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

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 ( = 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 ( = 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 ( < 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 ( = 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.