Fetal Cystoscopy Versus Vesico-amniotic Shunting in Severe Lower Urinary Tract Obstructions
- Conditions
- Lower Urinary Tract Obstructive Syndrome
- Interventions
- Procedure: Vesico-amniotic shuntProcedure: CYSTO
- Registration Number
- NCT01552824
- Lead Sponsor
- University of Sao Paulo General Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 60
- single pregnancy
- male fetuses
- gestational age dating by ultrasound examination performed before 20 weeks
- confirmed severe LUTO (see details before)
- severe oligohydramnios (AFI<5.0cm)
- no other structural anomalies by complete fetal anatomy ultrasound scan and fetal echocardiogram
- no abnormal karyotype
- 'favorable' urine analysis (urinary sodium <100 mEq/L, chloride <90 mEq/L, osmolarity <200 mOsm/L) when gestational age >20 weeks
- presence of other anomalies diagnosed after fetal intervention
- maternal refusal to participate in the present protocol
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vesico-amniotic shunt Vesico-amniotic shunt In this arm, patients will be randomly selected to undergo vesico-amniotic shunting. CYSTO CYSTO In this arm, all patients will be randomly selected for fetal cystoscopy.
- Primary Outcome Measures
Name Time Method Perinatal survival rate from fetal period to neonatal perid (up to 28 days after birth) The primary outcome is survival from the treatment to the neonatal period (up to 28 days of life). Therefore, the objective is to evaluate the safety and effectiveness of both therapeutic options.
Neonatal renal function up to 28 days of life Renal function will be evaluated by serum creatine and urinalysis in the neonates, as well as by micturating cystourethrography and postnatal cystoscopy after birth up to 28 days of life.
- Secondary Outcome Measures
Name Time Method Survival rate at 1 year of age 1 year of age The survival rate will be evaluated at 1 year of age.
Renal function at 6 months of life 6 months of life Renal function will be evaluated by serum creatinine, need for dialysis and/or renal transplantation.
Survival rate at 6 months Up to 6 months of life The survival rate up to 6 months of life will be evaluated.
Renal function at 1 year of age 1 year of age Renal function will be evaluated by serum creatinine, need for dialysis and/or renal transplantation.
Trial Locations
- Locations (1)
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
🇧🇷Sao Paulo, Brazil