Hur KJ. et al., 2024: Safety and efficacy of extracorporeal shockwave therapy on chronic prostatitis/chronic pelvic pain syndrome: a prospective, randomized, double-blind, placebo-controlled study.
Kyung Jae Hur 1, Woong Jin Bae 2, U-Syn Ha 2, Soomin Kim 3, JunJie Piao 3, Kyung-Hwa Jeon 4, Cheong Woon Cheon 5, Dae Up Kang 5, Jong Woong Lee 5, Dongho Shin 2, Sae Woong Kim 2
1Department of Urology, Daegu Fatima Hospital, Daegu, Korea.
2Department of Urology, College of Medicine, The Catholic University of Korea, Seoul, Korea.
3Catholic Integrative Medicine Research Institute, The Catholic University of Korea, Seoul, Korea.
4College of Pharmacy, Ewha Womans University, Seoul, Korea.
5Huons Meditech Co., Ltd, Seongnam, Korea.
Abstract
Purpose: This study aimed to investigate the efficacy and safety of extracorporeal shock wave therapy (ESWT) over an 8-week period in individuals diagnosed with chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) compared to a control group.
Materials and methods: This prospective, double-blind, placebo-controlled study enrolled 46 participants diagnosed with CP/CPPS, who were randomly assigned to either the treatment group or the control group in a 2:1 ratio. In the treatment group, ESWT was administered at the perineum once a week for 8 weeks. CP/CPPS-related symptoms were assessed using the National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI). Pain and erectile function were measured using the Visual Analogue Scale (VAS) and the International Index of Erectile Function-Erectile Function (IIEF-EF).
Results: The primary efficacy assessment variable, the change in NIH-CPSI total score at 4 weeks after the end of the 8-week treatment compared to baseline, was significantly improved (P = 0.0225) in the treatment group (-11.27 ± 8.39) compared to the control group (-5.44 ± 5.73). Regarding the secondary efficacy assessment variables, the treatment group showed significant decreases compared to the control group in change in NIH-CPSI total score (P = 0.0055) at the end of the 8-week treatment compared to baseline, along with significant decreases in pain and quality of life scores, as well as VAS assessments at the end of the 8-week treatment and 4 weeks after the end of treatment (P < 0.05). Moreover, in the evaluation conducted to assess improvement in sexual function, the treatment group showed a significant increase compared to baseline than the control group in the IIEF total score at 4 weeks after the end of the treatment (P = 0.0364). No patients experienced severe side effects related to ESWT during the therapeutic period or the follow-up duration.
Conclusions: The efficacy assessment in this clinical trial indicates that extracorporeal shock wave therapy is expected to have a symptomic improvement effect on CP/CPPS
Prostate Int. 2024 Dec;12(4):195-200. doi: 10.1016/j.prnil.2024.06.003. Epub 2024 Jun 13.
PMID: 39735201
Free PMC article.
Comments 1
Study Objective
The study aimed to evaluate the safety and effectiveness of extracorporeal shock wave therapy (ESWT) in treating chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS).
Methodology
In a prospective, double-blind, placebo-controlled trial. 46 men diagnosed with CP/CPPS were randomized in a 2:1 ratio to receive either ESWT or a placebo. ESWT administered to the perineum once weekly for 8 weeks using the Impo88, an electromagnetic focal ESWT-device produced in South Korea. Overall 3000 impulsed were applied at 3 Hz with 0.25 mJ/mm2 .
Assessments: Symptom evaluation using the National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI), pain measured by Visual Analogue Scale (VAS), and sexual function assessed via the International Index of Erectile Function (IIEF).
Key Findings
Symptom Improvement: The ESWT group showed a significant reduction in NIH-CPSI total scores compared to the placebo group at both the end of treatment and 4 weeks post-treatment.
Pain Reduction: Significant decreases in pain scores (VAS) were observed in the ESWT group.
Quality of Life: Improvements in quality of life-scores were noted in the treatment group.
Sexual Function: The ESWT group experienced a significant increase in IIEF scores 4 weeks after treatment completion.
Safety: No severe side effects related to ESWT were reported during the treatment or follow-up periods.
Conclusion
Extracorporeal shock wave therapy appears to be a safe and effective treatment option for patients with CP/CPPS, leading to improvements in symptoms, pain, quality of life, and sexual function. This study was well designed. It seems that the results can be transferred to other shock wave devices (i.e Storz-Medical Duolith SD) which can provide the same setting. Nevertheless, the sample size is small and the follow up was relatively short with 8 weeks.
Jens Rassweiler