OBJECTIVES: To describe the study design and rationale for the first placebo-controlled, randomized clinical trial to be conducted by the Chronic Prostatitis Collaborative Research Network sponsored by the National Institutes of Health. METHODS: The clinical trial will use a 2 by 2 factorial design to evaluate four treatments: placebo, tamsulosin hydrochloride alone, ciprofloxacin alone, and tamsulosin hydrochloride and ciprofloxacin combined. The primary objectives are to compare the efficacy and safety endpoints in patients with chronic prostatitis/chronic pelvic pain syndrome. The study population consists of men with symptoms of discomfort or pain in the pelvic region for at least a 3-month period. One hundred eighty-four participants will be treated for 6 weeks and followed up for an additional 6 weeks. The primary endpoint is the change in the overall National Institutes of Health Chronic Prostatitis Symptom Index from baseline to 6 weeks. Secondary endpoints include a patient-reported global assessment of response and white blood cell counts and cultures in urine, expressed prostatic secretions, and semen. The evaluation of changes from 6 to 12 weeks will be used to assess the durability of the response. RESULTS: This trial was opened to enrollment in July 2001. The study is expected to require 14 months of accrual and follow-up. CONCLUSIONS: The issues considered in the design of this clinical trial may provide guidelines for future clinical trials in chronic prostatitis/chronic pelvic pain syndrome.
RCT Entities:
OBJECTIVES: To describe the study design and rationale for the first placebo-controlled, randomized clinical trial to be conducted by the Chronic Prostatitis Collaborative Research Network sponsored by the National Institutes of Health. METHODS: The clinical trial will use a 2 by 2 factorial design to evaluate four treatments: placebo, tamsulosin hydrochloride alone, ciprofloxacin alone, and tamsulosin hydrochloride and ciprofloxacin combined. The primary objectives are to compare the efficacy and safety endpoints in patients with chronic prostatitis/chronic pelvic pain syndrome. The study population consists of men with symptoms of discomfort or pain in the pelvic region for at least a 3-month period. One hundred eighty-four participants will be treated for 6 weeks and followed up for an additional 6 weeks. The primary endpoint is the change in the overall National Institutes of Health Chronic Prostatitis Symptom Index from baseline to 6 weeks. Secondary endpoints include a patient-reported global assessment of response and white blood cell counts and cultures in urine, expressed prostatic secretions, and semen. The evaluation of changes from 6 to 12 weeks will be used to assess the durability of the response. RESULTS: This trial was opened to enrollment in July 2001. The study is expected to require 14 months of accrual and follow-up. CONCLUSIONS: The issues considered in the design of this clinical trial may provide guidelines for future clinical trials in chronic prostatitis/chronic pelvic pain syndrome.
Authors: Michel A Pontari; John N Krieger; Mark S Litwin; Paige C White; Rodney U Anderson; Mary McNaughton-Collins; J Curtis Nickel; Daniel A Shoskes; Richard B Alexander; Michael O'Leary; Scott Zeitlin; Shannon Chuai; J Richard Landis; Liyi Cen; Kathleen J Propert; John W Kusek; Leroy M Nyberg; Anthony J Schaeffer Journal: Arch Intern Med Date: 2010-09-27
Authors: J Curtis Nickel; Richard B Alexander; Rodney Anderson; Richard Berger; Craig V Comiter; Nand S Datta; Jackson E Fowler; John N Krieger; J Richard Landis; Mark S Litwin; Mary McNaughton-Collins; Michael P O'Leary; Michel A Pontari; Anthony J Schaeffer; Daniel A Shoskes; Paige White; John Kusek; Leroy Nyberg Journal: Curr Urol Rep Date: 2008-07 Impact factor: 3.092
Authors: J Curtis Nickel; John N Krieger; Mary McNaughton-Collins; Rodney U Anderson; Michel Pontari; Daniel A Shoskes; Mark S Litwin; Richard B Alexander; Paige C White; Richard Berger; Robert Nadler; Michael O'Leary; Men Long Liong; Scott Zeitlin; Shannon Chuai; J Richard Landis; John W Kusek; Leroy M Nyberg; Anthony J Schaeffer Journal: N Engl J Med Date: 2008-12-18 Impact factor: 91.245
Authors: K J Propert; M S Litwin; Y Wang; R B Alexander; E Calhoun; J C Nickel; M P O'Leary; M Pontari; M McNaughton-Collins Journal: Qual Life Res Date: 2006-03 Impact factor: 4.147