Study of Endoscopic Versus Open Surgery for Urinary Reflux

Boston Children's Hospital

Overview

This study seeks to compare outcomes after anti-reflux surgery (ARS) for correction of low-grade vesicoureteral reflux (VUR). It is a randomized controlled open-label trial of conventional open anti-reflux technique versus endoscopic anti-reflux technique with injection of dextranomer/hyaluronic acid copolymer (Deflux). Primary endpoint will be resolution of VUR at initial cystogram after ARS. Secondary outcomes will include incidence of postoperative UTI, resolution of VUR at 1-year cystogram after ARS, surgical complications, and quality of life measures after ARS.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Vesicoureteral Reflux

Interventions

Anti-reflux surgeryPROCEDURE

Open ureteroneocystostomy for correction of vesicoureteral reflux

Endoscopic injectionPROCEDURE

Endoscopic injection of dextranomer/hyaluronic acid gel (Deflux) for correction of vesicoureteral reflux

Eligibility

Sex: ALLMax age: 11 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age \<12 years * Unilateral or Bilateral Primary VUR * Grade 2 or 3 (VCUG) or Grade 2 (RNC) VUR in at least 1 ureter * Recommended for surgical correction of VUR by Urologist Exclusion Criteria: * Grade 4 or 5 (VCUG) or Grade 3 (RNC) VUR * Secondary VUR (neurogenic bladder, exstrophy, or other causes of secondary VUR) * Ureterocele * Periureteral diverticulum * Complete duplication of duplex collecting system on side with VUR * Prior ARS, either open or endoscopic, regardless of success or failure * History of other prior urinary tract surgery other than circumcision * Solitary functional kidney * Congenital or acquired immunodeficiency * Chronic renal insufficiency or renal failure

Locations (1)

Children's Hospital Boston

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Resolution of VUR at 4 months

Time frame: 4 months

Data from ClinicalTrials.gov

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