A placebo-controlled comparison of the efficiency of triple- and monotherapy in category III B chronic pelvic pain syndrome (CPPS).

OBJECTIVES

To perform a prospective, placebo-controlled study to examine the efficacy of alpha-blocker compared with triple therapy (alpha-blocker, anti-inflammatory, and muscle relaxant) in the treatment of Category IIIB chronic pelvic pain syndrome (Category IIIB CPPS).

MATERIALS AND

METHODS

The study was conducted between September 2004 and December 2005, and included 90 treatment naïve patients, aged 22-42 yr (mean age: 29.1+/-5.2) with Category IIIB CPPS, who were randomized into three groups: group 1, alpha-blocker; group 2, combination of alpha-blocker, anti-inflammatory, and muscle relaxant; group 3, placebo once daily. The patients were treated for 6 mo and were followed up for a further 6 mo. Changes from baseline in the total and domain scores of the NIH Chronic Prostatitis Symptom Index (NIH-CPSI) were evaluated. The primary criterion for response was scoring <or=2 on the NIH-CPSI quality of life item. The secondary criterion for response was >50% reduction in NIH-CPSI pain score.

RESULTS

The NIH-CPSI initial and sixth-month total scores were 23.1 and 10.7, respectively, in group 1, and 21.9 and 9.2, respectively, in group 2. The initial and sixth-month scores remained stable in group 3 (22.9 and 21.9, respectively). There was no statistically significant difference between two treatment arms with respect to efficiency of treatment (p>0.05). The responses in groups 1 and 2 were found durable at the end of 12 mo.

CONCLUSIONS

We found that alpha-blocker monotherapy was as effective and safe as triple therapy in the treatment of Category IIIB CPPS.