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).
Pregnant women
Singleton pregnancy
Maternal age ≥ 18 years
Male fetus with LUTO, dilated bladder, "keyhole sign" and bilateral hydronephrosis
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
Single group
Fetoscopes
DeviceFetoscopes are telescopes developed for procedures involving fetal interventions and is inserted through the maternal abdomen.
Fetal Cystoscopy
Procedure/SurgeryA 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.
Number of participants where the procedure was technically performed
Number of participants where the fetal cystoscopy procedure was successfully technically performed.
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
Number of participants where the posterior urethral valve were successfully released
Number of participants where the posterior urethral valve were successfully released
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.
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Rodrigo Ruano
Lead sponsor
University of Miami
Sponsor institution
