Status:
UNKNOWN
EVALUATION OF THE SAFETY AND EFFICACY OF ADJUSTABLE CONTINENT THERAPY IN CHILDREN WITH SPINAL DYSRAPHISM.
Lead Sponsor:
Assistance Publique Hopitaux De Marseille
Conditions:
Neurogenic Bladder Due to Spinal Dysraphism
Eligibility:
All Genders
5-18 years
Phase:
NA
Brief Summary
Urinary continence is still a difficult goal to achieve in neurogenic bladder patients. Conservative treatment of neurogenic urinary incontinence using clean intermittent catheterization in conjunctio...
Eligibility Criteria
Inclusion
- Boys and girls \> 5 years with spinal dysraphism (occult or open)
- Neurogenic sphincteric incontinence (leak point pressure \< 45 cm d'H20, open bladder neck during filling, urinary incontinence)
- Normal renal function (eGFR \> 90ml/min)
- No (or stable) upper urinary tract dilatation in ultrasound
- In case no compliante bladder ( bladder capacity \< 50% for the age) a concomitant injection of botox endoscopically will be performed
Exclusion
- under 5 years with an acquired neurogenic bladder
- renal insufficiency (acute or chronic)
- evolutive deterioration of the upper urinary tract (hydronephrosis)
- active systemic or urinary tract infections
- unmanageable detrusor instability
- reduced bladder compliance
- residual volume greater than 100 ml after voiding
- bleeding disorders
- urethral stenosis
- who refused CIC
- patent sacral bedsore
Key Trial Info
Start Date :
December 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03351634
Start Date
December 30 2017
End Date
October 30 2024
Last Update
November 24 2017
Active Locations (1)
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1
Assistance Publique Hopitaux de Marseille
Marseille, France, 13354