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

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ClinicalTrials.gov Identifier: NCT02271035
Recruitment Status : Unknown
Verified June 2014 by Rabin Medical Center.
Recruitment status was:  Recruiting
First Posted : October 22, 2014
Last Update Posted : October 22, 2014
Sponsor:
Information provided by (Responsible Party):
Rabin Medical Center

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


Condition or disease Intervention/treatment Phase
Vesico-Ureteral Reflux Drug: Deflux Drug: Vantris Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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 Start Date : October 2014
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arm Intervention/treatment
Active Comparator: Deflux
In each patient, Deflux will be injected into one of the ureteral orifices using the the HIT technique.
Drug: Deflux
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
Other Name: Dextranomer/hyaluronic acid

Active Comparator: Vantris
Vantris will be injected into the other ureteral orifice using the same technique and the same amount of implant.
Drug: Vantris
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
Other Name: Polyacrylate Polyalcohol copolymer




Primary Outcome Measures :
  1. rate of resolution of VUR using Vantris vs.Deflux [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Bilateral VUR of the same grade

Exclusion Criteria:

  • Inability to apply the same technique on both ureteral orifices

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02271035


Contacts
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Contact: David Ben-Meir, MD 97239253118 davidbm@clalit.org.il

Locations
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Israel
Schneider Medical Center of Israel Recruiting
Petach Tikva, Israel
Contact: David Ben-Meir, MD    97239253347    davidbm@clalit.org.il   
Principal Investigator: David Ben-Meir, MD         
Sponsors and Collaborators
Rabin Medical Center
Investigators
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Principal Investigator: David Ben-Meir, MD Investigator
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Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT02271035    
Other Study ID Numbers: Rabin Medical Center
First Posted: October 22, 2014    Key Record Dates
Last Update Posted: October 22, 2014
Last Verified: June 2014
Keywords provided by Rabin Medical Center:
VUR
Additional relevant MeSH terms:
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Vesico-Ureteral Reflux
Urinary Bladder Diseases
Urologic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents