Standardized Prenatal Clinical Care for LUTO

NCT02315521 | Recruiting

• 1 other identifier: BCM H-35770
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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). The present study is a prospective registry that will evaluate and validate this standardized prenatal management for LUTO.

Conditions

Urethral Obstruction

Keywords

lower urinary tract obstruction; posterior urethral valves; urethral atresia; Prune Belly Syndrome; Megalo-urethra; Fetal renal function; Prenatal Diagnosis; Ultrasound

Outcome Measures

Primary Outcomes (1)

• Survival rate

  The survival rate from the prenatal period up to 24 months of life will be evaluated

  Survival rate since prenatal period to 24 months of life

Secondary Outcomes (3)

• Postnatal renal function at 6 months of life

  During neonatal period and at 6 months of life

• Postnatal renal function at 12 months of life

  During neonatal period and at 12 months of life

• Postnatal renal function at 24 months of life

  During neonatal period and at 24 months of life

Study Arms (4)

Group 1

Fetuses with LUTO before 18 weeks

Procedure: Fetal Intervention for LUTO

Group 2

Fetuses with LUTO between 18 and 30 weeks

Procedure: Fetal Intervention for LUTO

Group 3

Fetuses with LUTO between 30 and 34 weeks

Procedure: Fetal Intervention for LUTO

Group 4

Fetuses with LUTO after 34 weeks

Interventions

Fetal Intervention for LUTO PROCEDURE

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.

Also known as: Fetal vesico-amniotic shunting, Fetal cystoscopy

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 11 Weeks - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

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.

You may qualify if:

• \- Pregnant women whose fetuses have diagnosis of LUTO independently from the gestational age at diagnosis.

You may not qualify if:

• Presence of abnormal chromosomal/genetic disease
• Presence of other associated structural anomaly that is not part of LUTO.

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Texas Children's Hospital - Pavilion for Women

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Urethral Obstruction; Prune Belly Syndrome

Condition Hierarchy (Ancestors)

Urethral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Michael Belfort, MD PHD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael A Belfort, MD PHD

CONTACT

832-826-7375; belfort@bcm.edu

Rebecca M Johnson, BA

CONTACT

832-826-7451; rj2@bcm.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairman, Department of Obstetrics and Gynecology

Study Record Dates

• First Submitted: December 9, 2014
• First Posted: December 12, 2014
• Study Start: December 1, 2014
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: November 14, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)