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

University of Sao Paulo General Hospital

Status and phase: Unknown; Phase 2

Conditions: Lower Urinary Tract Obstructive Syndrome

Treatments: Procedure: Vesico-amniotic shunt; Procedure: CYSTO

Study type: Interventional

Funder types: Other

Identifiers

NCT01552824

0853/11 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Male

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Vesico-amniotic shunt

Experimental group

Description:

In this arm, patients will be randomly selected to undergo vesico-amniotic shunting.

Treatment:

Procedure: Vesico-amniotic shunt

CYSTO

Experimental group

Description:

In this arm, all patients will be randomly selected for fetal cystoscopy.

Treatment:

Procedure: CYSTO