Elsevier

Urology

Volume 63, Issue 1, January 2004, Pages 13-16
Urology

Adult urology
Role of mepartricin in category III chronic nonbacterial prostatitis/chronic pelvic pain syndrome: a randomized prospective placebo-controlled trial

https://doi.org/10.1016/j.urology.2003.08.006Get rights and content

Abstract

Objectives

To verify the efficacy of mepartricin versus placebo with regard to symptom improvement in patients with chronic nonbacterial prostatitis/chronic pelvic pain syndrome (CPPS) and to verify a relation between hormonal levels and clinical improvement in these patients.

Methods

Twenty-six patients with CPPS were included in our study and randomized into two groups of 13 subjects each. Group 1 patients were treated with mepartricin (40 mg daily) and group 2 patients with placebo. All patients underwent treatment for 60 days. At the beginning and end of therapy, all patients underwent evaluation, including a standardized history, physical examination, luteinizing hormone, follicle-stimulating hormone, testosterone, and beta-estradiol measurements, and a National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) questionnaire.

Results

We observed a decrease in the total NIH-CPSI score from 25.0 to 10.0 in group 1 and from 25.0 to 20.0 in group 2, revealing a 60% and 20% improvement in groups 1 and 2, respectively. A statistically significant decrease was observed with regard to pain (from 11.0 to 4.0 and from 10.0 to 8.0, respectively) and quality of life (from 10.0 to 5.0 and 10.0 to 9.0, respectively). No statistically significant difference was observed in urinary dysfunctions. The luteinizing hormone, follicle-stimulating hormone, and testosterone values were similar in both groups before and after treatment; the 17-beta-estradiol levels were significantly lower in group 1 compared with group 2 at the end of the study.

Conclusions

Mepartricin provides significant symptomatic improvement in men with CPPS compared with placebo. The role of mepartricin in decreasing estrogen plasmatic levels and their concentration in the prostate may account for this clinical improvement.

Section snippets

Material and methods

Between June 2001 and November 2002, 30 patients with CPPS were examined at our outpatient department. All of these patients were eligible for our study and provided written informed consent to the same physician. We did not request institutional review board approval because our study was a spontaneous, and not a financed, trial. We treated 30 patients with CPPS who had already been treated with other drugs with no improvement of their genitourinary symptoms. All the patients agreed to pay the

Results

All 26 patients completed the study. Two patients in group 1 reported episodes of mild epigastralgia associated with nausea. However, it was not severe enough to require the treatment to be discontinued.

Using the scores obtained from the NIH-CPSI questionnaires, we compared the efficacy of mepartricin in group 1 with that of the placebo in group 2. We observed a decrease in the total score from 25.0 to 10.0 in group 1 and from 25.0 to 20.0 in group 2 (Table II). The difference between the two

Comment

The etiology of CPPS is still unknown. Recent reports have excluded bacteria, obligate anaerobes, fungi, Trichomonas, and viruses as pathogenic agents.3, 4 Animal model studies have suggested a genetic predisposition, an increase in estrogen levels, and autoimmune mechanisms.5, 6, 7

The role played by abnormal levels of estrogens and androgens has also been suggested.8 CPPS, in test animals, as well as in humans, might be the result of an increased estrogen/androgen ratio, which in turn leads to

Conclusions

Therapy with mepartricin is well tolerated and provides a significant symptomatic improvement in men with CPPS compared with placebo. Our data showed a statistically significant decrease in estrogen plasmatic levels in the patients treated with mepartricin. Even if we had not measured the estrogen levels in the prostate, we could indirectly suppose a low concentration of them first in the plasmatic fluid and then in the prostate.

The findings of a number of experimental studies seem to confirm

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