Fetal Cystoscopy Versus Vesico-amniotic Shunting in Severe Lower Urinary Tract Obstructions

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Controlled Trial of Fetal Cystoscopy Versus Vesico-amniotic Shunting in Severe Lower Urinary Tract Obstructions

Conditions
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Lower Urinary Tract Obstructive Syndrome

Intervention / Treatment
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* Procedure: CYSTO
* Procedure: Vesico-amniotic shunt


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vesico-amniotic shunt<br>In this arm, patients will be randomly selected to undergo vesico-amniotic shunting. | Procedure: Vesico-amniotic shunt<br>* 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.<br>|
| Experimental: CYSTO<br>In this arm, all patients will be randomly selected for fetal cystoscopy. | Procedure: CYSTO<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perinatal survival rate | 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. | from fetal period to neonatal perid (up to 28 days after birth) | 
| Neonatal renal function | 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. | up to 28 days of life | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate at 6 months | The survival rate up to 6 months of life will be evaluated. | Up to 6 months of life | 
| Renal function at 6 months of life | Renal function will be evaluated by serum creatinine, need for dialysis and/or renal transplantation. | 6 months of life | 
| Survival rate at 1 year of age | The survival rate will be evaluated at 1 year of age. | 1 year of age | 
| Renal function at 1 year of age | Renal function will be evaluated by serum creatinine, need for dialysis and/or renal transplantation. | 1 year of age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LUTO, posterior urethral valves, urethral atresia