Fetal Cystoscopy for Severe Lower Urinary Tract Obstruction (LUTO): A Prospective Trial
Rodrigo Ruano
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).
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
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. Gest…
Interventions
- DeviceFetoscopes
Fetoscopes are telescopes developed for procedures involving fetal interventions and is inserted through the maternal abdomen.
- ProcedureFetal 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 (2)
- University of MiamiMiami, Florida
- Mayo ClinicRochester, Minnesota