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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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 Summary:

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.


Sponsor: University of Sao Paulo General Hospital

Current Primary Outcome:

  • Perinatal survival rate [ Time Frame: 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 [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Survival rate at 6 months [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 1 year of age ]
    The survival rate will be evaluated at 1 year of age.
  • Renal function at 1 year of age [ Time Frame: 1 year of age ]
    Renal function will be evaluated by serum creatinine, need for dialysis and/or renal transplantation.


Original Secondary Outcome:

  • Survival rate at 6 months [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 1 year of age ]
    The survival rate will be evaluated at 1 year of age.
  • Renal fucntion at 1 year of age [ Time Frame: 1 year of age ]
    Renal function will be evaluated by serum creatinine, need for dialysis and/or renal transplantation.


Information By: University of Sao Paulo General Hospital

Dates:
Date Received: March 9, 2012
Date Started: June 2015
Date Completion: June 2018
Last Updated: May 9, 2015
Last Verified: May 2015