Fetal Cystoscopy for Severe Lower Urinary Tract Obstruction (CYSTO)

Fetal Cystoscopy for Severe Lower Urinary Tract Obstruction (LUTO): A Prospective Trial

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).

Study Overview

• Status: Recruiting
• Conditions: Bladder Outlet Obstruction; Lower Urinary Tract Obstructive Syndrome; Lower Urinary Tract Obstruction, Congenital; Bladder Outflow Obstruction
• Intervention / Treatment: Device: Fetoscopes; Procedure: Fetal Cystoscopy

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rodrigo A Ruano, MD, PhD.; Phone Number: 305.243.0769; Email: rodrigo.ruano@miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami
      • Contact: Rodrigo Ruano, MD, Ph.D; Phone Number: 305-243-0769; Email: rodrigo.ruano@miami.edu
      • Principal Investigator: Rodrigo Ruano
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Terminated
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Fetoscopes; Fetoscopes are telescopes developed for procedures involving fetal interventions and is inserted through the maternal abdomen.; Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Rodrigo Ruano
• Investigators: Principal Investigator: Rodrigo Ruano, MD, PhD., University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: September 11, 2017
• First Submitted That Met QC Criteria: September 11, 2017
• First Posted (Actual): September 13, 2017

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Urethral Diseases; Urethral Obstruction; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder Neck Obstruction
• Other Study ID Numbers: 20220117-1; 16-008556 (Other Identifier: Mayo Clinic)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes