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.
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).
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.
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 international. 2024 Jun 13 [Epub]
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
Department of Urology, Daegu Fatima Hospital, Daegu, Korea., Department of Urology, College of Medicine, The Catholic University of Korea, Seoul, Korea., Catholic Integrative Medicine Research Institute, The Catholic University of Korea, Seoul, Korea., College of Pharmacy, Ewha Womans University, Seoul, Korea., Huons Meditech Co., Ltd, Seongnam, Korea.