Outcomes and clinical predictors of extracorporeal shock wave therapy in the treatment of chronic prostatitis/chronic pelvic pain syndrome: a prospective randomized double-blind placebo-controlled clinical trial

• Published in: Prostate cancer and prostatic diseases 2022-03, Vol.25 (1), p.93-99
• Main Authors: Sakr, Ahmed M., Fawzi, Amr M., Kamel, Mostafa, Ali, Maged M.
• Format: Article
• Language: English
• Subjects: 692/308/409; 692/699/2768/1753/467; 9/10; Adult; Angina pectoris; Biomedical and Life Sciences; Biomedicine; Cancer Research; Chronic Disease; Chronic pain; Chronic Pain - diagnosis; Chronic Pain - etiology; Chronic Pain - therapy; Clinical trials; Double-blind studies; Evaluation; Extracorporeal Shockwave Therapy - adverse effects; Extracorporeal Shockwave Therapy - methods; Health services; Humans; Laboratories; Lithotripsy; Male; Mental disorders; Microspheres; Pain; Patients; Pelvic Pain - diagnosis; Pelvic Pain - therapy; Pelvis; Placebos; Prospective Studies; Prostate cancer; Prostatic Neoplasms - therapy; Prostatitis; Prostatitis - diagnosis; Prostatitis - etiology; Prostatitis - therapy; Quality of life; Questionnaires; Reproductive Medicine; Shock waves; Signs and symptoms; Statistical analysis; Treatment Outcome
• ISSN: 1365-7852; 1476-5608
• DOI: 10.1038/s41391-021-00464-8

Objectives: To report the one-year results of ESWT on CPPS patients and the possible clinical characteristics that may affect its efficacy. Patients & methods: A prospective randomized clinical study between January 2017 and January 2021 on 155 adult patients with chronic pelvic pain syndrome. All patients were initially evaluated with a thorough history and physical examination. Baseline symptoms evaluation of each participant was assessed using NIH-CPSI score, IPSS, VAS, and IIEF-5 score. Patients were randomized into two groups: a verum treatment group and a placebo treatment group. Patients of verum group in the lithotomy position received a perineally applied ESWT treatment once a week for four weeks with 3000 impulses each. Patients of placebo group received the same therapy head of the same device with a layer of air-filled microspheres to absorb the shock waves. The previously mentioned validated scores were reassessed on regular follow-up visits at one, three, six, and 12 months after the completion of ESWT. Results: A statistically significant improvement was noticed in the mean values of NIH-CPSI, IPSS, VAS, and IIEF-5 of the patients of verum group over the follow-up period with also statistically significant difference between both groups. At the first visit of follow-up after ESWT, 63 (82.8%) patients had ≥6 points decrease in the NIH-CPSI total score, while 13 (17.2%) patients did not. Univariate and multivariate analyses of the clinical characteristics between the responders and non-responders showed that those patients with history of psychological disorders or had higher initial NIH-CPSI score had a significantly lower response rate to ESWT ( p  = 0.005, 0.02 & p  = 0.002, 0.004 respectively). ROC curve of NIH-CPSI score showed that a score of 32 was the cut-off point above which the response to ESWT decreased. Conclusion: ESWT is an effective treatment option for CPPS. Its efficacy remained throughout long-term follow up. High initial NIH-CPSI score and history of psychological problems are significant predictors for it.