Fetal Cystoscopy for Severe Lower Urinary Tract Obstruction

Study Overview
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Brief Summary
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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).

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

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

Intervention / Treatment
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* Device: Fetoscopes
* Procedure: Fetal Cystoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fetal Cystoscopy Group<br>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<br>* Fetoscopes are telescopes developed for procedures involving fetal interventions and is inserted through the maternal abdomen.<br>Procedure: Fetal Cystoscopy<br>* 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.<br>|

What is the study measuring?
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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 |