Actively Recruiting
Fetal Cystoscopy for Severe Lower Urinary Tract Obstruction (LUTO): A Prospective Trial
Led by Rodrigo Ruano · Updated on 2026-02-24
10
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating outcomes for pregnant women and their babies who have severe isolated lower urinary tract obstruction (LUTO) affecting the fetus. The study focuses on patients undergoing fetal intervention to better understand the effects on both maternal and fetal health. This prospective trial aims to assess whether fetal cystoscopy can help diagnose and treat this condition during pregnancy. Participants will receive a fetal cystoscopy procedure between 16 weeks 0 days and 25 weeks 6 days of gestation. This involves inserting a fetoscope, a special telescope, through the mother's abdomen into the fetal bladder to identify and open any obstruction using a laser. The study tracks technical success of the procedure, diagnosis accuracy, and outcomes such as release of the obstruction and prevention of severe lung and kidney problems after birth. During the study, researchers will monitor participants closely with follow-up evaluations up to 24 months after delivery. They will collect data on the procedure's technical performance, diagnosis correctness, and any maternal complications. The study measures the success of preventing severe pulmonary hypoplasia and renal impairment in the newborn. Participants will provide informed consent and will be supported throughout the trial duration.
CONDITIONS
Brief Title
Fetal Cystoscopy for Severe Lower Urinary Tract Obstruction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant women
- Singleton pregnancy
- Maternal age 18 years or older
- Male fetus with LUTO, dilated bladder, "keyhole sign" and bilateral hydronephrosis
- Oligohydramnios or anhydramnios
- Favorable urine analysis after 20 weeks with urinary sodium < 100 mEq/L, chloride < 90 mEq/L, and osmolality < 200 mOsm/kg
- No previous in utero intervention for LUTO
- No chromosomal abnormalities or associated anomalies
- Gestational age between 16 weeks 0 days and 25 weeks 6 days at procedure
- Normal karyotype confirmed by invasive testing
- Family considered and declined termination of pregnancy before 24 weeks
- Family meets psychosocial criteria including sufficient social support
- Parents or guardian willing to provide signed informed consent
You will not qualify if you...
- Fetal anomaly unrelated to LUTO
- Congenital cardiac anomaly
- Female fetus
- Increased risk for preterm labor (e.g., short cervical length <1.5 cm, history of incompetent cervix, previous preterm birth)
- Known placental abnormalities (previa, abruption, accreta)
- Contraindications to surgery such as previous hysterotomy in active uterine segment
- Technical limitations preventing fetoscopic surgery (e.g., uterine fibroids, fetal membrane separation, uterine anomalies)
- Maternal-fetal Rh isoimmunization, Kell sensitization, or neonatal alloimmune thrombocytopenia
- Maternal HIV, Hepatitis-B, or Hepatitis-C positive status
- Maternal medical condition contraindicating surgery or anesthesia
- Lack of health insurance for routine prenatal care (except fetal cystoscopy)
- Inability to comply with travel and follow-up requirements
- Participation in another intervention study affecting maternal or fetal outcomes
- Declining invasive genetic testing
- Family does not meet psychosocial criteria including insufficient support
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 9 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Procedure performed between 16 weeks 0 days and 25 weeks 6 days of gestation
Participants receive a fetal cystoscopy procedure involving insertion of a fetoscope through the maternal abdomen to the fetal bladder to open the obstruction using laser.
1 procedure visit (in-person)
Duration - Up to 24 months post delivery
Participants are monitored after the procedure to assess outcomes including diagnosis accuracy, release of obstruction, and prevention of post-natal complications.
Multiple follow-up visits up to 24 months after delivery
Trial Site Locations
Total: 2 locations
1
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
2
Mayo Clinic
Rochester, Minnesota, United States, 55905
Terminated
Research Team
R
Rodrigo A Ruano, MD, PhD.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here