Quality of life in school-aged children treated for posterior urethral valves
Studies quality of life in school-aged children treated for a urinary tract birth defect.
Key facts
- Who runs it
- Hospices Civils de Lyon
- Where
- Bron, FranceSee the site
- Trial code
- Registry title
- Study of the Quality of Life in School Aged-children With Posterior Urethral Valves
- Status
- Recruiting
- People taking part
- 300 people, planned
- Started
- 20 Aug 2024
- Expected to end
- Aug 2028
- Type of study
- Observational
- Treatments tested
- Children with PUV
- Record updated
- 5 August 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for boys aged 6 to 17 who were treated for posterior urethral valves in their first year of life, and for their parents or relatives. It studies their quality of life.
- Age
- 6 to 17 years
- Sex
- Male only
- Disease stage
- Posterior urethral valves (PUV), treated in the first year of life between 2006 and 2018
- Earlier treatment
- Must have been treated for PUV in the first year of life, between 2006 and 2018
Main reasons for not taking part
- Severe cognitive and physical disability that existed before and comes from another condition
- Cannot fill in the quality of life questionnaire because of a mental or communication problem
The registry criteria, word for word
Show all 6 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 6 and 17 years old?
Where in France
- Femme-Mère-Enfant HospitalBron, FranceContact: BIDAULT Valeska, MDTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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).
Treatments tested
- Children with PUV
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Quality of Life in School Aged-children With Posterior Urethral Valves
- Plain-language title
- Quality of life in school-aged children treated for posterior urethral valvesGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06439862, who can take part
- Record updated
- 5 August 2026