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.