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

Sponsor
Hospices Civils de Lyon
Study ID
NCT06439862
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
MALE
Age
6 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Children with PUV — OTHER
    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

Study Details

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).

Key Dates

First listed
Jun 3, 2024
Start date
Aug 20, 2024
Status verified
May 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
300 participants (estimated)

Primary Outcome Measure

Score of the PedsQL 4.0 (Pediatric Quality of Life Inventory Version 4.0) Generic Core Scales [ Time Frame: At inclusion ]

Central Contacts

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