title: Design of a multicenter randomized clinical trial for chronic prostatitis/chronic pelvic pain syndrome.
abstract: OBJECTIVE
  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.affiliation: Department of Biostatistics and Epidemiology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania 19104-6021, USA.
authors.forename: Kathleen J
authors.initials: KJ
authors.lastname: Propert
authors.forename: Richard B
authors.initials: RB
authors.lastname: Alexander
authors.forename: J Curtis
authors.initials: JC
authors.lastname: Nickel
authors.forename: John W
authors.initials: JW
authors.lastname: Kusek
authors.forename: Mark S
authors.initials: MS
authors.lastname: Litwin
authors.forename: J Richard
authors.initials: JR
authors.lastname: Landis
authors.forename: Leroy M
authors.initials: LM
authors.lastname: Nyberg
authors.forename: Anthony J
authors.initials: AJ
authors.lastname: Schaeffer
mesh_terms: D000317:Adrenergic alpha-Antagonists / Q000627:therapeutic use; D000890:Anti-Infective Agents / Q000627:therapeutic use; D002908:Chronic Disease; D002939:Ciprofloxacin / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D006801:Humans; D008297:Male; D015337:Multicenter Studies as Topic / Q000379:methods*; D017699:Pelvic Pain / Q000188:drug therapy*; D011472:Prostatitis / Q000188:drug therapy*; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012107:Research Design; D013449:Sulfonamides / Q000627:therapeutic use; D000077409:Tamsulosin
chemical_list: D000317:Adrenergic alpha-Antagonists; D000890:Anti-Infective Agents; D013449:Sulfonamides; D002939:Ciprofloxacin; D000077409:Tamsulosin