Lower Urinary Tract Obstructive Syndrome
Conditions
Keywords
LUTO, posterior urethral valves, urethral atresia
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.
Interventions
PROCEDURECYSTO
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.
PROCEDUREVesico-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.
Sponsors
University of Sao Paulo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* presence of other anomalies diagnosed after fetal intervention * maternal refusal to participate in the present protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 1 year of age | 1 year of age | The survival rate will be evaluated at 1 year of age. |
| 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. |
Countries
Brazil
Contacts
Primary ContactEugenia MA Salustiano, RN
Backup ContactRodrigo Ruano, MD, PhD
Outcome results
None listed