Fetal Cystoscopy for Severe Lower Urinary Tract Obstruction (LUTO)
| Status: | Recruiting |
|---|---|
| Conditions: | Nephrology |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/5/2018 |
| Start Date: | January 1, 2018 |
| End Date: | July 31, 2021 |
| Contact: | Maureen A. Lemens, BSN, RN |
| Email: | lemens.maureen@mayo.edu |
| Phone: | 507-293-1487 |
Fetal Cystoscopy for Severe Lower Urinary Tract Obstruction (LUTO): A Prospective Trial
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.
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.
Inclusion Criteria:
- Pregnant females age ≥ 18 years
- Oligohydramnios or Anhydramnios
- Singleton male fetus with LUTO, dilated bladder, "keyhole sign" and bilateral
hydronephrosis
- Urine analysis: urinary sodium < 100 milliequivalents per liter (mEq/L), chloride < 90
mEq/L, osmolarity <200 milliosmoles/liter (mOsm/L) and β2-microglobulin <6mg/L
- Absence of chromosomal abnormalities and associated anomalies
- Gestational age at the time of the procedure between 16 0/7 weeks and 25 6/7 weeks
- Normal karyotype by invasive testing (amniocentesis or CVS).
- Family have considered and declined the option of termination of the pregnancy at less
than 24 weeks.
- Family has sufficient social support and ability to understand requirements of the
study.
- Parents or guardians are willing to provide signed informed consent.
Exclusion Criteria:
- Fetal anomaly or congenital cardiac anomaly unrelated to LUTO
- Female fetus
- Increased risk for preterm labor, cervical length (<1.5 cm), previous preterm birth,
history of incompetent cervix with or without cerclage
- 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 positive (testing must be done and be negative)
- Maternal medical condition that is a contraindication to surgery or anesthesia
- Patient does not have health insurance to cover routine prenatal clinical care,
including prenatal ultrasound, amniocentesis, tocolysis, admission, delivery, and
fetal vesico-amniotic shunting
- 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
- Unable to understand the study procedures or unable to provide voluntary informed
consent
We found this trial at
1
site
200 First Street SW
Rochester, Minnesota 55905
Rochester, Minnesota 55905
507-284-2511
Phone: 507-284-0210
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