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; Woong Jin Bae; U-Syn Ha; Soomin Kim; JunJie Piao; Kyung-Hwa Jeon; Cheong Woon Cheon; Dae Up Kang; Jong Woong Lee; Dongho Shin; Sae Woong Kim

doi:10.1016/j.prnil.2024.06.003

Safety and efficacy of extracorporeal shockwave therapy on chronic prostatitis/chronic pelvic pain syndrome: a prospective, randomized, double-blind, placebo-controlled study

Prostate Int. 2024 Dec;12(4):195-200. doi: 10.1016/j.prnil.2024.06.003. Epub 2024 Jun 13.

Authors

Affiliations

¹ Department of Urology, Daegu Fatima Hospital, Daegu, Korea.
² Department of Urology, College of Medicine, The Catholic University of Korea, Seoul, Korea.
³ Catholic Integrative Medicine Research Institute, The Catholic University of Korea, Seoul, Korea.
⁴ College of Pharmacy, Ewha Womans University, Seoul, Korea.
⁵ Huons 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.

Keywords: Chronic pelvic pain syndrome; Chronic prostatitis; Extracorporeal shock wave therapy.