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What does life feel like for children with a rare birth defect? a new study asks

NCT ID NCT06439862

Knowledge-focused Sponsor: Hospices Civils de Lyon Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time

Summary

This study aims to understand the quality of life of school-aged children who were treated for posterior urethral valves (PUV) in their first year of life. PUV is a rare birth defect that can affect kidney and bladder function. Researchers will use a standard questionnaire called PedsQL 4.0 to measure how these children feel about their physical, emotional, social, and school life, and will also ask parents for their perspective. The goal is to gather information that can help improve care and support for children with this condition.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could provide a clearer picture of how posterior urethral valves affect children's daily lives, helping families and doctors make more informed decisions about care and support.
What could go wrong
This is an observational study, so it won't test a new treatment. The results may not apply to all children with this condition, and quality of life is subjective, varying from child to child.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2024

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

6 to 17 years

Sex

Male participants only

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

chronic kidney disease chronic renal failure syndrome end stage renal failure kidney failure posterior urethral valve urinary bladder disorder Urinary Incontinence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bladder dysfunction Chronic renal disease End-stage renal disease Posterior urethral valve Quality of life Renal insufficiency Urinary incontinence

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Femme-Mère-Enfant Hospital

    RECRUITING

    Bron, Bron, France

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