Actively Recruiting

Age: 6Years - 17Years
MALE
NCT06439862

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

Led by Hospices Civils de Lyon · Updated on 2025-05-07

300

Participants Needed

1

Research Sites

101 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 6Years - 17Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male patients and their parents or relatives
  • Aged 6 to 17 years old
  • Treated for posterior urethral valves in their first year of life between 2006 and 2018
  • Managed in the Femme-Mère-Enfant Hospital in Lyon
Not Eligible

You will not qualify if you...

  • Children with severe cognitive or physical disability from other conditions as rated by a physician
  • Children unable to complete quality of life questionnaire due to mental or communication impairments

AI-Screening

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Trial Site Locations

Total: 1 location

1

Femme-Mère-Enfant Hospital

Bron, Bron, France

Actively Recruiting

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Research Team

B

BIDAULT Valeska, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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