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

Tracking Information
First Submitted Date ICMJE	September 13, 2005
First Posted Date ICMJE	September 22, 2005
Last Update Posted Date	June 14, 2012
Study Start Date ICMJE	June 2005
Actual Primary Completion Date	March 2010 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: April 15, 2009)	Proportion of patients showing a complete voluntary (including electrostimulation) micturition [ Time Frame: At 3 months, 6 months and at one year ]
Original Primary Outcome Measures ICMJE; (submitted: September 13, 2005)	Proportion of patients showing a complete voluntary (including electrostimulation) micturition after one year
Change History	Complete list of historical versions of study NCT00221767 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: April 15, 2009)	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 ]
Original Secondary Outcome Measures ICMJE; (submitted: September 13, 2005)	- Bladder capacity (cystometry); - costs; - incidence of urinary infections; - incontinence; - autonomic hyperreflexia (AHR); - defecation; - quality of life; - lower limbs spasticity
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Medico-economical Impact of the Brindley Neurosurgical Technique in France
Official Title ICMJE	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
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).
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
Condition ICMJE	Spinal Cord Injuries; Neurogenic Bladder Disorder; Paraplegia; Quadriplegia
Intervention ICMJE	Device: Brindley technique (bladder system); Sacral posterior rhizotomies and implantation of Brindley device on sacral anterior roots
Study Arms	Experimental: 1 Brindley technique (bladder system) Intervention: Device: Brindley technique (bladder system); No Intervention: 2 Reference group
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: April 15, 2009)	53
Original Enrollment ICMJE; (submitted: September 13, 2005)	99
Actual Study Completion Date	March 2010
Actual Primary Completion Date	March 2010 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	France
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00221767
Other Study ID Numbers ICMJE	9415-04; 2004-001
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	University Hospital, Bordeaux
Study Sponsor ICMJE	University Hospital, Bordeaux
Collaborators ICMJE	Ministry of Health, France
Investigators ICMJE	Principal Investigator: Jean-Rodolphe Vignes, Doctor University Hospital, Bordeaux Study Chair: Geneviève Chêne, Professor University Hospital, Bordeaux
PRS Account	University Hospital, Bordeaux
Verification Date	June 2012
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP