Preview

Urology Herald

Advanced search

New-generation synthetic implants for the surgical correction of pelvic organ prolapse and stress urinary incontinence: design and testing

https://doi.org/10.21886/2308-6424-2022-10-4-109-119

Abstract

Introduction. Up to 50.0% of postpartum women experience stress urinary incontinence (SUI) and pelvic organ prolapse (POP). One of the most common and pathogenetically substantiated methods for surgical correction of severe SIU and POP is prosthetic reconstruction of the pelvic floor, involves the use of monofilament polypropylene surgical meshes through vaginal or laparoscopic access.. However, this way is associated with specific problems, i.e., primarily mucosal erosions, and pelvic pain. This has served as a trigger for the development of new materials that reduce the likelihood of such side effects.

Objective. To develop the new-generation synthetic implants for surgical correction of stress urinary incontinence and pelvic organ prolapse.

Materials and methods. The main development stages: 1. design of an experimental sample of a synthetic implant (evaluation of basic, physical and mechanical properties). 2. test of an experimental sample obtained in vitro.

Results. A bioresorbable polypropylene ligature delivery system was developed and manufactured in two variants: for the POP correction (mesh tape with a width of 13 – 15 mm) and for the SUI correction (mesh tape with a width of 10 – 11 mm).

Conclusion. Based on the results of the in vitro tests, we can conclude that the synthetic implants developed are able to provide physiological longitudinal (axial) support of the necessary pelvic floor sections and reduce the risk of postoperative complications. Further in vivo studies are required to assess the response of living tissue to the implantation of this type of synthetic implants.

About the Authors

D. D. Shkarupa
St. Petersburg State University – Pirogov Clinic of Advanced Medical Technologies; «Lintex», LLC
Russian Federation

Dmitry D. Shkarupa — M.D., Dr.Sc.(Med), Acting Director, Pirogov Clinic of Advanced Medical Technologies, St. Petersburg State University; Deputy Director for Innovations, «Lintex» LLC.

154 Fontanka River Emb., St. Petersburg, 199034; 6-K Liflandskaya St., Saint-Petersburg, 190020


Competing Interests:

Dmitry D. Shkarupa — deputy director for innovations of «Lintex», LLC.



R. A. Shakhaliev
St. Petersburg State University – Pirogov Clinic of Advanced Medical Technologies
Russian Federation

Rustam A. Shakhaliev — M.D., Gynecologist, Pirogov Clinic of Advanced Medical Technologies, St. Petersburg State University.

154 Fontanka River Emb., St. Petersburg, 199034


Competing Interests:

The authors declare no conflict of interest



A. S. Shulgin
St. Petersburg State University – Pirogov Clinic of Advanced Medical Technologies
Russian Federation

Andrey S. Shulgin — M.D., Сand.Sc. (Med), Urologist, Pirogov Clinic of Advanced Medical Technologies, St. Petersburg State University.

154 Fontanka River Emb., St. Petersburg, 199034


Competing Interests:

The authors declare no conflict of interest



T. S. Filipenko
«Lintex», LLC
Russian Federation

Tatiana S. Filipenko — Сand.Sc.(Tech), Chief Technologist, «Lintex» LLC.

6-K Liflandskaya St., Saint-Petersburg, 190020


Competing Interests:

The authors declare no conflict of interest



N. D. Kubin
St. Petersburg State University – Pirogov Clinic of Advanced Medical Technologies
Russian Federation

Nikita D. Kubin — M.D., Dr.Sc.(Med), Urologist, Pirogov Clinic of Advanced Medical Technologies, St. Petersburg State University.

154 Fontanka River Emb., St. Petersburg, 199034


Competing Interests:

The authors declare no conflict of interest



D. A. Suchkov
St. Petersburg State University – Pirogov Clinic of Advanced Medical Technologies
Russian Federation

Denis A. Suchkov — M.D., Urologist, Pirogov Clinic of Advanced Medical Technologies, St. Petersburg State University.

154 Fontanka River Emb., St. Petersburg, 199034


Competing Interests:

The authors declare no conflict of interest



O. A. Shkarupa
Kirov Military Medical Academy
Russian Federation

Olga A. Shkarupa — Student, Kirov Military Medical Academy.

6 Acad. Lebedeva St., St. Petersburg, 194044


Competing Interests:

The authors declare no conflict of interest



References

1. Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Schaer GN. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Int Urogynecol J. 2010;21(1):5-26. https://doi.org/10.1007/s00192-009-0976-9

2. Mettu JR, Colaco M, Badlani GH. Evidence-based outcomes for mesh-based surgery for pelvic organ prolapse. Curr Opin Urol. 2014;24(4):370-4. https://doi.org/10.1097/MOU.0000000000000063

3. Norton P, Brubaker L. Urinary incontinence in women. Lancet. 2006;367(9504):57-67. https://doi.org/10.1016/S0140-6736(06)67925-7

4. Wu JM, Matthews CA, Conover MM, Pate V, Jonsson Funk M. Lifetime risk of stress urinary incontinence or pelvic organ prolapse surgery. Obstet Gynecol. 2014;123(6):1201-1206. https://doi.org/10.1097/AOG.0000000000000286

5. Petros P. The female pelvic floor. Function, Dysfunction and Management According to the Integral Theory. Moscow: MEDpress-inform; 2016. ISBN 978-5-00030-756-4. (In Russ.)

6. From the American Association of Neurological Surgeons (AANS), American Society of Neuroradiology (ASNR), Cardiovascular and Interventional Radiology Society of Europe (CIRSE), Canadian Interventional Radiology Association (CIRA), Congress of Neurological Surgeons (CNS), European Society of Minimally Invasive Neurological Therapy (ESMINT), European Society of Neuroradiology (ESNR), European Stroke Organization (ESO), Society for Cardiovascular Angiography and Interventions (SCAI), Society of Interventional Radiology (SIR), Society of NeuroInterventional Surgery (SNIS), and World Stroke Organization (WSO), Sacks D, Baxter B, Campbell BCV, Carpenter JS, Cognard C, Dippel D, Eesa M, Fischer U, Hausegger K, Hirsch JA, Shazam Hussain M, Jansen O, Jayaraman MV, Khalessi AA, Kluck BW, Lavine S, Meyers PM, Ramee S, Rüfenacht DA, Schirmer CM, Vorwerk D. Multisociety Consensus Quality Improvement Revised Consensus Statement for Endovascular Therapy of Acute Ischemic Stroke. Int J Stroke. 2018;13(6):612-632. https://doi.org/10.1177/1747493018778713

7. Developed by the Joint Writing Group of the American Urogynecologic Society and the International Urogynecological Association. Joint report on terminology for surgical procedures to treat pelvic organ prolapse. Int Urogynecol J. 2020;31(3):429-463. Erratum in: Int Urogynecol J. 2020;31(6):1283. https://doi.org/10.1007/s00192-020-04236-1

8. Shakhaliev R.A., Shulgin A.S., Kubin N.D., Kuzmina I.N., Suchkov D.A., Shkarupa D.D. Current status of transvaginal mesh implants use in the surgical treatment of stress urinary incontinence and pelvic prolapse. Gynecology. 2022;24(3):174-180. (in Russ.) https://doi.org/10.26442/20795696.2022.3.201423

9. Developed by the Joint Writing Group of the American Urogynecologic Society and the International Urogynecological Association. Joint report on the terminology for surgical procedures to treat stress urinary incontinence in women. Int Urogynecol J. 2020;31(3):465-478. Erratum in: Int Urogynecol J. 2020;31(6):1285. https://doi.org/10.1007/s00192-020-04237-0

10. Keltie K, Elneil S, Monga A, Patrick H, Powell J, Campbell B, Sims AJ. Complications following vaginal mesh procedures for stress urinary incontinence: an 8 year study of 92,246 women. Sci Rep. 2017;7(1):12015. https://doi.org/10.1038/s41598-017-11821-w

11. Ford AA, Rogerson L, Cody JD, Ogah J. Mid-urethral sling operations for stress urinary incontinence in women. Cochrane Database Syst Rev. 2015;(7):CD006375. Update in: Cochrane Database Syst Rev. 2017;7:CD006375. https://doi.org/10.1002/14651858.CD006375.pub3

12. Milani AL, Vollebregt A, Roovers JP, Withagen M. Het gebruik van 'matjes' bij vaginale verzakkingen [The use of mesh in vaginal prolapse]. Ned Tijdschr Geneeskd. 2013;157(31):A6324. (In Dutch) PMID: 23899707

13. MacCraith E, Cunnane EM, Joyce M, Forde JC, O'Brien FJ, Davis NF. Comparison of synthetic mesh erosion and chronic pain rates after surgery for pelvic organ prolapse and stress urinary incontinence: a systematic review. Int Urogynecol J. 2021;32(3):573-580. https://doi.org/10.1007/s00192-020-04612-x

14. Shah HN, Badlani GH. Mesh complications in female pelvic floor reconstructive surgery and their management: A systematic review. Indian J Urol. 2012;28(2):129-53. https://doi.org/10.4103/0970-1591.98453

15. Brown BN, Mani D, Nolfi AL, Liang R, Abramowitch SD, Moalli PA. Characterization of the host inflammatory response following implantation of prolapse mesh in rhesus macaque. Am J Obstet Gynecol. 2015;213(5):668.e1-10. https://doi.org/10.1016/j.ajog.2015.08.002

16. Shkarupa D, Kubin N, Shapovalova E, Zaytseva A. The resurrection of sacrospinous fixation: unilateral apical sling hysteropexy. Int Urogynecol J. 2020;31(2):351-357. https://doi.org/10.1007/s00192-019-03964-3

17. Klinge U, Klosterhalfen B, Conze J, Limberg W, Obolenski B, Ottinger AP, Schumpelick V. Modified mesh for hernia repair that is adapted to the physiology of the abdominal wall. Eur J Surg. 1998;164(12):951-60. https://doi.org/10.1080/110241598750005138

18. Deeken CR, Abdo MS, Frisella MM, Matthews BD. Physicomechanical evaluation of polypropylene, polyester, and polytetrafluoroethylene meshes for inguinal hernia repair. J Am Coll Surg. 2011;212(1):68-79. https://doi.org/10.1016/j.jamcollsurg.2010.09.012

19. van't Riet M, de Vos van Steenwijk PJ, Kleinrensink GJ, Steyerberg EW, Bonjer HJ. Tensile strength of mesh fixation methods in laparoscopic incisional hernia repair. Surg Endosc. 2002;16(12):1713-6. https://doi.org/10.1007/s00464-001-9202-7

20. Conze J, Junge K, Weiss C, Anurov M, Oettinger A, Klinge U, Schumpelick V. New polymer for intra-abdominal meshes--PVDF copolymer. J Biomed Mater Res B Appl Biomater. 2008;87(2):321-8. https://doi.org/10.1002/jbm.b.31106

21. Khandwala S, Jayachandran C. Transvaginal mesh surgery for pelvic organ prolapse--Prolift+M: a prospective clinical trial. Int Urogynecol J. 2011;22(11):1405-11. https://doi.org/10.1007/s00192-011-1482-4

22. Maher C, Baessler K, Glazener CM, Adams EJ, Hagen S. Surgical management of pelvic organ prolapse in women: a short version Cochrane review. Neurourol Urodyn. 2008;27(1):3-12. https://doi.org/10.1002/nau.20542


Review

For citations:


Shkarupa D.D., Shakhaliev R.A., Shulgin A.S., Filipenko T.S., Kubin N.D., Suchkov D.A., Shkarupa O.A. New-generation synthetic implants for the surgical correction of pelvic organ prolapse and stress urinary incontinence: design and testing. Urology Herald. 2022;10(4):109-119. (In Russ.) https://doi.org/10.21886/2308-6424-2022-10-4-109-119

Views: 1035


Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 License.


ISSN 2308-6424 (Online)