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Efficacy of the new P100 extracorporeal shock wave therapy device in the treatment of type IIIB chronic prostatitis/chronic pelvic pain syndrome: a sham treatment controlled, prospective clinical trial

Abstract

Objective

To evaluate the therapeutic efficacy and clinical applicability of the novel P100 extracorporeal shock wave therapy (ESWT) device in the treatment of type IIIB chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS).

Methods

In this randomized, single-blind, sham-controlled trial, 83 patients with type IIIB CP/CPPS were enrolled and randomly assigned to either the P100 treatment group (n = 51) or the control group (n = 32). Patients in the treatment group received four weekly low-intensity ESWT sessions (0.2 mJ/mm²), while the control group received identical procedures with shock transmission blocked. The primary endpoint was the clinical response rate (≥6-point reduction in NIH-CPSI score) at week 4; week 8 outcomes were further analyzed to assess sustained efficacy. Secondary endpoints included IPSS, IIEF-5, and VAS scores.

Results

At week 4, the clinical response rate was 78.4% in the P100 group compared with 25% in the control group (P < 0.001). Median NIH-CPSI scores decreased from 35 at baseline to 13 at week 4 and 12 at week 8, indicating sustained improvement. Significant reductions in PDS, IPSS, and VAS scores were observed as early as week 2 (P < 0.05), and symptom relief remained stable through week 8 without rebound. Exploratory analyses suggest that lower baseline estradiol levels and lower E2/T ratios may be associated with more sustained improvements in erectile function. No treatment-related adverse events were reported.

Conclusion

The P100 ESWT device provided rapid, significant, and sustained symptom relief for type IIIB CP/CPPS, particularly in pain and urinary domains. Hormonal balance (E2/T) may influence the long-term maintenance of erectile function after ESWT. These findings support P100 as a safe and effective non-invasive therapeutic option for CP/CPPS, warranting further validation in larger studies with longer-term follow-up.

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Fig. 1: CONSORT flow chart of participant disposition.
Fig. 2: Efficacy and Sustained Therapeutic Effect of P100 ESWT for Type IIIB CP/CPPS.

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Data availability

All raw data and informed consent for this study are available upon request from corresponding authors.

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Acknowledgements

We would like to express our gratitude to Wikkon Precision Technologies for developing and providing the new device, as well as for the training and technical support during the pilot phase. At the same time, we are very grateful for the company’s support in allowing us to independently conduct the subsequent clinical trial, which ensured the reliability and fairness of this study. To ensure the independence and transparency of the study, all participants adhered to strict conflict of interest management procedures throughout the research process. The study design, data collection, analysis, and interpretation of results were conducted solely by the research team, with no intervention or influence from the sponsor. Furthermore, no direct or indirect financial support was received from the sponsor by any of the researchers during the study. All potential conflicts of interest and ethical considerations have been disclosed in the manuscript. The results and conclusions of this study are entirely based on data and scientific evidence, and the research team ensures that all findings are independent of the sponsor.

Funding

The study was funded by the Program for Research-oriented Physicians of Shanghai Tenth People’s Hospital (grant number 2023YJXYSA016).

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Authors and Affiliations

Authors

Contributions

HZ, WS, and JN contributed to the study conception and design, and data acquisition. HoZ, ZJ, GY, and YZ performed the data analysis and interpretation. HZ and WS drafted the manuscript. KW, YC, and BP provided critical revision of the manuscript for important intellectual content and supervised the study. All authors read and approved the final manuscript.

Corresponding authors

Correspondence to Keyi Wang, Yifan Chen or Bo Peng.

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Competing interests

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Peng Bo reports that the project was funded by the Shanghai Tenth People’s Hospital’s Research Physician Programme and technical support for the P100 Shockwave Therapy Instrument from Wikkon Precision Technologies. To ensure the independence and transparency of the study, all participants adhered to strict conflict of interest management procedures throughout the research process. The study design, data collection, analysis, and interpretation of results were conducted solely by the research team, with no intervention or influence from the sponsor. Furthermore, no direct or indirect financial support was received from the sponsor by any of the researchers during the study. All potential conflicts of interest and ethical considerations have been disclosed in the manuscript. The results and conclusions of this study are entirely based on data and scientific evidence, and the research team ensures that all findings are independent of the sponsor. There are no disputes of interest and we would like to express our gratitude.

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Zhang, H., Song, W., Ni, J. et al. Efficacy of the new P100 extracorporeal shock wave therapy device in the treatment of type IIIB chronic prostatitis/chronic pelvic pain syndrome: a sham treatment controlled, prospective clinical trial. Prostate Cancer Prostatic Dis (2026). https://doi.org/10.1038/s41391-026-01072-0

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