TY - JOUR
T1 - Design of a multicenter randomized clinical trial for chronic prostatitis/chronic pelvic pain syndrome1
AU - Propert, Kathleen J.
AU - Alexander, Richard B.
AU - Nickel, J. Curtis
AU - Kusek, John W.
AU - Litwin, Mark S.
AU - Landis, J. Richard
AU - Nyberg, Leroy M.
AU - Schaeffer, Anthony J.
N1 - Funding Information:
This study was supported by grants R01 DK53736, R01 DK53752, R01 DK53732, R01 DK53730, R01 DK53734, and R01 DK53746 from the National Institute of Diabetes, Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland.
PY - 2002
Y1 - 2002
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=0036098076&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0036098076&partnerID=8YFLogxK
U2 - 10.1016/S0090-4295(02)01601-1
DO - 10.1016/S0090-4295(02)01601-1
M3 - Article
C2 - 12031372
AN - SCOPUS:0036098076
SN - 0090-4295
VL - 59
SP - 870
EP - 876
JO - Urology
JF - Urology
IS - 6
ER -