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Objective <p>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).</p> Methods <p>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.</p> Results <p>At week 4, the clinical response rate was 78.4% in the P100 group compared with 25% in the control group (P &lt; 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 &lt; 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.</p> Conclusion <p>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.</p>

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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

  • 期刊论文

  • 发表日期：

    2026年1月28日

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  • Haipeng Zhang,
  • Wei Song,
  • Jinliang Ni,
  • Houliang Zhang,
  • Ziming Jiang,
  • Guangcan Yang,
  • Yifan Zhang,
  • Keyi Wang,
  • Yifan Chen,
  • Bo Peng

摘要

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.