The Journal of urology · 2004
Treatment of chronic prostatitis/chronic pelvic pain syndrome with tamsulosin: a randomized double blind trial.
Клиническое исследованиеКлиническое исследование II фазыСтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Nickel J Curtis, Narayan Perinchery, McKay John, Doyle Caroline
Аннотация
PURPOSE: We compared the efficacy of tamsulosin with placebo for the treatment of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS).
MATERIALS AND METHODS: In a double blind phase II trial, 58 patients 55 years old or younger with moderate to severe CP/CPPS were randomized to receive 0.4 mg tamsulosin or placebo for 6 weeks. Patients were assessed on days -14 and -1 during a 2-week washout, and on days 15 and 45. The primary end point was the change from baseline in total National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) score on day 45. Secondary end points were the change from baseline in total NIH-CPSI score on day 15 and the change from baseline in pain, urinary symptoms and quality of life/impact domains of the NIH-CPSI on days 15 and 45. Analyses of responders were performed post hoc.
RESULTS: On day 45 the treatment effect (difference between treatment groups in change from baseline) was -3.6 (p = 0.04) in favor of tamsulosin. The overall effect of tamsulosin was a function of the baseline total NIH-CPSI score. Treatment effect increased significantly as the baseline score increased (for total NIH-CPSI p <0.01). Tamsulosin efficacy was superior to placebo at the 75th percentile of baseline score for the total NIH-CPSI score (-8.3, p <0.01), the pain domain (-2.9, p = 0.02), the urinary symptoms domain (-2.3, p <0.01) and the impact/quality of life domain (-2.1, p = 0.02). The efficacy of tamsulosin increased with time (no significant treatment difference at 15 days) and tamsulosin was well tolerated.
CONCLUSIONS: Tamsulosin was superior to placebo in providing symptomatic relief in men with CP/CPPS, particularly in those with more severe symptoms.
MATERIALS AND METHODS: In a double blind phase II trial, 58 patients 55 years old or younger with moderate to severe CP/CPPS were randomized to receive 0.4 mg tamsulosin or placebo for 6 weeks. Patients were assessed on days -14 and -1 during a 2-week washout, and on days 15 and 45. The primary end point was the change from baseline in total National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) score on day 45. Secondary end points were the change from baseline in total NIH-CPSI score on day 15 and the change from baseline in pain, urinary symptoms and quality of life/impact domains of the NIH-CPSI on days 15 and 45. Analyses of responders were performed post hoc.
RESULTS: On day 45 the treatment effect (difference between treatment groups in change from baseline) was -3.6 (p = 0.04) in favor of tamsulosin. The overall effect of tamsulosin was a function of the baseline total NIH-CPSI score. Treatment effect increased significantly as the baseline score increased (for total NIH-CPSI p <0.01). Tamsulosin efficacy was superior to placebo at the 75th percentile of baseline score for the total NIH-CPSI score (-8.3, p <0.01), the pain domain (-2.9, p = 0.02), the urinary symptoms domain (-2.3, p <0.01) and the impact/quality of life domain (-2.1, p = 0.02). The efficacy of tamsulosin increased with time (no significant treatment difference at 15 days) and tamsulosin was well tolerated.
CONCLUSIONS: Tamsulosin was superior to placebo in providing symptomatic relief in men with CP/CPPS, particularly in those with more severe symptoms.