Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00221767
Status:
COMPLETED
Last Update Posted:
2012-06-14
First Post:
2005-09-13
Brief Title:
Medico-economical Impact of the Brindley Neurosurgical Technique in France
Sponsor:
University Hospital Bordeaux
Organization:
University Hospital Bordeaux
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BRINDLEY
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
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 costeffectiveness ratio of the Brindley technique approach to that of the reference group muscarinic receptor antagonists catheterization or reflex micturitionat 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 21 Brindley Reference The complete suprasacral spinal cord injured patients with an overactive neurogenic bladder incontinence andor risk of kidneybladder 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
Objective To compare the costeffectiveness ratio of the Brindley technique approach to that of the reference group muscarinic receptor antagonists catheterization or reflex micturitionat 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 21 Brindley Reference The complete suprasacral spinal cord injured patients with an overactive neurogenic bladder incontinence andor risk of kidneybladder 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2004-001 | None | None | None |