Clinical trial NCT06439862: Study of the Quality of Life in School Aged-children With Posterior Urethral Valves
Official title: Quality of Life in School Aged-children With Posterior Urethral Valves
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Quality of Life
Posterior Urethral Valve
Renal Insufficiency
Chronic Renal Disease
End Stage Renal Disease
Bladder Dysfunction
Urinary Incontinence
Keywords: Quality of life
Posterior Urethral Valves
Children
Adolescents
Family
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2024-06-03
Enrollment: 300
Sex: MALE
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with PUV will be selected inside the database of the pediatric surgery department of the Femme-Mère-Enfant Hospital in Lyon

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 4.0 (PedsQL 4.0).


Eligibility criteria: Inclusion Criteria:

* Male patients and their parents/relatives
* Aged 6 to 17 years old
* Treated for PUV in their first year of life between 2006 and 2018
* Managed in the Femme-Mère-Enfant Hospital in Lyon

Exclusion Criteria:

* Children with pre-existing severe cognitive and physical disability (physician's rating) from other condition
* Children enable to complete QoL questionnaire due to mental or communication impairment

Primary outcomes:
measure: Score of the PedsQL 4.0 (Pediatric Quality of Life Inventory Version 4.0) Generic Core Scales
timeFrame: At inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Femme-Mère-Enfant Hospital
Study officials:
affiliation: Hospices Civils de Lyon
name: BIDAULT Valeska, MD
role: PRINCIPAL_INVESTIGATOR
References: