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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Renal Insufficiency; Urinary Incontinence; End Stage Renal Disease; Chronic Renal Disease; Bladder Dysfunction; Posterior Urethral Valve
• Intervention / Treatment: Other: Children with PUV

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: BIDAULT Valeska, MD; Phone Number: 04 27 85 57 94; Email: valeska.bidault@chu-lyon.fr

Study Locations

• France
  • Bron, France
    • Recruiting
    • Femme-Mère-Enfant Hospital
    • Contact: BIDAULT Valeska, MD; Phone Number: 04 27 85 57 94; Email: valeska.bidault@chu-lyon.fr
    • Contact: LO Claire, MD; Email: claire.lo@chu-lyon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Children with PUV will be selected inside the database of the pediatric surgery department of the Femme-Mère-Enfant Hospital in Lyon

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Score of the PedsQL 4.0 (Pediatric Quality of Life Inventory Version 4.0) Generic Core Scales	The 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.	At inclusion

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: BIDAULT Valeska, MD, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: May 28, 2024
• First Submitted That Met QC Criteria: May 28, 2024
• First Posted (Actual): June 3, 2024

Study Record Updates

• Last Update Posted (Actual): May 7, 2025
• Last Update Submitted That Met QC Criteria: May 5, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Adolescents; Family; Quality of life; Children; Posterior Urethral Valves
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Incontinence; Renal Insufficiency; Kidney Diseases; Kidney Failure, Chronic; Renal Insufficiency, Chronic
• Other Study ID Numbers: 69HCL24_0181

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No