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Study of the Quality of Life in School Aged-children With Posterior Urethral Valves

Quality of Life in School Aged-children With Posterior Urethral Valves

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06439862
Acronym
QUALIVUP
Enrollment
300
Registered
2024-06-03
Start date
2024-08-20
Completion date
2028-08-01
Last updated
2026-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Dysfunction, Chronic Renal Disease, End Stage Renal Disease, Posterior Urethral Valve, Quality of Life, Renal Insufficiency, Urinary Incontinence

Keywords

Quality of life, Posterior Urethral Valves, Children, Adolescents, Family

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).

Interventions

OTHERChildren with PUV

Male children aged 6 to 17 years old treated for PUV in their first year of life between 2006 and 2018 in Lyon, and managed in the Femme-Mère-Enfant Hospital in Lyon

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
6 Years to 17 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Score of the PedsQL 4.0 (Pediatric Quality of Life Inventory Version 4.0) Generic Core ScalesAt inclusionThe PedsQL 4.0 measures health-related quality of life in healthy children and those with acute and chronic health conditions. It consists of parallel child self-report and parent proxy-report formats, with 23 items and 5 response selections that range from "never" to "almost always". Parent proxy-report assesses parent's perceptions of their child's HRQOL. The items for each of the forms are essentially identical, differing in developmentally appropriate language, or first or third person tense. Items are reverse-scored and linearly trans-formed to a 0 to 100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0), so that higher scores indicate better HRQOL. Scale Scores are computed as the sum of the items divided by the number of items answered (this accounts for missing data). If more than 50% of the items in the scale are missing, the Scale Score is not computed.

Countries

France

Contacts

CONTACTBIDAULT Valeska, MD
valeska.bidault@chu-lyon.fr04 27 85 57 94
PRINCIPAL_INVESTIGATORBIDAULT Valeska, MD

Hospices Civils de Lyon

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 6, 2026