Vesicoureteral Reflux
Conditions
Brief summary
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.
Interventions
PROCEDUREAnti-reflux surgery
Open ureteroneocystostomy for correction of vesicoureteral reflux
PROCEDUREEndoscopic injection
Endoscopic injection of dextranomer/hyaluronic acid gel (Deflux) for correction of vesicoureteral reflux
Sponsors
Boston Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 11 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Resolution of VUR at 4 months | 4 months |
Countries
United States
Outcome results
None listed