Fetal Cystoscopy for Severe Lower Urinary Tract Obstruction (LUTO)
Tab Title Description
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Rochester, Minnesota: 16-008556
NCT ID: NCT03281798
Sponsor Protocol Number: 16-008556
About this study
This is a pilot study to evaluate the safety, feasibility and effectiveness of fetal cystoscopy in the prenatal diagnosis and therapy of fetuses with bladder outlet obstruction. Fetal bladder outlet obstruction is a rare congenital anomaly with severe consequences to the fetus. Because of the bladder outlet obstruction, amniotic fluid is diminished, drastically leading to abnormal development of the fetal lungs. In addition, the obstruction leads to significant kidney damage, including development of end stage renal disease. Fetal vesicoamniotic shunting is the clinical therapeutic option for these fetuses. However, the shunt has many complications including blockage and dislodgement. Fetal cystoscopy has been proposed as an alternative treatment with potential advantages over the shunt by allowing the correct prenatal diagnosis and specific treatment. Initial clinical trials have demonstrated favorable outcomes. 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) at Mayo Clinic in Rochester, Minnesota. The objectives are to evaluate the safety, feasibility, and effectiveness of fetal cystoscopy as an experimental procedure in avoiding perinatal death and renal impairment and to compare to our clinical experience with fetal vesico-amniotic shunting.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
- Pregnant women.
- Singleton pregnancy.
- Maternal age ≥ 18 years old.
- Male fetus with LUTO, dilated bladder, "keyhole sign" and bilateral hydronephrosis.
- Oligohydramnios or Anhydramnios.
- Favorable urine analysis defined as urinary sodium is < 100mEq/L, chloride < 90mEq/L, and osmolarity < 200mOsm/L .
- 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 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.
- 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 social support and inability to understand requirements of the study.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
|Mayo Clinic Location
Mayo Clinic principal investigator
Patricio Gargollo, M.D.
Closed for enrollment
Publications are currently not available