Fetal Cystoscopy for Severe Lower Urinary Tract Obstruction

NCT ID: NCT03281798

Last Updated: 2025-03-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2027-08-01

Brief Summary

The purpose of the study is to study the outcomes of maternal and fetal patients who are undergoing fetal intervention for severe isolated lower urinary tract obstruction (LUTO).

Conditions

Lower Urinary Tract Obstructive Syndrome; Lower Urinary Tract Obstruction, Congenital; Bladder Outlet Obstruction; Bladder Outflow Obstruction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fetal Cystoscopy Group

Participants in this group will receive the fetal cystoscopy procedure around 16 weeks 0 days to 25 weeks and 6 days of gestation.

Group Type: EXPERIMENTAL

Fetoscopes

Intervention Type: DEVICE

Fetoscopes are telescopes developed for procedures involving fetal interventions and is inserted through the maternal abdomen.

Fetal Cystoscopy

Intervention Type: PROCEDURE

A fetoscope will be inserted into the fetal bladder via the maternal abdomen and advanced into the fetal bladder outlet. Identified obstruction will be opened using laser.

Interventions

Fetoscopes

Fetoscopes are telescopes developed for procedures involving fetal interventions and is inserted through the maternal abdomen.

Intervention Type: DEVICE

Fetal Cystoscopy

A fetoscope will be inserted into the fetal bladder via the maternal abdomen and advanced into the fetal bladder outlet. Identified obstruction will be opened using laser.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Pregnant women

2. Singleton pregnancy

3. Maternal age ≥ 18 years

4. Male fetus with LUTO, dilated bladder, "keyhole sign" and bilateral hydronephrosis

5. Oligohydramnios or Anhydramnios

6. Favorable urine analysis defined as urinary sodium is < 100 milliequivalents per liter (mEq/L), chloride < 90 mEq/L, and osmolality < 200 milliosmoles per kilogram (mOsm/kg) after 20 weeks and in the absence of previous in utero intervention for the disease (vesicoamniotic shunt placement or fetal cystoscopy).

7. Absence of chromosomal abnormalities and associated anomalies

8. Gestational age at the time of the procedure will be between 16 0/7 weeks and 25 6/7 weeks

9. Normal karyotype by invasive testing (amniocentesis or Chorionic Villus Sampling (CVS)). Patients declining invasive testing will be excluded.

10. Family have considered and declined the option of termination of the pregnancy at less than 24 weeks.

11. Family meets psychosocial criteria, including sufficient social support and ability to understand requirements of the study.

12. Parents or guardian are willing to provide signed informed consent.

Exclusion Criteria

1. Fetal anomaly unrelated to LUTO

2. Congenital cardiac anomaly

3. Female fetus

4. Increased risk for preterm labor including short cervical length (<1.5 cm), history of incompetent cervix with or without cerclage, and previous preterm birth

5. Placental abnormalities (previa, abruption, accreta) known at time of enrollment

6. Contraindications to surgery including previous hysterotomy in active uterine segment

7. Technical limitations precluding fetoscopic surgery, such as uterine fibroids, fetal membrane separation, uterine anomalies incompatible with fetoscopy

8. Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy

9. Maternal HIV, Hepatitis-B, Hepatitis-C status positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patient's HIV or Hepatitis status is unknown, the patient must be tested and found to have negative results before enrollment

10. Maternal medical condition that is a contraindication to surgery or anesthesia

11. Patient does not have health insurance to cover routine clinical care including prenatal care, prenatal ultrasound, amniocentesis, tocolysis, admission, delivery, and fetal vesico-amniotic shunting. The exception will be fetal cystoscopy which is considered an experimental procedure.

12. Inability to comply with travel and follow-up requirements of the trial

13. Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy

14. Patients declining invasive testing

15. Family does not meet psychosocial criteria including insufficient

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Rodrigo Ruano

OTHER

Sponsor Role: lead

Responsible Party

Rodrigo Ruano

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Rodrigo Ruano, MD, PhD.

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami

Miami, Florida, United States

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

16-008556

Identifier Type: OTHER

Identifier Source: secondary_id

20220117-1

Identifier Type: -

Identifier Source: org_study_id

NCT05368727

Identifier Type: -

Identifier Source: nct_alias