Sakr AM. et al., 2021: 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.
Sakr AM, Fawzi AM, Kamel M, Ali MM.
Urology Department, Faculty of Medicine, Zagazig University, Zagazig, Egypt.
Urology Department, Faculty of Medicine, Zagazig University, Zagazig, Egypt.
Abstract
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.
Prostate Cancer Prostatic Dis. 2021 Oct 11. doi: 10.1038/s41391-021-00464-8. Online ahead of print. PMID: 34635804
Comments 1
Interesting report of an RCT comparing ESW and placebo-treatment of patients with chronic prostatitis (CP) and/or chronic pelvic pain syndrome (CPPS). ESWT was carried out by perineal application of 3000 shockwaves once a week for four weeks. How the placebo-treatment was carried out is clearly described in the report.
Below is a summary of essential recordings before treatment and after 12 months.
Interestingly, the results refer to a group of men with a difficult to treat pain problem. The recorded effect on the different measures is reassuring and if I was clinically active, I would apply this ESWT regimen to patients with severe CP/CPPS. The equipment used was a Duolith SD1, T-TOP (Storz Medical).
It should be noted that the duration of the ESWT effect in this study exceeded that reported in the meta-analysis recently published [1].
Reference
1. Kang Y, Song P, Cao D, Di X, Lu Y, Liu P, Dong Q. The Efficacy and Safety of Extracorporeal Shockwave Therapy versus Acupuncture in the Management of Chronic Prostatitis/Chronic Pelvic Pain Syndrome: Evidence Based on a Network Meta-analysis. Am J Mens Health. 2021 Nov-Dec;15(6):15579883211057998
Hans-Göran Tiselius