An interventional study of Fetoscopes and Fetal Cystoscopy in Lower Urinary Tract Obstructive Syndrome, Lower Urinary Tract Obstruction, Congenital and Bladder Outlet Obstruction, sponsored by Rodrigo Ruano. Recruiting at 2 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-24.
Sponsored by Rodrigo Ruano · Not applicable, Interventional, and Treatment
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).
Exclusion Criteria:
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 · Procedure: Fetal Cystoscopy
Fetoscopes are telescopes developed for procedures involving fetal interventions and is inserted through the maternal abdomen.
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.
Number of participants where the procedure was technically performed
Number of participants where the fetal cystoscopy procedure was successfully technically performed.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 1 post delivery
Plan to share: No
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