Vesico-Ureteral Reflux Clinical Trial
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
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
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
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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