place Amélie Raba-Léon

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

Brindley technique (bladder system)

Reference group

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Bladder capacity (cystometry)
costs
incidence of urinary infections
incontinence
autonomic hyperreflexia (AHR)
defecation
quality of life
lower limbs spasticity

Full Information

First Posted
September 13, 2005
Last Updated
June 13, 2012
Sponsor
University Hospital, Bordeaux
Collaborators
Ministry of Health, France
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1. Study Identification

Unique Protocol Identification Number
NCT00221767
Brief Title
Medico-economical Impact of the Brindley Neurosurgical Technique in France
Acronym
BRINDLEY
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
Collaborators
Ministry of Health, France

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Brindley technique (bladder system)
Arm Title
2
Arm Type
No Intervention
Arm Description
Reference group
Intervention Type
Device
Intervention Name(s)
Brindley technique (bladder system)
Intervention Description
Sacral posterior rhizotomies and implantation of Brindley device on sacral anterior roots
Primary Outcome Measure Information:
Title
Proportion of patients showing a complete voluntary (including electrostimulation) micturition
Time Frame
At 3 months, 6 months and at one year
Secondary Outcome Measure Information:
Title
Bladder capacity (cystometry)
Time Frame
At 3 months, 6 months and after one year
Title
costs
Time Frame
At 3 months, 6 months, 9 months and at one year
Title
incidence of urinary infections
Time Frame
At visit 3, 6 and at one year
Title
incontinence
Time Frame
At 3 months, 6 months and at one year
Title
autonomic hyperreflexia (AHR)
Time Frame
At 3 months, 6 months, and at one year
Title
defecation
Time Frame
at 3 months, 6 months and at one year
Title
quality of life
Time Frame
at 6 months and at one year
Title
lower limbs spasticity
Time Frame
at 3 months, 6 months and at one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Rodolphe Vignes, Doctor
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Geneviève Chêne, Professor
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Study Chair
Facility Information:
Facility Name
Neurochirurgie A - Hôpital Pellegrin , Place Amélie Raba-Léon
City
Bordeaux Cedex
ZIP/Postal Code
33076
Country
France

12. IPD Sharing Statement

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Medico-economical Impact of the Brindley Neurosurgical Technique in France

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