Magnetically Controlled Endourethral Artificial Urinary Sphincter

We’re sorry, something doesn't seem to be working properly.

Please try refreshing the page. If that doesn't work, please contact support so we can address the problem.

Abstract

Urinary incontinence is a largely spread disfunction that affects more than 300 million people worldwide. At present, no technological solutions are able to restore continence in a minimally invasive and effective way. In this article the authors report the design, fabrication, and testing of a novel artificial endourethral urinary sphincter able to fully restore continence. The device can be inserted/retracted in a minimally invasive fashion without hospital admission, does not alter the body scheme and can be applied to both women and men. The device core is a unidirectional polymeric valve and a magnetically activated system able to modulate its opening pressure. Bench tests and ex vivo tests on a human cadaver demonstrated that the device is able to fully restore continence and to allow urination when desired. Overall, the proposed system shows a high potential as a technological solution able to restore a normal daily life in patients affected by urinary incontinence.

This is a preview of subscription content, log in to check access.

Figure 1
Figure 2
Figure 3
Figure 4
Figure 5
Figure 6

References

  1. 1.

    Andersson, K. E. Antimuscarinics for treatment of overactive bladder. Lancet Neurol. 3:46–53, 2004.

    CAS  Article  PubMed  Google Scholar 

  2. 2.

    Bauer, R. M., C. Gozzi, W. Hübner, V. W. Nitti, G. Novara, A. Peterson, and C. G. Stief. Contemporary management of postprostatectomy incontinence. Eur. Urol. 59:985–996, 2011.

    Article  PubMed  Google Scholar 

  3. 3.

    Blaivas, J. G., and A. Groutz. Bladder outlet obstruction nomogram for women with lower urinary tract symptomatology. Neurourol. Urodyn. 19:553–564, 2000.

    CAS  Article  PubMed  Google Scholar 

  4. 4.

    Buckley, B. S., and M. C. M. Lapitan. Prevalence of urinary incontinence in men, women, and children—current evidence: findings of the Fourth International Consultation on Incontinence. Urology 76:265–270, 2010.

    Article  PubMed  Google Scholar 

  5. 5.

    Chancellor, M. B. and A. C. Diokno. The Underactive Bladder. Heidelberg: Springer International Publishing, 220 pp., 2016.

  6. 6.

    Chung, E. A state-of-the-art review on the evolution of urinary sphincter devices for the treatment of post-prostatectomy urinary incontinence: past, present and future innovations. J. Med. Eng. Technol. 38:328–332, 2014.

    Article  PubMed  Google Scholar 

  7. 7.

    Chung, E., M. Ranaweera, and R. Cartmill. Newer and novel artificial urinary sphincters (AUS): the development of alternatives to the current AUS device. BJU Int. 110:5–11, 2012.

    Article  PubMed  Google Scholar 

  8. 8.

    Cody, J. D., M. L. Jacobs, K. Richardson, B. Moehrer, and A. Hextall. Oestrogen therapy for urinary incontinence in post‐menopausal women. The Cochrane Library. doi:10.1002/14651858.CD001405.pub3, 2012.

  9. 9.

    Comiter, C. V. Surgery Insight: surgical management of postprostatectomy incontinence—the artificial urinary sphincter and male sling. Nat. Clin. Pract. Urol. 4:615–624, 2007.

    Article  PubMed  Google Scholar 

  10. 10.

    Elliott, D. S., and T. B. Boone. Urethral devices for managing stress urinary incontinence. J. Endourol. 14:79–83, 2000.

    Article  PubMed  Google Scholar 

  11. 11.

    Fiuk, J., Y. Bao, J. G. Calleary, B. F. Schwartz, and J. D. Denstedt. The use of internal stents in chronic ureteral obstruction. J. Urol. 193:1092–1100, 2015.

    Article  PubMed  Google Scholar 

  12. 12.

    Furlani, E. P. Permanent Magnet and Electromechanical Devices: Materials, Analysis, and Applications. San Diego: Academic Press, 518 pp., 2001.

  13. 13.

    Hached, S., Z. Saadaoui, O. Loutochin, A. Garon, J. Corcos, and M. Sawan. Novel, Wirelessly controlled, and adaptive artificial urinary sphincter. IEEE/ASME Trans. Mech. 20:3040–3052, 2015.

    Article  Google Scholar 

  14. 14.

    Herschorn, S., H. Bruschini, C. Comiter, P. Grise, T. Hanus, R. Kirschner-Hermanns, and P. Abrams. Surgical treatment of stress incontinence in men. Neurourol. Urodyn. 29:179–190, 2010.

    Article  PubMed  Google Scholar 

  15. 15.

    Irwin, D. E., Z. S. Kopp, B. Agatep, I. Milsom, and P. Abrams. Worldwide prevalence estimates of lower urinary tract symptoms, overactive bladder, urinary incontinence and bladder outlet obstruction. BJU Int. 108:1132–1138, 2011.

    Article  PubMed  Google Scholar 

  16. 16.

    Kujala, S., A. Pajala, M. Kallioinen, A. Pramila, J. Tuukkanen, and J. Ryhänen. Biocompatibility and strength properties of nitinol shape memory alloy suture in rabbit tendon. Biomaterials 25:353–358, 2004.

    CAS  Article  PubMed  Google Scholar 

  17. 17.

    Lai, L. C., D. R. Tyson, R. V. Clayman, and J. C. Earthman. Encrustation of nanostructured Ti in a simulated urinary tract environment. Mater. Sci. Eng. C 28:460–464, 2008.

    CAS  Article  Google Scholar 

  18. 18.

    Lamraoui, H., A. Bonvilain, G. Robain, H. Combrisson, S. Basrour, A. Moreau-Gaudry, and P. Mozer. Development of a novel artificial urinary sphincter: a versatile automated device. IEEE/ASME Trans. Mech. 15:916–924, 2010.

    Google Scholar 

  19. 19.

    Lucas, M. G., R. J. Bosch, F. C. Burkhard, F. Cruz, T. B. Madden, A. K. Nambiar, and R. S. Pickard. EAU guidelines on surgical treatment of urinary incontinence. Eur. Urol. 62:1118–1129, 2012.

    Article  PubMed  Google Scholar 

  20. 20.

    Markland, A. D., H. E. Richter, C. W. Fwu, P. Eggers, and J. W. Kusek. Prevalence and trends of urinary incontinence in adults in the United States, 2001 to 2008. J. Urol. 186:589–593, 2011.

    Article  PubMed  PubMed Central  Google Scholar 

  21. 21.

    Mata, A., A. J. Fleischman, and S. Roy. Characterization of polydimethylsiloxane (PDMS) properties for biomedical micro/nanosystems. Biomed. Microdev. 7:281–293, 2005.

    CAS  Article  Google Scholar 

  22. 22.

    Mazzocchi, T., L. Ricotti, N. Pinzi, and A. Menciassi. Parametric design, fabrication and validation of one-way polymeric valves for artificial sphincters. Sensors Actuators A: 233:184–194, 2015.

    CAS  Article  Google Scholar 

  23. 23.

    Milsom, I., K. S. Coyne, S. Nicholson, M. Kvasz, C. I. Chen, and A. J. Wein. Global prevalence and economic burden of urgency urinary incontinence: a systematic review. Eur. Urol. 65:79–95, 2014.

    Article  PubMed  Google Scholar 

  24. 24.

    Moore, K. L., A. F. Dalley, and A. M. Agur. Clinically Oriented Anatomy. Philadelphia: Lippincott Williams & Wilkins, 1134 pp, 2013.

  25. 25.

    Morgan, N. B. Medical shape memory alloy applications—the market and its products. Mater. Sci. Eng. A 378:16–23, 2004.

    Article  Google Scholar 

  26. 26.

    Nam, R. K., S. Herschorn, D. A. Loblaw, Y. Liu, L. H. Klotz, L. K. Carr, and C. H. Law. Population based study of long-term rates of surgery for urinary incontinence after radical prostatectomy for prostate cancer. J. Urol. 188:502–506, 2012.

    Article  PubMed  Google Scholar 

  27. 27.

    Ostrowski, I., E. Śledź, J. Ciechan, T. Golabek, J. Bukowczan, M. Przydacz, and P. L. Chłosta. Current interventional management of male stress urinary incontinence following urological procedures. Cent. Eur. J. Urol. 68:340–347, 2015.

    Article  Google Scholar 

  28. 28.

    Patki, P., R. Hamid, P. J. R. Shah, and M. Craggs. Long-term efficacy of AMS 800 artificial urinary sphincter in male patients with urodynamic stress incontinence due to spinal cord lesion. Spinal Cord. 44:297–300, 2006.

    CAS  Article  PubMed  Google Scholar 

  29. 29.

    Pradhan, A., and R. Kearney. Surgical management of stress urinary incontinence. Obstet. Gynaecol. Reprod. Med. 20:207–211, 2010.

    Article  Google Scholar 

  30. 30.

    Ramesh, M. V., D. Raj, and N. Dilraj. Design of wireless real time artificial sphincter control system for urinary incontinence. IEEE International Symposium on Technology Management and Emerging Technologies (ISTMET), pp. 44–49, 2014.

  31. 31.

    Robinson, D., and L. D. Cardozo. The role of estrogens in female lower urinary tract dysfunction. Urology 62:45–51, 2003.

    Article  PubMed  Google Scholar 

  32. 32.

    Schäfer, W., P. Abrams, L. Liao, A. Mattiasson, F. Pesce, A. Spangberg, and P. V. Kerrebroeck. Good urodynamic practices: uroflowmetry, filling cystometry, and pressure-flow studies. Neurourol. Urodyn. 21:261–274, 2002.

    Article  PubMed  Google Scholar 

  33. 33.

    Shabalovskaya, S. A. Surface, corrosion and biocompatibility aspects of Nitinol as an implant material. Biomed. Mater. Eng. 12:69–109, 2002.

    CAS  PubMed  Google Scholar 

  34. 34.

    Thompson, I., and M. R. Kaufman. Nonsurgical interventions for incontinence: where is the evidence? Curr. Bladder Dysfunct. Rep. 5:163–167, 2010.

    Article  Google Scholar 

  35. 35.

    Thüroff, J. W., P. Abrams, K. E. Andersson, W. Artibani, C. R. Chapple, M. J. Drake, and A. Tubaro. EAU guidelines on urinary incontinence. Acta Urol. Esp. (Engl. Ed.) 35:373–388, 2011.

    Article  Google Scholar 

  36. 36.

    Toews, H. A. Intraurethral and intravesical pressures in normal and stress-incontinent women. Obstet. Gynecol. 29:613–624, 1967.

    CAS  PubMed  Google Scholar 

  37. 37.

    Vakalopoulos, I., S. Kampantais, L. Laskaridis, V. Chachopoulos, M. Koptsis, and C. Toutziaris. New artificial urinary sphincter devices in the treatment of male iatrogenic incontinence. Adv. Urol. 2012:439372, 2012.

    Article  PubMed  PubMed Central  Google Scholar 

  38. 38.

    Wein, A. J., and R. R. Rackley. Overactive bladder: a better understanding of pathophysiology, diagnosis and management. J. Urol. 175:S5–S10, 2006.

    Article  PubMed  Google Scholar 

Download references

Acknowledgments

The authors acknowledge the Fondazione Cassa di Risparmio di Lucca (Lucca, Italy) for providing financial support for this study, in the framework of the SUAVES (Artificial urinary system based on bladder and sphincter endoprostheses) and the VESPRO (Protesi di VEscica e Sfintere per il riPristino funzionale dell’apparato uRinariO) projects.

Author information

Affiliations

Authors

Corresponding author

Correspondence to Leonardo Ricotti.

Additional information

Associate Editor Umberto Morbiducci oversaw the review of this article.

Electronic supplementary material

Below is the link to the electronic supplementary material.

Supplementary Video S1 (MP4 13797 kb)

Supplementary Video S2 (MP4 9303 kb)

Supplementary Video S3 (MP4 10986 kb)

Supplementary Video S4 (MP4 9094 kb)

Supplementary Video S5 (MP4 47361 kb)

Supplementary material 6 (PDF 2707 kb)

Rights and permissions

Reprints and Permissions

About this article

Verify currency and authenticity via CrossMark

Cite this article

Mazzocchi, T., Ricotti, L., Pinzi, N. et al. Magnetically Controlled Endourethral Artificial Urinary Sphincter. Ann Biomed Eng 45, 1181–1193 (2017). https://doi.org/10.1007/s10439-016-1784-2

Download citation

Keywords

  • Urinary incontinence
  • Artificial sphincter
  • Magnetic device
  • Minimally invasive therapy
  • Unidirectional valve