Common questions about Deflux (FAQ)
Q: What is the main ingredient in Deflux and what is it derived from?
Deflux is composed of two primary sugar-based materials: dextranomer microspheres and a hyaluronic acid carrier. Official product information notes that the hyaluronic acid used in the formulation is described as non-animal derived.
Q: Is Deflux a surgical procedure or a minimally invasive treatment?
Official documentation describes the Deflux procedure as a minimally invasive treatment. It is performed using a cystoscope, which is a thin, lighted tube inserted through the urethra, and does not typically require an external incision.
Q: Does the material used in Deflux stay in the body permanently?
The implant is intended to provide long-lasting structural support. The hyaluronic acid carrier is naturally absorbed by the body over time and replaced by the child's own tissue. The dextranomer microspheres remain and become surrounded by host connective tissue to maintain the desired stability.
Q: Can Deflux be used for all grades of VUR (Grade I, II, III, IV, V)?
Deflux is officially indicated for the endoscopic treatment of Vesicoureteral Reflux (VUR) in children with grades II, III, and IV. Official documentation does not provide information regarding the safety and effectiveness of the treatment for VUR Grade I or Grade V.
Q: What is the chance that a second Deflux injection might be needed?
Clinical studies indicate that most children achieve resolution of reflux after a single treatment session. However, if the reflux persists, official documentation states that a retreatment session may be considered by the specialist. Research data shows that the overall resolution rate improves significantly after a second or third injection.
Q: Does the procedure involve any external incisions or stitches?
The treatment is administered endoscopically via the urethra, which means the procedure is performed without external incisions or stitches.
Q: What are the most common minor side effects reported after the Deflux procedure?
Official clinical study data reports that the most common adverse events occurring in ge 1% of patients included urinary tract infection (UTI), temporary ureteral dilation, and general discomfort such as nausea, abdominal pain, or painful urination (dysuria).
Q: How common are bladder spasms or a strong urge to urinate after the treatment?
Bladder spasms or an urgency to urinate are commonly reported temporary symptoms after the procedure. Official patient information notes that these post-procedure effects are generally expected to decrease within 24 to 48 hours following the injection.
Q: Are there any known medication interactions that could affect the Deflux procedure or outcome?
Warnings related to the injection procedure note increased bleeding risk in patients with a bleeding disorder or those receiving anticoagulant or antiplatelet agents. These warnings apply specifically to the injection administration.
Q: How long does the Deflux procedure typically take to perform?
The entire procedure is performed while the child is under general anesthesia in a surgical setting. The time required to administer the injection is reported to be approximately 15 to 30 minutes.
Q: Will the patient be hospitalized overnight after receiving Deflux?
Official patient information states that the Deflux procedure is performed as an outpatient treatment. Discharge is generally expected to occur on the same day.
Q: What is the risk of developing a urinary tract infection (UTI) following the injection?
Urinary tract infection (UTI) is a frequently reported adverse event in clinical studies. According to safety data, the incidence of UTIs reported in study populations ranged from approximately 7.6% to 15.4%.
Q: Can the Deflux implant cause the ureter to become blocked?
Ureteral obstruction, which is a blockage of the ureter, is an officially reported adverse event following the procedure. Documentation states that some patients who experienced this event were managed with the temporary placement of a ureteric stent.
Q: How soon can a child return to school or normal activities after the treatment?
Post-procedure information indicates that a return to normal activities is generally expected the day after the procedure. Rest and avoiding strenuous activity are recommended for the remainder of the day of the procedure itself.
Q: Is it normal to experience discomfort or stinging when urinating right after the Deflux procedure?
Yes, patient materials state that due to the nature of the procedure, the urethra and bladder may become irritated. It is common to experience temporary symptoms such as stinging, soreness, or frequent urination during the first 24 to 48 hours.
Q: What are the reported success rates of Deflux treatment?
Clinical research data reports that VUR resolution was observed after one injection in up to 93% of children with VUR grades II-IV in certain studies.
Q: How does the effectiveness of Deflux compare across different VUR grades?
Deflux is indicated for VUR grades II through IV. Clinical studies have reported VUR resolution for patients across these indicated grades, with research results published for higher severity VUR such as Grade IV.
Q: How is Deflux different from open surgical treatment for VUR?
Compared to traditional open surgical procedures, Deflux is classified as a minimally invasive procedure performed through the urethra, resulting in a quicker recovery time. While open surgery may have a slightly higher success rate, the endoscopic injection offers a less invasive option.
Q: Is the material in Deflux visible on medical imaging like X-rays or ultrasounds?
Official clinical and radiologic reports state that the Deflux implants can typically be identified by ultrasound. They are generally not detectable by standard X-ray but may be visible as bright structures on certain types of MRI imaging.
Q: What is the purpose of the follow-up imaging (VCUG) after the procedure?
The follow-up imaging, typically a Voiding Cystourethrogram (VCUG), is used to assess the reflux grade and determine if the VUR was resolved by the treatment.
Q: How long after the injection is the follow-up imaging typically scheduled?
Clinical protocols generally indicate that the initial follow-up VCUG is performed at 3 months post-injection.
Q: Why is Deflux sometimes recommended instead of long-term antibiotic therapy?
Clinical trials were specifically designed to compare the effectiveness of the Deflux procedure with long-term prophylactic antibiotic treatment. Deflux is described as a minimally invasive, one-time treatment alternative that was investigated against the use of daily prophylactic medication.
Q: What symptoms indicate a parent should call the doctor immediately after the procedure?
Official patient information outlines symptoms that should be reported to a healthcare provider immediately, including: a fever (e.g., 101^circF or higher), no urination for 8 to 10 hours, worsening bladder spasms, or severe pain in the back or side.
Q: Does the material in Deflux have any known long-term effects on the bladder tissue?
Long-term follow-up studies have been conducted on patients who received the treatment. Research examining outcomes up to 15 to 25 years has not shown major long-term safety issues in the majority of patients and supports the treatment's long-term stability.
Q: Is Deflux the only substance approved by the FDA for this type of VUR treatment?
Official product information notes that Deflux is recognized as the only injectable agent approved for the treatment of VUR in the United States, as well as in Europe, Australia, and New Zealand.
Q: What research is available regarding the long-term outcomes (e.g., 10+ years) of Deflux?
Yes, the durability and long-term stability of the treatment have been the subject of research. Studies are available that include long-term follow-up results for patients, extending to 15 to 25 years post-procedure.
