A Prospective Study Comparing the Success Rate of Injection of (DefluxR) Versus (VantrisR) for VUR in Children
Primary Purpose
Vesico-Ureteral Reflux
Status
Unknown status
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Deflux
Vantris
Sponsored by
About this trial
This is an interventional treatment trial for Vesico-Ureteral Reflux focused on measuring VUR
Eligibility Criteria
Inclusion Criteria:
- Bilateral VUR of the same grade
Exclusion Criteria:
- Inability to apply the same technique on both ureteral orifices
Sites / Locations
- Schneider Medical Center of IsraelRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Deflux
Vantris
Arm Description
In each patient, Deflux will be injected into one of the ureteral orifices using the the HIT technique.
Vantris will be injected into the other ureteral orifice using the same technique and the same amount of implant.
Outcomes
Primary Outcome Measures
rate of resolution of VUR using Vantris vs.Deflux
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02271035
Brief Title
A Prospective Study Comparing the Success Rate of Injection of (DefluxR) Versus (VantrisR) for VUR in Children
Official Title
A Prospective Study Comparing the Success Rate of Injection of Dextranomer /Hyaluronic Acid (DefluxR) Versus Polyacrylate Polyalcohol (VantrisR) for Treatment of Bilateral Similar Grade Vesicoureteral Reflux in Children
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
October 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rabin Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
Detailed Description
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.
The first endoscopic treatment was presented in 1981 by Matouschek, who injected Teflon into the submucosa of the ureteral orifice, at the six o'clock position (STING). In this 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).
A review of Deflux therapy for VUR in 63 studies, including 8101 ureters, found a success rate of 51%-79% depending on VUR grade. (grade 1,2 79%, grade 3 72%, grade 4 63%, grade 5 51%) (2).
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vesico-Ureteral Reflux
Keywords
VUR
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Deflux
Arm Type
Active Comparator
Arm Description
In each patient, Deflux will be injected into one of the ureteral orifices using the the HIT technique.
Arm Title
Vantris
Arm Type
Active Comparator
Arm Description
Vantris will be injected into the other ureteral orifice using the same technique and the same amount of implant.
Intervention Type
Drug
Intervention Name(s)
Deflux
Other Intervention Name(s)
Dextranomer/hyaluronic acid
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Vantris
Other Intervention Name(s)
Polyacrylate Polyalcohol copolymer
Intervention Description
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
Primary Outcome Measure Information:
Title
rate of resolution of VUR using Vantris vs.Deflux
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Bilateral VUR of the same grade
Exclusion Criteria:
Inability to apply the same technique on both ureteral orifices
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Ben-Meir, MD
Phone
97239253118
Email
davidbm@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Ben-Meir, MD
Organizational Affiliation
Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Schneider Medical Center of Israel
City
Petach Tikva
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Ben-Meir, MD
Phone
97239253347
Email
davidbm@clalit.org.il
First Name & Middle Initial & Last Name & Degree
David Ben-Meir, MD
12. IPD Sharing Statement
Learn more about this trial
A Prospective Study Comparing the Success Rate of Injection of (DefluxR) Versus (VantrisR) for VUR in Children
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