Fetal Cystoscopy for Severe Lower Urinary Tract Obstruction

Bladder Outlet Obstruction Clinical Trial

— CYSTO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03281798
• Other study ID #: 20220117-1
• Secondary ID: 16-008556
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: August 1, 2027

Study information

• Verified date: April 2024
• Source: University of Miami
• Contact: Rodrigo A Ruano, MD, PhD.
• Phone: 305.243.0769
• Email: rodrigo.ruano[@]miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Other known NCT identifiers

• NCT05368727

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: August 1, 2027
• Est. primary completion date: August 1, 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Outlet Obstruction
• Lower Urinary Tract Obstructive Syndrome
• Urinary Bladder Neck Obstruction

Intervention

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.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Rodrigo Ruano

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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)
Primary	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
Primary	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
Primary	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