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Deflux — Dextranomer / Hyaluronic Acid

Deflux is a dextranomer/hyaluronic-acid implant for endoscopic treatment of vesicoureteral reflux (VUR) grades II–IV in children under US labeling. It was first FDA approved in 2001. The current US product information is maintained by Teleflex; the supplied implant's instructions remain the reference for eligibility, preparation and administration.[1][2]

Its purpose is to improve ureteral coaptation. Radiographic reflux resolution, freedom from febrile infection and preservation of renal function are different outcomes and should be reported separately.

Material and Mechanism​

The sterile gel contains dextranomer 50 mg/mL in stabilized non-animal hyaluronic acid 15 mg/mL. Microspheres range from 80–250 μm. Injection near the ureteral orifice supports the distal ureter, and host connective tissue subsequently surrounds the microspheres. The implant is biodegradable, but visible deposits can persist and calcify.[1]

“Non-animal” does not mean allergy is impossible. The label warns against injection in patients with known allergy to hyaluronic-acid products, streptococcal proteins or dextran. Particle size and biocompatibility should not be used to promise absence of inflammation, migration or obstruction.[1]

Contraindications and Selection​

Current US label contraindications

Do not use in patients with nonfunctional kidney(s), Hutch diverticulum, ureterocele, active voiding dysfunction, ongoing UTI, or primary refluxing megaureters with distal stenosis. Do not inject intravascularly because vascular occlusion may occur.[1]

The label separately identifies uncertainty in children younger than one year, treatment of duplex systems, and use of more than 6 mL in one session (3 mL at each ureteral orifice). Grossly dilated ureteral orifices may make a patient unsuitable. Observational reports of treatment in complex anatomy do not remove these restrictions or make grades I/V part of the US approved indication.[1]

The EAU 2026 guideline favors an individualized strategy based on reflux grade, infection history, renal status, bladder/bowel function and family preference. It recommends reimplantation for persistent high-grade reflux and considers endoscopic correction more suitable for lower grades. Treat associated lower urinary tract dysfunction and constipation as part of the overall pathway; injection is not a universal first-line treatment for every child with VUR.[3]

Administration Principles​

Deflux is injected under cystoscopic guidance by a trained surgeon. The current US IFU describes STING, HIT and double HIT and provides the product-specific equipment and technique. Use those instructions for injection depth, position and coaptation endpoint rather than a fixed dose for every ureter.[1]

  • STING: subureteric injection supporting the ureteral orifice.
  • HIT: intraureteric submucosal injection after hydrodistention identifies the ureteral tunnel.
  • Double HIT: a second, more distal intraureteric injection when needed to complete coaptation.

Six observational comparisons pooled in a 2016 review reported radiographic resolution in 82.5% of HIT-treated versus 71.4% of STING-treated ureters. That finding supports the technique's rationale but does not establish randomized comparative superiority in infection prevention or renal preservation.[4] The frequently cited “92% use double HIT” figure came from 50 respondents to a 2012 survey, with an 18% response rate; it is not a contemporary census of US practice.[5]

Keep the product sterile, do not mix it with other products or resterilize it, and document the agent and injection history. Provide the implant card: Deflux is radiographically opaque and can be mistaken for distal ureteral calculi.[1]

Major Comparative Evidence​

Swedish Reflux Trial: Three Different Endpoints​

This open randomized trial enrolled 203 children aged one to younger than two years with grade III–IV reflux: 69 assigned to antibiotic prophylaxis, 66 to endoscopic treatment and 68 to surveillance. Children in the injection arm continued prophylaxis until postoperative imaging showed absent or nondilating reflux; it was not an injection-without-antibiotics strategy.[6][7][8]

OutcomeFindingInterpretation
Reflux after two yearsResolution or downgrading to grades I–II was reported in 71% after endoscopy, 39% with prophylaxis and 47% with surveillance. Only 52/66 children assigned to endoscopy completed the two-year VCUG.The 71% is not complete reflux eradication or a fully observed all-randomized result. Recurrent dilating reflux was reported in 20% after initial endoscopic improvement.[6]
Febrile UTI in girlsRecurrence affected 10/43 (23%) after endoscopic treatment, 8/43 (19%) with prophylaxis and 24/42 (57%) with surveillance.Endoscopy and prophylaxis reduced infections compared with surveillance in girls. Their difference from each other was not significant; few boys had recurrent febrile UTI.[7]
New renal damageNew damage occurred in 13 girls: five in the endoscopic arm, none with prophylaxis and eight under surveillance; two boys also developed new damage.This does not establish renal protection from injection over prophylaxis. The significantly higher new-damage rate for surveillance versus prophylaxis and the small subgroup counts should not be replaced by a blanket statement that all three treatments were equivalent.[8]

Across the wider evidence base, the 2019 Cochrane review found uncertain additional benefit of endoscopic correction over antibiotic prophylaxis for febrile UTI (RR 0.74, 95% CI 0.31–1.78, low-certainty evidence). An imprecise estimate is not proof that treatment can never reduce infection or renal injury.[9]

Comparisons with Other Bulking Materials​

Two trials in the Cochrane review favored Macroplastique for persistent reflux, but patient-important infection outcomes were inconclusive and renal-parenchymal outcomes were not reported for that comparison. In the larger prospective study, reflux resolved in 182/202 Macroplastique-treated ureters versus 159/197 Deflux-treated ureters. These ureter-level results do not establish equivalent advantages for children, febrile UTI or renal function; Macroplastique's US indication is different.[9][10]

The often quoted grade-specific estimates from 5,527 patients/8,101 renal units combine endoscopic-injection literature across agents. They should not be presented as a Deflux-only efficacy table. The EAU also notes greater concern about delayed obstruction with polyacrylate-polyalcohol copolymer than with Dx/HA; a ranking of material durability alone is insufficient for product selection.[3]

Durability and Interpreting Follow-up​

Large single-center Deflux cohorts report high anatomical resolution rates, often after repeated injections. For example, a cohort of 851 children with 1,287 grade IV–V refluxing units reported first-injection resolution in 895/1,287 (69.5%). Subsequent clinical and ultrasound follow-up extended for a median 8.5 years, but routine VCUG was performed at three months rather than repeatedly in every child throughout that interval. Long clinical follow-up is not continuous proof of radiographic cure.[11]

In another series, 111/150 ureters initially cured and reassessed at one year remained reflux-free. The authors' 46.1% combined one-year success estimate used a selected denominator of 241 ureters, including initial failures, rather than all 337 initially treated ureters. This demonstrates possible recurrence and the importance of follow-up completeness; it is not a universal one-year success rate.[12]

The current label itself reports substantial attrition in its 165-child post-approval study: only 31/165 had complete five-year data. Later “success” could include absence of febrile UTI without routine repeat VCUG. These outcomes should not be equated with imaging-confirmed absence of reflux in every participant.[1]

Safety and Surveillance​

Potential complications include infection, hematuria, dysuria, transient dilation, new contralateral reflux and ureteral obstruction with or without hydronephrosis. Delayed obstruction can require stenting or reimplantation and may affect renal function. The label and published case reports document late presentations, including occasional asymptomatic renal deterioration years after treatment.[1][13]

The severity of possible obstruction matters even when it is uncommon. High-volume injection is not the only setting: a four-center series found five patients requiring stenting among 745 treated, and all had received no more than 1 mL at the relevant injection; four had neurogenic bladder or dysfunctional voiding. That small affected subgroup does not define a universal risk prediction rule.[14]

Histology Is Not a Population Complication Rate​

Giant-cell reactions were found in 94% of a selected 16-child surgical-excision series after failed injection. Calcification was seen in 9/13 treated implants in a different failed-treatment/reimplantation series. These findings describe selected removed tissue, not the frequency of symptomatic granuloma or calcification in all children receiving Deflux.[15][16]

A sonographic volume study had 296 ureters measured at two weeks but only 20 at 24–36 months. Its approximately 65% late volume retention does not prove stability beyond that interval or validate avoiding reflux imaging solely because a mound remains visible.[17]

Arrange follow-up appropriate to reflux severity, renal status and infection history. The IFU suggests postoperative VCUG to assess persistence; an ultrasound-visible mound alone does not establish reflux resolution. New febrile UTI, flank pain, hydronephrosis or deteriorating renal function warrants evaluation. In adults previously treated as children, distinguish a calcified extraluminal implant from a ureteral stone and assess for obstruction.[1][3]

Solesta Is a Separate Product and Indication​

Related Dx/HA technology is marketed as Solesta, originally FDA approved in 2011 for fecal incontinence in adults aged at least 18 who have failed conservative therapy. That does not give Deflux a second interchangeable indication. ASCRS 2023 does not routinely recommend anal bulking injections for FI, a conditional recommendation based on low-quality evidence. See Fecal Incontinence for treatment selection.[18][19]

See also: Macroplastique, Ureteral Reimplantation.

References​

1. Palette Life Sciences/Teleflex. Deflux US Instructions for Use. 90-96532-04, current manufacturer-linked document. Instructions.

2. Teleflex. Deflux US healthcare-professional information. Product website.

3. EAU. Paediatric Urology Guidelines. 2026, section 17, Vesicoureteric Reflux. Guideline chapter.

4. Yap TL, Chen Y, Nah SA, et al. STING Versus HIT Technique of Endoscopic Treatment for Vesicoureteral Reflux: A Systematic Review and Meta-Analysis. Journal of Pediatric Surgery. 2016;51(12):2015-2020. doi:10.1016/j.jpedsurg.2016.09.028

5. Kirsch AJ, Arlen AM, Lackgren G. Current Trends in Dextranomer Hyaluronic Acid Copolymer (Deflux) Injection Technique for Endoscopic Treatment of Vesicoureteral Reflux. Urology. 2014;84(2):462-468. doi:10.1016/j.urology.2014.04.032

6. Holmdahl G, Brandström P, Läckgren G, et al. The Swedish Reflux Trial in Children: II. Vesicoureteral Reflux Outcome. The Journal of Urology. 2010;184(1):280-285. doi:10.1016/j.juro.2010.01.059. See also Brandström P. The Swedish Reflux Trial, doctoral thesis, methods/results. University repository.

7. Brandström P, Esbjörner E, Herthelius M, et al. The Swedish Reflux Trial in Children: III. Urinary Tract Infection Pattern. J Urol. 2010;184:286–291. doi:10.1016/j.juro.2010.01.061.

8. Brandström P, Nevéus T, Sixt R, et al. The Swedish Reflux Trial in Children: IV. Renal Damage. J Urol. 2010;184:292–297. doi:10.1016/j.juro.2010.01.060.

9. Williams G, Hodson EM, Craig JC. Interventions for Primary Vesicoureteric Reflux. Cochrane Database of Systematic Reviews. 2019;2:CD001532. doi:10.1002/14651858.CD001532.pub5

10. Moore K, Bolduc S. Prospective Study of Polydimethylsiloxane vs Dextranomer/Hyaluronic Acid Injection for Treatment of Vesicoureteral Reflux. The Journal of Urology. 2014;192(6):1794-1799. doi:10.1016/j.juro.2014.05.116

11. Friedmacher F, Colhoun E, Puri P. Endoscopic Injection of Dextranomer/Hyaluronic Acid as First Line Treatment in 851 Consecutive Children With High Grade Vesicoureteral Reflux: Efficacy and Long-Term Results. The Journal of Urology. 2018;200(3):650-655. doi:10.1016/j.juro.2018.03.074

12. Lee EK, Gatti JM, DeMarco RT, Murphy JP. Long-Term Followup of Dextranomer/Hyaluronic Acid Injection for Vesicoureteral Reflux: Late Failure Warrants Continued Followup. The Journal of Urology. 2009;181(4):1869-1874. doi:10.1016/j.juro.2008.12.005

13. Pham H, Au J, Jones E. Deflux Calcification Leading to Delayed Obstruction and Loss of Renal Function: A Case Report. Urology. 2022;166:246-249. doi:10.1016/j.urology.2022.04.025

14. Vandersteen DR, Routh JC, Kirsch AJ, et al. Postoperative Ureteral Obstruction After Subureteral Injection of Dextranomer/Hyaluronic Acid Copolymer. The Journal of Urology. 2006;176(4 Pt 1):1593-1595. doi:10.1016/j.juro.2006.06.101

15. Routh JC, Ashley RA, Sebo TJ, et al. Histopathological Changes Associated With Dextranomer/Hyaluronic Acid Injection for Pediatric Vesicoureteral Reflux. The Journal of Urology. 2007;178(4 Pt 2):1707-1710. doi:10.1016/j.juro.2007.03.165

16. Stenberg A, Larsson E, Läckgren G. Endoscopic Treatment With Dextranomer-Hyaluronic Acid for Vesicoureteral Reflux: Histological Findings. The Journal of Urology. 2003;169(3):1109-1113. doi:10.1097/01.ju.0000053013.49676.89

17. McMann LP, Scherz HC, Kirsch AJ. Long-Term Preservation of Dextranomer/Hyaluronic Acid Copolymer Implants After Endoscopic Treatment of Vesicoureteral Reflux in Children: A Sonographic Volumetric Analysis. The Journal of Urology. 2007;177(1):316-320. doi:10.1016/j.juro.2006.08.144

18. US Food and Drug Administration. Solesta, P100014 approval record. May 27, 2011. Approval.

19. Bordeianou LG, Thorsen AJ, Keller DS, et al. The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for the Management of Fecal Incontinence. Diseases of the Colon and Rectum. 2023;66(5):647-661. doi:10.1097/DCR.0000000000002776