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New fetal procedure aims to save babies with rare bladder blockage

NCT ID NCT02315521

Disease control Sponsor: Baylor College of Medicine 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a step-by-step treatment plan for fetuses with lower urinary tract obstruction (LUTO), a condition where a blockage prevents urine from leaving the bladder. Doctors will use either a shunt to drain urine or a tiny scope to clear the blockage. The goal is to see if this approach improves survival and kidney function up to 2 years after birth. The study enrolls 50 pregnant women whose fetuses have LUTO.

What this could mean

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

Active substance
Fetal vesico-amniotic shunting or fetal cystoscopy
What this could lead to
If successful, this could establish a reliable treatment plan to improve survival and kidney health in babies with LUTO.
What could go wrong
This is a small, early-stage registry study with only 50 participants, so results may not apply to everyone. The procedures carry risks like infection or preterm labor.

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 50 people

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

Start date

Dec 2014

Expected to finish

Nov 2026

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

All pregnant women referred to our Fetal Center with confirmed diagnosis of fetal LUTO. The diagnosis of fetal LUTO is based on the presence of enlarged bladder and bilateral hydronephrosis.

Ages

11 weeks to 2 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: \- Pregnant women whose fetuses have diagnosis of LUTO independently from the gestational age at diagnosis. Exclusion Criteria: * Presence of abnormal chromosomal/genetic disease * Presence of other associated structural anomaly that is not part of LUTO.

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Conditions

The condition(s) this trial relates to.

lower urinary tract obstruction, congenital prune belly syndrome urethral obstruction urinary tract obstruction

As listed by the trial registrant

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

Urethral obstruction

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

  • Texas Children's Hospital - Pavilion for Women

    RECRUITING

    Houston, Texas, 77030, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.