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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2013 by University of Sao Paulo General Hospital
Sponsor:
Information provided by (Responsible Party):
Rodrigo Ruano, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01552824
First received: March 9, 2012
Last updated: December 14, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Lower Urinary Tract Obstructive Syndrome
Procedure: CYSTO
Procedure: Vesico-amniotic shunt
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 60
Study Start Date: June 2014
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Experimental: CYSTO
In this arm, all patients will be randomly selected for fetal cystoscopy.
Procedure: CYSTO
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.

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

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01552824

Contacts
Contact: Eugenia MA Salustiano, RN (5511)2661-6209 eugeniaassuncao@hotmail.com
Contact: Rodrigo Ruano, MD, PhD (5511)2661-6209 rodrigoruano@usp.br

Locations
Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo Active, not recruiting
Sao Paulo, Brazil, 05403-010
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
Principal Investigator: Rodrigo Ruano, MD, PhD Faculdade de Medicina da Universidade de Sao Paulo
  More Information

Publications:
Responsible Party: Rodrigo Ruano, PhD, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT01552824     History of Changes
Other Study ID Numbers: 0853/11, 0853/11
Study First Received: March 9, 2012
Last Updated: December 14, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo General Hospital:
LUTO
posterior urethral valves
urethral atresia

ClinicalTrials.gov processed this record on October 20, 2014