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(for at least one location)
Describes the nature of a clinical study. Types include:
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.
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