WASHINGTON, D.C.—Silodosin may be an effective treatment for moderate or severe chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS), researchers reported at the American Urological Association 2011 annual meeting.
In a 12-week double-blind, placebo-controlled study that enrolled 151 patients (mean age 48.2 years) with moderate or severe CP/CPPS, J. Curtis Nickel, MD, of Queen’s University in Kingston, Ont., and colleagues found that once-daily administration of silodosin 4 mg resulted in significant decreases in National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) total symptoms and quality of life scores. The treatment also resulted in significant increases in Medical Outcomes Short Form 12 (SF-12) physical component scores compared with placebo.
Dr. Nickel’s group randomly assigned patients to receive silodosin 4 mg (52 patients), silodosin 8 mg (45 patients), or placebo (54 patients). Of the 151 subjects, 76.2% completed the study.
At baseline, the silodosin 4 mg, silodosin 8 mg, and placebo groups had NIH-CPSI total scores of 26.0, 26.8, and 27.9, respectively. The mean score decreased significantly by 12.1 in the silodosin 4 mg, but decreased nonsignificantly by 10.2 and 8.5 in the silodosin 8 mg and placebo groups, respectively.
In addition, 56% of patients receiving silodosin 4 mg reported marked or moderate improvement during global response assessment compared with 29% of placebo recipients.
Compared with placebo, silodosin 4 mg was associated with significant improvement in mean NIH-CPSI urinary symptom score (-2.2 vs -1.3), NIH-CPSI quality of life impact score (-4.1 vs -2.7), and SF-12 physical component score (4.2 vs. 1.7).
Silodosin 4 mg was well tolerated, with treatment-related incidences of dizziness and headache lower than those for placebo, the researchers reported. Moreover, 26.9% of patients treated with silodosin 4 mg experienced retrograde ejaculation (placebo, 1.9%).
“The results of this study support the use of silodosin 4 mg to relieve symptoms and improve quality of life in patients with moderate to severe CP/CPPS,” the researchers concluded in a poster presentation.
They noted that treatment with silodosin 8 mg instead of 4 mg provided no additional clinical benefit.