An open randomized study of the effectiveness of treatment of males with chronic prostatitis (categories II and IIIA) applying levofloxacin and tamsulosin combined with IndigalPlus

Kogan M.I., Kul'chavenya E.V., Kaprin A.D., Novikov A.I., Krupin V.N., Ibishev H.S., Rodygin L.M., Kiselev V.I., Druh V.M.

Introduction. The article presents the results of a comparative study of the evaluation of the effectiveness and safety of a combination of Levofloxacin and Tamsulosin with IndigalPlus.

Materials and methods. Patients diagnosed with chronic prostatitis, CP (n=121, stages II and IIIA) were randomized into four parallel groups containing 30 patients. Patients from the first group (CP stage II) had been receiving Levofloxacin (500 mg per day) for one month and IndigalPlus (2 capsules twice a day) for three months. Patients from the second group (CP stage II) had been receiving Levofloxacin (500 mg per day) for one month. Patients from the third group (CP stage IIIA) had been receiving Tamsuloin (400 mg per day) and IndigalPlus (2 capsules twice a day) for three months. Patients from the fourth group (CP stage IIIA) had been receiving Tamsuloin (400 mg per day) for three months. The effectiveness of the therapy was evaluated by the following parameters: urodynamics, changes in prostate volume, timing and completeness of biological debridement, and also comparison of life quality, sexual function and the intensity of obstructive and irritative symptom scores, according to IPSS, NIH-CPSI and IIEF questionnaires.

Results. According to the data collected from urofluorimetry after 6 months of the study, an increase in the peak urinary flow rate (Qmax) and average urinary flow rate (Qave) has significantly grown by more than 20% in the first and in the third groups. Patients from there groups had been taking Levofloxacin and Tamsuloin in combination with IndigalPlus. It was also shown that in comparison with Levofloxacin only therapy course, three-months course of IndigalPlus and Levofloxacin combination therapy leads to a significant decrease in leukocyte content of prostate secretions, bacterial contamination, and also in the severity of urination disorders, which were evaluated by the IPSS total score. During the study, four unwanted events (UE) were registered in all groups. No significant differences in the frequency of the UE were found.

Results. Drug IndigalPlus is effective for the treatment of chronic prostatitis and is well tolerated by patients.?e absence of serious UE, biochemical deviations, and deviations in blood and urine tests have proven the safety of the therapy administered.

Authors declare lack of the possible conflicts of interests.

AttachmentSize
Download1.61 MB
chronic prostatitis, chronic pelvic pain, treatment, levofloxacin, tamsulosin, IndigalPlus