TCAS 12. The study on the safety and efficacy of GRQLX sonostate in treating chronic prostatitis

A new dev ice R-QLX sonostat was made in Pecking Guoruihuihuang Medical Equipment Co., Ltd., mainly used for treating prostatitis and BPH approved by China SFDA.Aim of this study is to investigate the safety and efficacy of GR-QLX sonostat in treating chronic prostatitis (CP), the principles clinical trial were performed in double-blind randomized multicenter study from Jan 2010 to July 2010 in two different medical centers.

The 96 cases pf patients with CP standards were recruited the cinical trial of GR-QLX sonostat. Each hospital has 48 cases with 24 test cases and 24 control cases. The principles of this clinical trial are random, double-blind, multicenter. Patients aged 18- 50 years old and complained CP more than 3 months without received the other medical or instrumental treatment on CP 4 weeks previously and signed the informed consent were enrolled this study. Ten min treatment using R-QLX sonostat was performed 3 times a week for 2 weeks for each of patients. NIHCPSI, quality of life (QOL), urine and EPS analysis, were used for evaluation the efficacy of therapy and adverse events were evaluated also.

In the results the therapeutic effect of test group is better than control group considering the NIH-CPSI scores in treating CP (70.83% vs. 25%, P<0.001). For safety index, leucocyte numbers, and lecithin index, there is no significant difference between these two groups. The influence on vital signs is not observed in this trial.

These results suggested that GR-QLX sonostat therapy on CP is safe and effective for treating CP, the further study is recommended.