Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06439862
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-03
First Post:
2024-05-28
Brief Title:
Study of the Quality of Life in School Aged-children With Posterior Urethral Valves
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Quality of Life in School Aged-children With Posterior Urethral Valves
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
QUALIVUP
Brief Summary:
Posterior urethral valves PUV are the most common congenital obstructive lesion of the urethra affecting from 1 per 3000 to 1 per 8000 live births Valve ablation usually resolves the obstruction in PUV but patients still may suffer of deterioration in renal and urinary functions
Renal insufficiency is the most feared long-term complication Up to 50 of the patients will develop chronic kidney disease CKD and up to 20 will develop end-stage renal disease ESRD and ultimately will require kidney transplantation PUV is the first urological cause of ESRD Progression towards CKD depends on febrile urinary tract infections UTIs severity of a vesicoureteral reflux and bladder dysfunction
Bladder dysfunction is due to an overactive and small poorly compliant bladder during infancy Detrusor overactivity usually decreases in childhood and bladder capacity increases The most common symptom of this bladder dysfunction is urinary incontinence 60 of children are continent at the age of 5 years old and 90 at 10 years old In case of persistent bladder dysfunction medical treatment anticholinergics alpha-blockers may be introduced or even intermittent catheterizations
Current scientific literature has very few studies on quality of life QoL in patients with PUV mostly in adult patients and very small cohorts Men treated for PUV in childhood had a good quality of life compared to the normative population except for sleeping eating and sexual activity It seemed that the more severe the urological and nephrological functions were the lower the QoL was Children were only asked about intermittent urinary catheterization and family point of view has never been collected However QoL and long-term evolution represent the first concerns of parents-to-be in prenatal counseling or after diagnosis in an infant with PUV
Hence the aim of the study is to investigate the quality of life in school-aged children who had been treated for PUV in their first year of life as measured by the Pediatric Quality of Life Inventory Version 40 PedsQL 40
Renal insufficiency is the most feared long-term complication Up to 50 of the patients will develop chronic kidney disease CKD and up to 20 will develop end-stage renal disease ESRD and ultimately will require kidney transplantation PUV is the first urological cause of ESRD Progression towards CKD depends on febrile urinary tract infections UTIs severity of a vesicoureteral reflux and bladder dysfunction
Bladder dysfunction is due to an overactive and small poorly compliant bladder during infancy Detrusor overactivity usually decreases in childhood and bladder capacity increases The most common symptom of this bladder dysfunction is urinary incontinence 60 of children are continent at the age of 5 years old and 90 at 10 years old In case of persistent bladder dysfunction medical treatment anticholinergics alpha-blockers may be introduced or even intermittent catheterizations
Current scientific literature has very few studies on quality of life QoL in patients with PUV mostly in adult patients and very small cohorts Men treated for PUV in childhood had a good quality of life compared to the normative population except for sleeping eating and sexual activity It seemed that the more severe the urological and nephrological functions were the lower the QoL was Children were only asked about intermittent urinary catheterization and family point of view has never been collected However QoL and long-term evolution represent the first concerns of parents-to-be in prenatal counseling or after diagnosis in an infant with PUV
Hence the aim of the study is to investigate the quality of life in school-aged children who had been treated for PUV in their first year of life as measured by the Pediatric Quality of Life Inventory Version 40 PedsQL 40
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None