Skip to main content

Thank you for visiting nature.com. You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript.

  • Article
  • Clinical Research
  • Published:

Evaluation of a low-intensity shockwave therapy for chronic prostatitis type IIIb/chronic pelvic pain syndrome: a double-blind randomized sham-controlled clinical trial

Abstract

Background

Currently, there is no efficacious treatment method for chronic prostatitis type IIIb/chronic pelvic pain syndrome (CP/CPPS). Aim of the study was to investigate and compare the efficacy and safety of low-intensity shockwave therapy (LiST) vs. sham treatment in CP/CPPS patients.

Methods

Patients with CP/CPPS diagnosis were randomized in this prospective, sham-controlled, double-blind study either to the active groups (Group B, C) who received 5000 shockwaves per session with energy flux density 0.1 mJ/mm2 or to the sham group (Group A) who received 5000 shockwaves from a visually identical sham probe. All groups underwent six sessions (once/week). LiST effects on pain, micturition, quality of life (QoL), and erectile function were evaluated at 4, 12, and 24 weeks after treatment. The parameters were investigated using validated questionnaires. Uroflowmetry and post void residual calculation were performed at baseline and at 4- and 12-week FU visit. Prostate mpMRI and PSA measurement were performed at baseline and 12-week FU visit.

Results

Overall, 45 men were randomized to the active (n = 30) and sham groups (n = 15). Regarding impact of LiST in National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) total, pain, and QoL subdomains scores a clear and persistent in all FU timepoints improvement was found compared to sham treatment. NIH-CPSI urinary subdomain, International Prostate Symptom Score [IPSS], PSA, and mpMRI-PIRADS scores did not differ between the two groups. The mean difference between the LiST and sham group in the change of the NIH-CPSI pain-domain score (Q14) from baseline to 12 weeks after final treatment which was 3.3 (95% CI, 1.8, 4.7). Perineal LiST was easy and safe to perform without anesthesia or any side-effects.

Conclusions

LiST seems to be a safe and effective treatment option for CP/CPPS, considerably improving pain and quality of life. Lack of any side-effects, and the potential for repetition make LiST a promising treatment choice for CP/CPPS patients.

This is a preview of subscription content, access via your institution

Access options

Buy this article

Prices may be subject to local taxes which are calculated during checkout

Fig. 1: Patient enrollement proccess and study design.
Fig. 2: NIH-CPSI total score values for active and sham group in all timepoints.

Similar content being viewed by others

References

  1. Schaeffer AJ, Datta NS, Fowler JE, Krieger JN, Litwin MS, Nadler RB, et al. Overview summary statement. Diagnosis and management of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). Urology 2002;60:1–4.

    Article  Google Scholar 

  2. Franco JV, Turk T, Jung JH, Xiao Y-T, Iakhno S, Garrote V, et al. Non-pharmacological interventions for treating chronic prostatitis/chronic pelvic pain syndrome. Cochrane Database Syst Rev. 2018;1:CD012551.

    PubMed  Google Scholar 

  3. Franco JV, Turk T, Jung JH, Xiao Y-T, Iakhno S, Tirapegui FI, et al. Pharmacological interventions for treating chronic prostatitis/chronic pelvic pain syndrome. Cochrane Database Syst Rev. 2019;10:CD012552.

    PubMed  Google Scholar 

  4. Magistro G, Wagenlehner FME, Grabe M, Weidner W, Stief CG, Nickel JC. Contemporary management of chronic prostatitis/chronic pelvic pain syndrome. Eur Urol. 2016;69:286–97.

    Article  Google Scholar 

  5. Doiron RC, Shoskes DA, Nickel JC. Male CP/CPPS: where do we stand? World J Urol. 2019;37:1015–22.

    Article  Google Scholar 

  6. Zimmermann R, Cumpanas A, Hoeltl L, Janetschek G, Stenzl A, Miclea F. Extracorporeal shock-wave therapy for treating chronic pelvic pain syndrome: a feasibility study and the first clinical results. BJU Int. 2008;102:976–80.

    Article  Google Scholar 

  7. Zimmermann R, Cumpanas A, Miclea F, Janetschek G. Extracorporeal shock wave therapy for the treatment of chronic pelvic pain syndrome in males: a randomised, double-blind, placebo-controlled study. Eur Urol. 2009;56:418–24.

    Article  Google Scholar 

  8. Vahdatpour B, Alizadeh F, Moayednia A, Emadi M, Khorami MH, Haghdani S. Efficacy of extracorporeal shock wave therapy for the treatment of chronic pelvic pain syndrome: a randomized, controlled trial. ISRN Urol. 2013. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3755541/.

  9. Zeng X-Y, Liang C, Ye Z-Q. Extracorporeal shock wave treatment for non-inflammatory chronic pelvic pain syndrome: a prospective, randomized and sham-controlled study. Chin Med J. 2012;125:114–8.

    PubMed  Google Scholar 

  10. Yuan P, Ma D, Zhang Y, Gao X, Liu Z, Li R, et al. Efficacy of low-intensity extracorporeal shock wave therapy for the treatment of chronic prostatitis/chronic pelvic pain syndrome: a systematic review and meta-analysis. Neurourol Urodyn. 2019;38:1457–66.

    Article  Google Scholar 

  11. Engeler D, Baranowski PA, Berghmans B, Borovicka J, Cottrell AM, Dinis-Oliveira P, et al. EAU Guidelines 2018. EAU Guidelines Office, Arnhem, The Netherlands. 2018.

  12. Capogrosso P, Frey A, Jensen CFS, Rastrelli G, Russo GI, Torremade J, et al. Low-intensity shock wave therapy in sexual medicine-clinical recommendations from the European Society of Sexual Medicine (ESSM). J Sex Med. 2019;16:1490–505.

    Article  Google Scholar 

  13. Schulz KF, Altman DG, Moher D. CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ 2010;340:c332.

    Article  Google Scholar 

  14. Nickel JC, Shoskes D, Wang Y, Alexander RB, Fowler JE, Zeitlin S, et al. How does the pre-massage and post-massage 2-glass test compare to the Meares-Stamey 4-glass test in men with chronic prostatitis/chronic pelvic pain syndrome? J Urol. 2006;176:119–24.

    Article  Google Scholar 

  15. Mariotto S, Cavalieri E, Amelio E, Ciampa AR, de Prati AC, Marlinghaus E, et al. Extracorporeal shock waves: from lithotripsy to anti-inflammatory action by NO production. Nitric Oxide. 2005;12:89–96.

    Article  CAS  Google Scholar 

  16. Wess OJ. A neural model for chronic pain and pain relief by extracorporeal shock wave treatment. Urol Res. 2008;36:327–34.

    Article  Google Scholar 

  17. Marszalek M, Berger I, Madersbacher S. Low-energy extracorporeal shock wave therapy for chronic pelvic pain syndrome: finally, the magic bullet? Eur Urol. 2009;56:425–6.

    Article  Google Scholar 

  18. Moayednia A, Haghdani S, Khosrawi S, Yousefi E, Vahdatpour B. Long-term effect of extracorporeal shock wave therapy on the treatment of chronic pelvic pain syndrome due to non bacterial prostatitis. J Res Med Sci J Isfahan Univ Med Sci. 2014;19:293–6.

    Google Scholar 

  19. Guu S-J, Geng J-H, Chao I-T, Lin H-T, Lee Y-C, Juan Y-S, et al. Efficacy of low-intensity extracorporeal shock wave therapy on men with chronic pelvic pain syndrome refractory to 3-as therapy. Am J Mens Health. 2018;12:441–52.

    Article  Google Scholar 

  20. Al Edwan GM, Muheilan MM, Atta ONM. Long term efficacy of extracorporeal shock wave therapy [ESWT] for treatment of refractory chronic abacterial prostatitis. Ann Med Surg. 2017;14:12–17.

    Article  Google Scholar 

  21. Pajovic B, Radojevic N, Dimitrovski A, Vukovic M. Comparison of the efficiency of combined extracorporeal shock-wave therapy and triple therapy versus triple therapy itself in Category III B chronic pelvic pain syndrome (CPPS). Aging Male J Int Soc Study Aging Male. 2016;19:202–7.

    Article  CAS  Google Scholar 

  22. Salama AB, Abouelnaga WA. Effect of radial shock wave on chronic pelvic pain syndrome/chronic prostatitis. J Phys Ther Sci. 2018;30:1145–9.

    Article  Google Scholar 

  23. Tripp DA, Curtis Nickel J, Landis JR, Wang YL, Knauss JS. CPCRN Study Group. Predictors of quality of life and pain in chronic prostatitis/chronic pelvic pain syndrome: findings from the National Institutes of Health Chronic Prostatitis Cohort Study. BJU Int. 2004;94:1279–82.

    Article  Google Scholar 

  24. Nickel JC. Chronic prostatitis/chronic pelvic pain syndrome: it is time to change our management and research strategy. BJU Int. 2020;125:479–80.

    Article  Google Scholar 

  25. Rayegani SM, Razzaghi MR, Raeissadat SA, Allameh F, Eliaspour D, Abedi AR, et al. Extracorporeal shockwave therapy combined with drug therapy in chronic pelvic pain syndrome: a randomized clinical trial. Urol J. 2020;17:185–91.

    PubMed  Google Scholar 

  26. Kalyvianakis D, Memmos E, Mykoniatis I, Kapoteli P, Memmos D, Hatzichristou D. Low-intensity shockwave therapy for erectile dysfunction: a randomized clinical trial comparing 2 treatment protocols and the impact of repeating treatment. J Sex Med. 2018;15:334–45.

    Article  Google Scholar 

Download references

Funding

LIST device and the three probes were provided by Dornier MedTech GmbH, Wessling, Germany.

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Ioannis Mykoniatis.

Ethics declarations

Conflict of interest

The authors declare that they have no conflict of interest.

Additional information

Publisher’s note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Supplementary information

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Mykoniatis, I., Kalyvianakis, D., Zilotis, F. et al. Evaluation of a low-intensity shockwave therapy for chronic prostatitis type IIIb/chronic pelvic pain syndrome: a double-blind randomized sham-controlled clinical trial. Prostate Cancer Prostatic Dis 24, 370–379 (2021). https://doi.org/10.1038/s41391-020-00284-2

Download citation

  • Received:

  • Revised:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1038/s41391-020-00284-2

This article is cited by

Search

Quick links