Fetal Cystoscopy for Severe Lower Urinary Tract Obstruction

NCT03281798 | Recruiting DMC FDA Device

• 2 other identifiers: 20220117-116-008556
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (6)

• Number of participants where the procedure was technically performed

  Number of participants where the fetal cystoscopy procedure was successfully technically performed.

  Day 1 (Post fetal cystoscopy procedure)

• Number of participants where the etiology of LUTO was correctly diagnosed

  Number of participants where the etiology of LUTO was correctly diagnosed during fetal cystoscopy as compared to post natal cystoscopy

  Up to 1 month post delivery

• Number of participants where the posterior urethral valve were successfully released

  Number of participants where the posterior urethral valve were successfully released

  Day 1 (Post fetal cystoscopy procedure)

• Number of participants whose fetal cystoscopy resulted in the prevention of post-natal severe pulmonary hypoplasia

  As per treating physician evaluation of clinical assessments post-natal.

  Up to 1 month post delivery

• Number of participants whose fetal cystoscopy resulted in the prevention of post-natal severe renal impairment

  As per treating physician evaluation of clinical assessments post-natal.

  Up to 24 months post delivery

• Number of participants whose fetal cystoscopy resulted in maternal complications

  Maternal and obstetrical complications such as preterm premature rupture of the membranes (PPROM), prematurity (birth \<37 weeks), extremely preterm birth (\<32 weeks), and urological fistulae and fetal demise.

  Day 1 post delivery

Study Arms (1)

Fetal Cystoscopy Group

EXPERIMENTAL

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

Device: Fetoscopes; Procedure: Fetal Cystoscopy

Interventions

Fetoscopes DEVICE

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

Fetal Cystoscopy Group

Fetal Cystoscopy 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.

Fetal Cystoscopy Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women
• Singleton pregnancy
• Maternal age ≥ 18 years
• Male fetus with LUTO, dilated bladder, "keyhole sign" and bilateral hydronephrosis
• Oligohydramnios or Anhydramnios
• 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).
• Absence of chromosomal abnormalities and associated anomalies
• Gestational age at the time of the procedure will be between 16 0/7 weeks and 25 6/7 weeks
• Normal karyotype by invasive testing (amniocentesis or Chorionic Villus Sampling (CVS)). Patients declining invasive testing will be excluded.
• Family have considered and declined the option of termination of the pregnancy at less than 24 weeks.
• Family meets psychosocial criteria, including sufficient social support and ability to understand requirements of the study.
• Parents or guardian are willing to provide signed informed consent.

You may not qualify if:

• Fetal anomaly unrelated to LUTO
• Congenital cardiac anomaly
• Female fetus
• Increased risk for preterm labor including short cervical length (\<1.5 cm), history of incompetent cervix with or without cerclage, and previous preterm birth
• Placental abnormalities (previa, abruption, accreta) known at time of enrollment
• Contraindications to surgery including previous hysterotomy in active uterine segment
• Technical limitations precluding fetoscopic surgery, such as uterine fibroids, fetal membrane separation, uterine anomalies incompatible with fetoscopy
• Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy
• 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
• Maternal medical condition that is a contraindication to surgery or anesthesia
• 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.
• Inability to comply with travel and follow-up requirements of the trial
• Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy
• Patients declining invasive testing
• Family does not meet psychosocial criteria including insufficient

Sponsors & Collaborators

• Rodrigo Ruano: lead

Study Sites (2)

University of Miami

Miami, Florida, 33136, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

TERMINATED

MeSH Terms

Conditions

Urinary Bladder Neck Obstruction

Interventions

Fetoscopes

Condition Hierarchy (Ancestors)

Urethral Obstruction; Urethral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Endoscopes; Diagnostic Equipment; Equipment and Supplies; Surgical Equipment

Study Officials

• Rodrigo Ruano, MD, PhD.

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rodrigo A Ruano, MD, PhD.

CONTACT

305.243.0769; rodrigo.ruano@miami.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 11, 2017
• First Posted: September 13, 2017
• Study Start: January 1, 2018
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)