Fetal Cystoscopy Versus Vesico-amniotic Shunting in Severe Lower Urinary Tract Obstructions (CYSTUO)
Lower Urinary Tract Obstructive Syndrome
Procedure: Vesico-amniotic shunt
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Randomized Controlled Trial of Fetal Cystoscopy Versus Vesico-amniotic Shunting in Severe Lower Urinary Tract Obstructions|
- Perinatal survival rate [ Time Frame: from fetal period to neonatal perid (up to 28 days after birth) ] [ Designated as safety issue: Yes ]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 [ Time Frame: up to 28 days of life ] [ Designated as safety issue: No ]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.
- Survival rate at 6 months [ Time Frame: Up to 6 months of life ] [ Designated as safety issue: No ]The survival rate up to 6 months of life will be evaluated.
- Renal function at 6 months of life [ Time Frame: 6 months of life ] [ Designated as safety issue: No ]Renal function will be evaluated by serum creatinine, need for dialysis and/or renal transplantation.
- Survival rate at 1 year of age [ Time Frame: 1 year of age ] [ Designated as safety issue: No ]The survival rate will be evaluated at 1 year of age.
- Renal function at 1 year of age [ Time Frame: 1 year of age ] [ Designated as safety issue: No ]Renal function will be evaluated by serum creatinine, need for dialysis and/or renal transplantation.
|Study Start Date:||June 2015|
|Estimated Study Completion Date:||June 2018|
|Estimated Primary Completion Date:||May 2017 (Final data collection date for primary outcome measure)|
Experimental: Vesico-amniotic shunt
In this arm, patients will be randomly selected to undergo vesico-amniotic shunting.
Procedure: Vesico-amniotic shunt
In this arm, all patients randomly selected for this treatment will undergo vesico-amniotic shunting under ultrasound guidance. Maternal anesthesia will be conducted by epidural anesthesia and fetal anesthesia will be conducted by injecting fentanyl (15 μg/Kg) and pancuronium (2 mg/Kg) under ultrasound guidance of a 22 gauge needle into fetal arm muscle.
In this arm, all patients will be randomly selected for fetal cystoscopy.
Fetal cystoscopy will be performed by introducing a 2.2mm sheath with 1.0mm fetoscope into fetal bladder under ultrasound guidance. The fetoscope will be advanced and the posterior urethral valves will be coagulated by ND:YAG laser. If urethra atresia was diagnosed, a vesico-amniotic shunting will be placed. Maternal anesthesia will be conducted by epidural anesthesia and fetal anesthesia will be conducted by injecting fentanyl (15 μg/Kg) and pancuronium (2 mg/Kg) under ultrasound guidance of a 22 gauge needle into fetal arm muscle.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01552824
|Contact: Eugenia MA Salustiano, RN||(5511)firstname.lastname@example.org|
|Contact: Rodrigo Ruano, MD, PhD||(5511)email@example.com|
|Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo||Active, not recruiting|
|Sao Paulo, Brazil, 05403-010|
|Principal Investigator:||Rodrigo Ruano, MD, PhD||Faculdade de Medicina da Universidade de Sao Paulo|