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

NCT01552824 | Unknown Phase 2 DMC

• 1 other identifier: 0853/11
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Urinary Tract Obstructive Syndrome

Keywords

LUTO; posterior urethral valves; urethral atresia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Survival rate at 6 months

  Up to 6 months of life

• Renal function at 6 months of life

  6 months of life

• Survival rate at 1 year of age

  1 year of age

• Renal function at 1 year of age

  1 year of age

Study Arms (2)

Vesico-amniotic shunt

EXPERIMENTAL

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

Procedure: Vesico-amniotic shunt

CYSTO

EXPERIMENTAL

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

Procedure: CYSTO

Interventions

CYSTO PROCEDURE

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.

CYSTO

Vesico-amniotic shunt PROCEDURE

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.

Vesico-amniotic shunt

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• presence of other anomalies diagnosed after fetal intervention
• maternal refusal to participate in the present protocol

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

São Paulo, São Paulo, 05403-010, Brazil

Location

Related Publications (5)

• 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.

  PMID: 19173237 BACKGROUND

• 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.

  PMID: 19967749 BACKGROUND

• 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.

  PMID: 21337440 BACKGROUND

• 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.

  PMID: 21374748 BACKGROUND

• 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.

  PMID: 21413041 BACKGROUND

Study Officials

• Rodrigo Ruano, MD, PhD

  Faculdade de Medicina da Universidade de Sao Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eugenia MA Salustiano, RN

CONTACT

(5511)2661-6209; eugeniaassuncao@hotmail.com

Rodrigo Ruano, MD, PhD

CONTACT

(5511)2661-6209; rodrigoruano@usp.br

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: March 9, 2012
• First Posted: March 13, 2012
• Study Start: June 1, 2015
• Primary Completion: May 1, 2017
• Study Completion: June 1, 2018
• Last Updated: May 12, 2015

Record last verified: 2015-05

Locations

BR (1)