Spinal Cord InjuriesBRINDLEYNCT00221767
Medico-economical Impact of the Brindley Neurosurgical Technique in France
A study testing Brindley technique (bladder system) in people with Spinal Cord Injuries and Neurogenic Bladder Disorder, run by University Hospital, Bordeaux at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries, Neurogenic Bladder Disorder, Paraplegia
- What is being tested?
- Brindley technique (bladder system)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2005to Mar 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Neurochirurgie A - Hôpital Pellegrin , Place Amélie Raba-Léon
Bordeaux, 33076
About this study
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
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.
Read the 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).
- Being tested
- Brindley technique (bladder system)
- Keywords
- Neurogenic bladder, electric stimulation therapy, urinary tract infection, urinary incontinence, spinal cord injuries, spinal nerve roots, nonRandomized Controlled Trials, open Study
- Medical subject headings
- Spinal Cord Injuries, Urinary Bladder, Neurogenic, Paraplegia, Quadriplegia, Urinary Tract Infections, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brindley technique (bladder system)Device
Sacral posterior rhizotomies and implantation of Brindley device on sacral anterior roots
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Brindley technique (bladder system) Receives: Device: Brindley technique (bladder system) |
| 2 | No intervention | Reference group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients showing a complete voluntary (including electrostimulation) micturition
Measured: At 3 months, 6 months and at one year
Secondary outcomes (8)
Bladder capacity (cystometry)
Measured: At 3 months, 6 months and after one year
costs
Measured: At 3 months, 6 months, 9 months and at one year
incidence of urinary infections
Measured: At visit 3, 6 and at one year
incontinence
Measured: At 3 months, 6 months and at one year
autonomic hyperreflexia (AHR)
Measured: At 3 months, 6 months, and at one year
defecation
Measured: at 3 months, 6 months and at one year
quality of life
Measured: at 6 months and at one year
lower limbs spasticity
Measured: at 3 months, 6 months and at one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJun 2005
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Jean-Rodolphe Vignes, Doctor, Principal investigator, University Hospital, BordeauxGeneviève Chêne, Professor, Study chair, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00221767
- Sponsor's protocol ID
- 9415-04
- Other IDs
- 2004-001
- Acronym
- BRINDLEY
- Status last verified
- Jun 2012
- First submitted
- 13 Sep 2005
- Last updated
- 14 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00221767
- Acronym / sponsor ID
- BRINDLEY / 9415-04
- Keywords
- Neurogenic bladder, electric stimulation therapy, urinary tract infection, urinary incontinence, spinal cord injuries, spinal nerve roots, nonRandomized Controlled Trials, open Study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Jun 2005
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Brindley technique (bladder system)Brindley technique (bladder system) |
| 2 | No intervention | –Reference group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brindley technique (bladder system)Sacral posterior rhizotomies and implantation of Brindley device on sacral anterior roots | Device | 1 |
Primary outcome
Proportion of patients showing a complete voluntary (including electrostimulation) micturition
Time frame: At 3 months, 6 months and at one year
8 secondary outcomes
Bladder capacity (cystometry)
Time frame: At 3 months, 6 months and after one year
costs
Time frame: At 3 months, 6 months, 9 months and at one year
incidence of urinary infections
Time frame: At visit 3, 6 and at one year
incontinence
Time frame: At 3 months, 6 months and at one year
autonomic hyperreflexia (AHR)
Time frame: At 3 months, 6 months, and at one year
defecation
Time frame: at 3 months, 6 months and at one year
quality of life
Time frame: at 6 months and at one year
lower limbs spasticity
Time frame: at 3 months, 6 months and at one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Rodolphe Vignes, Doctor principal investigator
University Hospital, Bordeaux
Geneviève Chêne, Professor study chair
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brindley technique (bladder system) in people with Spinal Cord Injuries and Neurogenic Bladder Disorder, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients showing a complete voluntary (including electrostimulation) micturition (time frame: At 3 months, 6 months and at one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2012.