Urethral ObstructionNCT02315521
Standardized Prenatal Clinical Care for LUTO
An observational study of Urethral Obstruction, run by Baylor College of Medicine at 1 site in United States.
Trial summary
The investigators propose a standardized prenatal management, based on the scientific evidence published in the literature, to manage prenatally fetuses with lower urinary tract obstruction (LUTO). Read more about this study
- Who is it for?
- Ages 11 weeks to 2 years
- Conditions the study is for
- Urethral Obstruction
- What is being tested?
- Fetal Intervention for LUTO
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Dec 2027
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 weeks to 2 years
- All sexes
- No healthy volunteers
- Child
Study population: 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.
Who may be able to join
- Pregnant women whose fetuses have diagnosis of LUTO independently from the gestational age at diagnosis.
Who cannot join
- Presence of abnormal chromosomal/genetic disease
- Presence of other associated structural anomaly that is not part of LUTO.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Texas Children's Hospital - Pavilion for Women
Houston, Texas, 77030
Michael Belfort, MD PhD, 832-826-7375, belfort@bcm.edu
Rebecca J Johnson, BA, 832-826-7451, rj2@bcm.edu
About this study
Official title: Validation of the Standardized Prenatal Clinical Management of Fetuses With Lower Urinary Tract Obstruction (LUTO)
The investigators propose a standardized prenatal management, based on the scientific evidence published in the literature, to manage prenatally fetuses with lower urinary tract obstruction (LUTO). The present study is a prospective registry that will evaluate and validate this standardized prenatal management for LUTO.
Read the detailed description
Patients with LUTO will come for clinical evaluation as part of the standard clinical care at the our Fetal Center. The standardized prenatal management of plan for fetuses with LUTO is described in details bellow.
All pregnant women carrying fetuses with LUTO are assigned to the nurse coordinator and the prenatal records are obtained. The multidisciplinary team (maternal-fetal intervention team, pediatric urologists, pediatric nephrologist, neonatologist, genetic counselors and fetal cardiologists) will be notified. A one-day visit is planned with the following: 1. a fetal comprehensive ultrasound is scheduled for the confirmation of the diagnosis, investigation of associated anomalies and evaluation of prognostic factors; 2. a genetic counseling is performed and fetal invasive tests (FISH/fetal karyotype/fetal CMA) are offered to the patients; 3. Fetal echocardiogram is also performed to evaluate the presence of associated cardiac anomalies and the fetal cardiac function; 4. A consultation with the Fetal Intervention team (maternal-fetal specialty) is scheduled as well. Additionally, maternal and fetal samples (maternal blood, amniotic fluid, fetal blood, and fetal urine) will be collected as part of the standardized clinical management. We plan to investigate the analysis of those samples, and to also collect more samples for banking to be used in future studies.
If the gestational age is less than 18 weeks and isolated LUTO is confirmed on ultrasonography, patient is giving the option for prenatal expectant management, or fetal intervention or termination of pregnancy. If patient elects to proceed with fetal intervention, vesico-amniotic shunting is performed and patient is followed by ultrasound once a week. In case the shunt migrates or seems to be obstructed, we will offer repeating the procedure to the patient. If patient elects to proceed with expectant management, follow-up will be every 4 weeks. Delivery date and type of delivery depend on the obstetrical indications.
For fetuses at gestational age greater than 18 and less than 30 weeks, if oligohydramnios is present, investigation of fetal renal biochemistry is offered. In case of favorable fetal renal biochemistry, vesico-amniotic shunt is offered as a fetal therapeutic intervention. In case the fetal urinary biochemistry is considered not favorable, then we will repeat the urinary examination in 24 hours. If the fetal urinary biochemistry is still not favorable, we will repeat the examination for the last time (maximum of 3 times). If it is still not favorable, then fetal vesico-amniotic shunt is not offered. However, if a fetal urinary examination reveals improvement favorable urinary biochemistry), fetal vesico-amniotic shunting is considered. Prenatal follow-up and delivery follow the same algorithm described previously.
If gestational age is greater than 30 weeks and less than 34 weeks and isolated LUTO is diagnosed, fetal intervention is offered if oligohydramnios is present. If no oligohydramnios is identified, no fetal intervention is offered and patient is followed until delivery. Delivery date and type of delivery depend on the obstetrical indications.
For those fetuses with gestational age greater than 34 weeks, if oligohydramnios is present, pre-term delivery is indicated. If a normal amount of amniotic fluid is seen, patient is followed weekly by ultrasound examination and delivery is at term.
Fetuses with other associated anomalies independent from the gestational age will undergo further investigation with fetal magnetic resonance imaging and evaluation by the multidisciplinary team.
All infants with LUTO will have the same routine standard clinical care. All infants with LUTO are evaluated postnatally by the pediatric urology and nephrology services and may need surgical intervention. At birth, the clinical evaluation will include a renal ultrasound, voiding cysto-urethrogram (VCUG) as well as clinical laboratory examinations such as serum creatinine, sodium, calcium, potassium and chloride, and a urine analysis will be performed as part of the standard clinical care. The infant will be followed every 6 months up until 24 months of life, and then annually afterwards. Information from these routine examinations will be collected and documented.
- Conditions
- Urethral Obstruction
- Being tested
- Fetal Intervention for LUTO
- Keywords
- lower urinary tract obstruction, posterior urethral valves, urethral atresia, Prune Belly Syndrome, Megalo-urethra, Fetal renal function, Prenatal Diagnosis, Ultrasound
- Medical subject headings
- Urethral Obstruction, Prune Belly Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fetal Intervention for LUTOProcedure or surgery
Also called Fetal vesico-amniotic shunting, Fetal cystoscopy
Fetal vesico-amniotic shunting placement consists in placing a shunt (stent) percutaneously from fetal bladder to the amniotic cavity under ultrasound guidance.
Fetal cystoscopy will be performed using a thin scope that will be introduced to the fetal bladder for evaluation of the cause of the obstruction and ablation of the posterior urethral valves.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Fetuses with LUTO before 18 weeks Receives: Procedure: Fetal Intervention for LUTO | |
| Group 2 | Fetuses with LUTO between 18 and 30 weeks Receives: Procedure: Fetal Intervention for LUTO | |
| Group 3 | Fetuses with LUTO between 30 and 34 weeks Receives: Procedure: Fetal Intervention for LUTO | |
| Group 4 | Fetuses with LUTO after 34 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate
The survival rate from the prenatal period up to 24 months of life will be evaluated
Measured: Survival rate since prenatal period to 24 months of life
Secondary outcomes (3)
Postnatal renal function at 6 months of life
Renal function during neonatal period and at 6 months of life will be evaluated by analyzing the serum creatinine, weight and height, renal function, bladder function, lung disease, need for dialysis and transplantation, arterial hypertension, incontinence and developmental delay
Measured: During neonatal period and at 6 months of life
Postnatal renal function at 12 months of life
Renal function during neonatal period and at 12 months of life will be evaluated by analyzing the serum creatinine, weight and height, renal function, bladder function, lung disease, need for dialysis and transplantation, arterial hypertension, incontinence and developmental delay
Measured: During neonatal period and at 12 months of life
Postnatal renal function at 24 months of life
Renal function during neonatal period and at 24 months of life will be evaluated by analyzing the serum creatinine, weight and height, renal function, bladder function, lung disease, need for dialysis and transplantation, arterial hypertension, incontinence and developmental delay
Measured: During neonatal period and at 24 months of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urethral ObstructionStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael A Belfort, Baylor College of Medicine
- Investigators
- Michael Belfort, MD PHD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02315521
- Sponsor's protocol ID
- BCM H-35770
- Status last verified
- Sep 2026
- First submitted
- 9 Dec 2014
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Standardized Prenatal Clinical Management of Fetuses With Lower Urinary Tract Obstruction (LUTO)
- ClinicalTrials.gov ID
- NCT02315521
- Acronym / sponsor ID
- BCM H-35770
- Conditions
- Urethral Obstruction
- Keywords
- lower urinary tract obstruction, posterior urethral valves, urethral atresia, Prune Belly Syndrome, Megalo-urethra, Fetal renal function, Prenatal Diagnosis, Ultrasound
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 12 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators propose a standardized prenatal management, based on the scientific evidence published in the literature, to manage prenatally fetuses with lower urinary tract obstruction (LUTO). The present study is a prospective registry that will evaluate and validate this standardized prenatal management for LUTO.
Detailed description
Patients with LUTO will come for clinical evaluation as part of the standard clinical care at the our Fetal Center. The standardized prenatal management of plan for fetuses with LUTO is described in details bellow.
All pregnant women carrying fetuses with LUTO are assigned to the nurse coordinator and the prenatal records are obtained. The multidisciplinary team (maternal-fetal intervention team, pediatric urologists, pediatric nephrologist, neonatologist, genetic counselors and fetal cardiologists) will be notified. A one-day visit is planned with the following: 1. a fetal comprehensive ultrasound is scheduled for the confirmation of the diagnosis, investigation of associated anomalies and evaluation of prognostic factors; 2. a genetic counseling is performed and fetal invasive tests (FISH/fetal karyotype/fetal CMA) are offered to the patients; 3. Fetal echocardiogram is also performed to evaluate the presence of associated cardiac anomalies and the fetal cardiac function; 4. A consultation with the Fetal Intervention team (maternal-fetal specialty) is scheduled as well. Additionally, maternal and fetal samples (maternal blood, amniotic fluid, fetal blood, and fetal urine) will be collected as part of the standardized clinical management. We plan to investigate the analysis of those samples, and to also collect more samples for banking to be used in future studies.
If the gestational age is less than 18 weeks and isolated LUTO is confirmed on ultrasonography, patient is giving the option for prenatal expectant management, or fetal intervention or termination of pregnancy. If patient elects to proceed with fetal intervention, vesico-amniotic shunting is performed and patient is followed by ultrasound once a week. In case the shunt migrates or seems to be obstructed, we will offer repeating the procedure to the patient. If patient elects to proceed with expectant management, follow-up will be every 4 weeks. Delivery date and type of delivery depend on the obstetrical indications.
For fetuses at gestational age greater than 18 and less than 30 weeks, if oligohydramnios is present, investigation of fetal renal biochemistry is offered. In case of favorable fetal renal biochemistry, vesico-amniotic shunt is offered as a fetal therapeutic intervention. In case the fetal urinary biochemistry is considered not favorable, then we will repeat the urinary examination in 24 hours. If the fetal urinary biochemistry is still not favorable, we will repeat the examination for the last time (maximum of 3 times). If it is still not favorable, then fetal vesico-amniotic shunt is not offered. However, if a fetal urinary examination reveals improvement favorable urinary biochemistry), fetal vesico-amniotic shunting is considered. Prenatal follow-up and delivery follow the same algorithm described previously.
If gestational age is greater than 30 weeks and less than 34 weeks and isolated LUTO is diagnosed, fetal intervention is offered if oligohydramnios is present. If no oligohydramnios is identified, no fetal intervention is offered and patient is followed until delivery. Delivery date and type of delivery depend on the obstetrical indications.
For those fetuses with gestational age greater than 34 weeks, if oligohydramnios is present, pre-term delivery is indicated. If a normal amount of amniotic fluid is seen, patient is followed weekly by ultrasound examination and delivery is at term.
Fetuses with other associated anomalies independent from the gestational age will undergo further investigation with fetal magnetic resonance imaging and evaluation by the multidisciplinary team.
All infants with LUTO will have the same routine standard clinical care. All infants with LUTO are evaluated postnatally by the pediatric urology and nephrology services and may need surgical intervention. At birth, the clinical evaluation will include a renal ultrasound, voiding cysto-urethrogram (VCUG) as well as clinical laboratory examinations such as serum creatinine, sodium, calcium, potassium and chloride, and a urine analysis will be performed as part of the standard clinical care. The infant will be followed every 6 months up until 24 months of life, and then annually afterwards. Information from these routine examinations will be collected and documented.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Procedure: Fetal Intervention for LUTOFetuses with LUTO before 18 weeks |
| Group 2 | – | Procedure: Fetal Intervention for LUTOFetuses with LUTO between 18 and 30 weeks |
| Group 3 | – | Procedure: Fetal Intervention for LUTOFetuses with LUTO between 30 and 34 weeks |
| Group 4 | – | –Fetuses with LUTO after 34 weeks |
Who may qualify
- Ages
- 11 weeks to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 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.
Key inclusion criteria (1 listed)
- Pregnant women whose fetuses have diagnosis of LUTO independently from the gestational age at diagnosis.
Key exclusion criteria (2 listed)
- Presence of abnormal chromosomal/genetic disease
- Presence of other associated structural anomaly that is not part of LUTO.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fetal Intervention for LUTOAlso: Fetal vesico-amniotic shunting, Fetal cystoscopyFetal vesico-amniotic shunting placement consists in placing a shunt (stent) percutaneously from fetal bladder to the amniotic cavity under ultrasound guidance. Fetal cystoscopy will be performed using a thin scope that will be introduced to the fetal bladder for evaluation of the cause of the obstruction and ablation of the posterior urethral valves. | Procedure or surgery | Group 1, Group 2, Group 3 |
Primary outcome
Survival rate
Time frame: Survival rate since prenatal period to 24 months of life
The survival rate from the prenatal period up to 24 months of life will be evaluated
3 secondary outcomes
Postnatal renal function at 6 months of life
Time frame: During neonatal period and at 6 months of life
Postnatal renal function at 12 months of life
Time frame: During neonatal period and at 12 months of life
Postnatal renal function at 24 months of life
Time frame: During neonatal period and at 24 months of life
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Belfort, MD PHD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urethral Obstruction, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael A Belfort, MD PHD (832-826-7375, belfort@bcm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival rate (time frame: Survival rate since prenatal period to 24 months of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.