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

Clalit Health Services

Status and phase: Unknown; Phase 4

Conditions: Vesico-Ureteral Reflux

Treatments: Drug: Vantris; Drug: Deflux

Study type: Interventional

Funder types: Other

Identifiers

NCT02271035

Rabin Medical Center

Details and patient eligibility

About

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

Full 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

Enrollment: 100 estimated patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Bilateral VUR of the same grade

Exclusion criteria

• Inability to apply the same technique on both ureteral orifices

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

100 participants in 2 patient groups

Deflux

Active Comparator group

Description:

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

Treatment:

Drug: Deflux

Vantris

Active Comparator group

Description:

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

Treatment:

Drug: Vantris