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

Last updated: May 5, 2025
Sponsor: Hospices Civils de Lyon
Overall Status: Active - Recruiting

Phase

N/A

Condition

Urinary Incontinence

Genitourinary Prolapse

Nephropathy

Treatment

Children with PUV

Clinical Study ID

NCT06439862
69HCL24_0181
  • Ages 6-17
  • Male

Study 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

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

Exclusion Criteria:

  • Children with pre-existing severe cognitive and physical disability (physician'srating) from other condition

  • Children enable to complete QoL questionnaire due to mental or communicationimpairment

Study Design

Total Participants: 300
Treatment Group(s): 1
Primary Treatment: Children with PUV
Phase:
Study Start date:
August 20, 2024
Estimated Completion Date:
August 31, 2026

Connect with a study center

  • Femme-Mère-Enfant Hospital

    Bron,
    France

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.