Read answers to common questions
about Deflux

Common questions about Deflux — a non-surgical treatment for VUR

Does Deflux treatment require surgery?

Deflux endoscopic treatment is a non-surgical, minimally invasive injection procedure. Your doctor will use a small camera called a cystoscope (a type of endoscope used to view the bladder) to properly place the gel. The gel is injected where the ureter joins the bladder. During the procedure, your child may be under general anesthesia. The treatment usually takes about 15 minutes and allows children to go back to normal activities the next day.1

How do I know Deflux will work for my child?

Most children have success after one injection, while some may need more injection procedures. A 2011 study shows Deflux was proven effective in 93% of children, with no febrile urinary tract infections (febrile UTIs) after one injection.2

How safe is Deflux?

Since 2001, Deflux has been used to treat vesicoureteral reflux (VUR) grades 2-4. The gel is similar to the natural starches, sugars and tissues in the body. Deflux is made from two tissue-friendly polysaccharides (types of sugar molecules – hyaluronic acid (HA) and dextranomer (Dx).

The hyaluronic acid (HA) is naturally broken down (biodegraded) over a short time and replaced by the body’s own material, while the dextranomer remains in place longer. The HA in Deflux is Non-Animal Stabilized Hyaluronic Acid (NASHA®), a patented HA technology that is made from non-animal bacteria and crosslinked specifically for optimal stabilization. NASHA has been used safely for VUR for over two decades and has been used in more than 40 million procedures worldwide, often as a dermal filler.3

Treatment with Deflux has some potential risks. There is a small risk of infection and bleeding from the procedure. Although a rare event, the gel might block the ureter and not allow the urine to flow down from the kidneys. You should ask your pediatric urologist (VUR doctor) about these side effects.

Who should not be treated with Deflux?

Your pediatric urologist can help with determining whether Deflux is right for your child.
Children with certain types of medical conditions should not be treated with Deflux:

  • Non-functional kidney(s)
  • Hutch diverticulum (bulging or herniation in the skin of the bladder)
  • Ureterocele (swelling at the bottom of the ureter)
  • Acute voiding dysfunction (disorder in eliminating urine)
  • Ongoing UTIs

Why should I get my child treated for VUR if my pediatrician doctor says he or she may grow out of it?

Some children can outgrow VUR, usually when it’s a mild case. This is what your doctor or pediatric urologist calls spontaneous resolution.

The likelihood of spontaneous resolution varies according to a child’s age, grade of VUR, and whether the VUR is on one ureter or both.

VUR Resolution Chart – Percent Chance of Reflux Resolution After A Specified Number of Years4

American Urological Association

Grade Age 1 Year 5 Years
Grade 3 – One Ureter 2-5 Years Old 13.4% 51.3%
Grade 3 – Both Ureters 2-5 Years Old 7.0% 30.5%
Grade 3 – One Ureter 5-10 Years Old 10.8% 43.6%
Grade 3- Both Ureters 5-10 Years Old 2.6% 12.5%

Treatment is important to protect the kidneys. Kidney infections may cause damage or scarring in the kidneys, which can result in poor kidney function and high blood pressure.

VUR Patients with Renal Scarring Developed Further Conditions5

Condition VUR (No Renal Scarring) VUR (Renal Scarring)
Proteinuria (Protein in Urine) 1.6% 5.1%
Kidney Disease 0.0% 2.0%
Hypertension (High Blood Pressure) 1.0% 2.8%

What is the best treatment for my child?

This is a discussion you should have with your doctor and a pediatric urologist. In most cases, you have the option of antibiotics, endoscopic treatment with Deflux, or open surgery—all of which have their specific benefits and risks. You want to make sure you understand all that’s involved, from treatment to required follow-up. Only then can you decide what’s right for your family.

References:
  1. Cerwinka WH, Scherz HC, Kirsch AJ. Endoscopic treatment of vesicoureteral reflux with dextranomer/hyaluronic acid in children. Adv Urol. 2008;1-7.
  2. Stenberg A, Läckgren G. Treatment of vesicoureteral reflux in children using stabilized non-animal hyaluronic acid/dextranomer gel (NASHA/Dx): a long-term observational study. J Pediatr Urol. 2007;3(2):80-85.
  3. Ogan K, Pohl HG, Carlson D, Belman AB, Rushton HG. Parental preferences in the management of vesicoureteral reflux. J Urol. 2001;166(1):240-243.
  4. Sung J, Skoog S. Surgical management of vesicoureteral reflux in children. Pediatr Nephrol. 2012;27:551-561.
  5. Data on file.
  6. Deflux [prescribing information]. Santa Barbara, CA: Palette Life Sciences, Inc.; 2019.
X