Lower Urinary Tract Obstructive Syndrome Clinical Trial
Official title:
Randomized Controlled Trial of Fetal Cystoscopy Versus Vesico-amniotic Shunting in Severe Lower Urinary Tract Obstructions
There are two options of fetal treatment in cases of severe lower urinary tract obstructions: the vesico-amniotic shunting and fetal cystoscopy. There is no study confirming the effectiveness of these treatment, specially comparing both techniques. The present study aims to investigate the effectiveness of these treatments.
Objectives: To evaluate the effectiveness of fetal cystoscopy for the diagnosis and therapy
of the posterior urethral valves and to compare with the results of vesicoamniotic shunting.
Outcomes: Accuracy of the prenatal cystoscopic diagnosis of posterior urethral valves,
neonatal and infant survival (6 and 12 months), as well as normal renal function during the
same ages.
Study design: Randomized controlled trial. Methods: Pregnant women whose fetuses have
isolated and severe lower urinary tract obstruction (LUTO) with (oligohydramnios and severe
hydronephrosis) will be invited to participate in the present study. Patients will be
randomized into the fetal cystoscopic group (CYSTO) vs vesico-amniotic shunting (VAS). The
investigators intend to enroll 30 patients in each group (a total of 60). All patients will
be followed by fetal ultrasound each 15 days. Besides, these infants will be followed up to
one year of age. Maternal and obstetrical complications are going to be evaluated as well as
neonatal and infant survival and the renal function.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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