Clinical trial NCT01552824: Fetal Cystoscopy Versus Vesico-amniotic Shunting in Severe Lower Urinary Tract Obstructions
Official title: Randomized Controlled Trial of Fetal Cystoscopy Versus Vesico-amniotic Shunting in Severe Lower Urinary Tract Obstructions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Lower Urinary Tract Obstructive Syndrome
Keywords: LUTO
posterior urethral valves
urethral atresia
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2012-03-13
Enrollment: 60
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Perinatal survival rate
timeFrame: from fetal period to neonatal perid (up to 28 days after birth)
measure: Neonatal renal function
timeFrame: up to 28 days of life
Secondary outcomes:
measure: Survival rate at 6 months
timeFrame: Up to 6 months of life
measure: Renal function at 6 months of life
timeFrame: 6 months of life
measure: Survival rate at 1 year of age
timeFrame: 1 year of age
measure: Renal function at 1 year of age
timeFrame: 1 year of age
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
Study officials:
affiliation: Faculdade de Medicina da Universidade de Sao Paulo
name: Rodrigo Ruano, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ruano R, Pimenta EJ, Duarte S, Zugaib M. Four-dimensional ultrasonographic imaging of fetal lower urinary tract obstruction and guidance of percutaneous cystoscopy. Ultrasound Obstet Gynecol. 2009 Feb;33(2):250-2. doi: 10.1002/uog.6292. No abstract available.
citation: Ruano R, Duarte S, Bunduki V, Giron AM, Srougi M, Zugaib M. Fetal cystoscopy for severe lower urinary tract obstruction--initial experience of a single center. Prenat Diagn. 2010 Jan;30(1):30-9. doi: 10.1002/pd.2418.
citation: Ruano R, Yoshisaki CT, Salustiano EM, Giron AM, Srougi M, Zugaib M. Early fetal cystoscopy for first-trimester severe megacystis. Ultrasound Obstet Gynecol. 2011 Jun;37(6):696-701. doi: 10.1002/uog.8963.
citation: Morris RK, Ruano R, Kilby MD. Effectiveness of fetal cystoscopy as a diagnostic and therapeutic intervention for lower urinary tract obstruction: a systematic review. Ultrasound Obstet Gynecol. 2011 Jun;37(6):629-37. doi: 10.1002/uog.8981. Epub 2011 May 16.
citation: Ruano R. Fetal surgery for severe lower urinary tract obstruction. Prenat Diagn. 2011 Jul;31(7):667-74. doi: 10.1002/pd.2736. Epub 2011 Mar 17.