A Prospective Study Comparing the Success Rate of Injection of (DefluxR) Versus (VantrisR) for VUR in Children

NCT02271035 | Unknown Phase 4

• 1 other identifier: Rabin Medical Center
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Vesicoureteral reflux (VUR) is the most common urologic diagnosis in neonates estimated at 1% of newborns, and 30-45% of the children who present with urinary tract infection (1). Optional treatments of children with VUR include conservative therapy with or without prophylactic antibiotics, and endoscopic, laparoscopic, or open surgery. In an endoscopic technique, the injecting needle is inserted through the working channel of the cystoscope. The procedure is relatively short and is performed as out-patient surgery. In 2000, Dextranomer/Hyaluronic acid (DefluxR) was approved by the FDA, and subsequently has become the treatment of choice in VUR grades 2-4. In 2004, the hydrodistention-implantation technique (HIT) was introduced by Kirsch. HIT involves the use of a pressurized stream of fluid directed into the ureter to aid visualization, and injection into the submucosa within the ureteric tunnel to improve coaptation of the ureter (3). One of the disadvantages attributed to Deflux is the loss of 20% of the injected material over time (a result of absorption of the hyaluronic acid), which may explain the lower success rate of the endoscopic treatment of VUR compared with open surgery. In 2005, Polyacrylate Polyalcohol (VantrisR), a non- absorbable chemical preparation was introduced for endoscopic treatment of VUR, aiming to improve on the results of Deflux by preventing volume loss. Preliminary results of a three year follow-up using Vantris have shown high a level of reflux resolution(4). The aim of the current study is to compare the rate of resolution of the VUR using Deflux versus Vantris in bilateral VUR

Conditions

Vesico-Ureteral Reflux

Keywords

VUR

Outcome Measures

Primary Outcomes (1)

• rate of resolution of VUR using Vantris vs.Deflux

  2 years

Study Arms (2)

Deflux

ACTIVE COMPARATOR

In each patient, Deflux will be injected into one of the ureteral orifices using the the HIT technique.

Drug: Deflux

Vantris

ACTIVE COMPARATOR

Vantris will be injected into the other ureteral orifice using the same technique and the same amount of implant.

Drug: Vantris

Interventions

Deflux DRUG

Deflux will be injected through the working channel of the cystoscope using a special needle into the submucosal space of the ureteral orifice (Deflux to one ureteral orifice and Vantris to the other side). The technique that will be used is HIT (Hydrodistention Implantation Technique)+ STING

Also known as: Dextranomer/hyaluronic acid

Deflux

Vantris DRUG

vantris will be injected through the working channel of the cystoscope using a special needle into the submucosal space of the ureteral orifice (Deflux to one Vantris to the other side). The technique that will be used is HIT (Hydrodistention Implantation Technique)+ STING

Also known as: Polyacrylate Polyalcohol copolymer

Vantris

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Bilateral VUR of the same grade

You may not qualify if:

• Inability to apply the same technique on both ureteral orifices

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Schneider Medical Center of Israel

Petah Tikva, Israel, Israel

RECRUITING

MeSH Terms

Conditions

Vesico-Ureteral Reflux

Interventions

deflux; dextranomer; Hyaluronic Acid; Vantris; polyacrylate polyalcohol copolymer

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• David Ben-Meir, MD

  Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Ben-Meir, MD

CONTACT

97239253118; davidbm@clalit.org.il

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2013
• First Posted: October 22, 2014
• Study Start: October 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: December 1, 2015
• Last Updated: October 22, 2014

Record last verified: 2014-06

Locations

IL (1)