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Randomized clinical trial between polyacrylate-polyalcohol copolymer (PPC) and dextranomer-hyaluronic acid copolymer (Dx/HA) as bulking agents for endoscopic treatment of primary vesicoureteral reflux (VUR)

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Abstract

Objective

To compare the radiological and clinical outcomes of endoscopic treatment of primary VUR using polyacrylate-polyalcohol copolymer (PPC-Vantris®) or dextranomer-hyaluronic acid copolymer (Dx/HA-Deflux®).

Materials and methods

From October 2014 to April 2017, patients with primary VUR grade III to V that needed endoscopic treatment (ET) were eligible for this randomized clinical trial. We excluded toilet-trained patients with lower urinary tract symptoms. Patients were randomized and allocated into two groups: PPC group and Dx/HA group. After endoscopic treatment a voiding cystourethrography (VCUG) was performed at 6 months; if VUR was still present a second ET was performed. Radiological success was considered if postoperative VUR grade was 0 and clinical success rate was considered if no more fUTI appeared during follow-up.

Results

Forty-six patients were eligible but 2 did not accept the trial. Forty-four patients with 73 refluxing ureters were included. PPC: 34 refluxing ureters; and Dx/HA: 39 refluxing ureters. Both groups were statistically homogeneous and comparable. Mean follow-up was 27.6 months. Radiological success rate (82.2%) and clinical success rate (92.3%) were similar in both groups (p > 0.05). The volume of bulking agent used in those successfully treated was greater in Dx/HA group (p < 0.05). Distal ureter was excise in all cases of ureteral reimplantation after PPC treatment; however, distal ureter was preserved in all ureters reimplanted after Dx/HA injection.

Conclusion

PPC and Dx/HA had similar outcomes, but we must warn that ureteral reimplantation after endoscopic treatment with PPC is difficult because of the periureteral fibrosis.

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Funding

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Authors and Affiliations

  1. Pediatric Urology Division, Pediatric Surgery Department, Hospital Sant Joan de Déu, University of Barcelona, Passeig Sant Joan de Déu 2, 08950, Barcelona, Spain

    L. García-Aparicio, O. Martin, S. Pérez-Bertólez, J. Arboleda, A. Soria & X. Tarrado

  2. Anesthesiology Department, Hospital Sant Joan de Déu, University of Barcelona, Passeig Sant Joan de Déu 2, Barcelona, 08950, Spain

    E. Blázquez-Gómez

Authors
  1. L. García-Aparicio
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  2. E. Blázquez-Gómez
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  3. O. Martin
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  4. S. Pérez-Bertólez
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  5. J. Arboleda
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  6. A. Soria
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  7. X. Tarrado
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Contributions

LG-A: protocol/project development, data collection or management, data analysis, manuscript writing/editing. EB-G: protocol/project development, data analysis, manuscript writing/editing. OM-S: protocol/project development, data collection or management, data analysis. SP-B: protocol/project development, data collection or management. JA: data collection or management. AS: data collection or management. XT: protocol/project development.

Corresponding author

Correspondence to L. García-Aparicio.

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Conflict of interest

We have no conflict of interest.

Ethical approval

All procedures performed in this study were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. The study was approved by our Research Ethical Board number: 45-14.

Informed consent

All patients included in the study signed the informed consent.

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García-Aparicio, L., Blázquez-Gómez, E., Martin, O. et al. Randomized clinical trial between polyacrylate-polyalcohol copolymer (PPC) and dextranomer-hyaluronic acid copolymer (Dx/HA) as bulking agents for endoscopic treatment of primary vesicoureteral reflux (VUR). World J Urol 36, 1651–1656 (2018). https://doi.org/10.1007/s00345-018-2314-7

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  • DOI: https://doi.org/10.1007/s00345-018-2314-7

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