title: Pain and morbidity of transrectal ultrasound guided prostate biopsy: a prospective randomized trial of 6 versus 12 cores.
abstract: OBJECTIVE
  An increasing number of studies suggest that 6-sector transrectal ultrasound guided biopsy of the prostate provides insufficient material to detect all clinically important prostate cancers and more cores may improve detection rates. We performed a prospective, randomized study to determine the effect of increasing the number of cores from 6 to 12 on pain and other morbidity associated with the biopsy procedure.
  
  
  METHODS
  A total of 160 men (44 black, 28%) with a mean age plus or minus standard deviation of 65+/-8 years who had serum prostate specific antigen between 2.5 and 20.0 ng./ml. and/or digital rectal examination findings suspicious for cancer were prospectively randomized to undergo 6 or 12-core biopsy. Patients completed a self-administered questionnaire addressing pain and other morbidity before, and immediately and 2 and 4 weeks after biopsy.
  
  
  RESULTS
  There was no difference between groups in mean pain scale with time for abdominal and rectal pain. For probe insertion, needle insertion and overall pain there was a significant increase in pain recalled at 2 which persisted at 4 weeks compared to immediately after biopsy. However, there was no difference for these 3 post-biopsy pain measures between the 6 and 12-core groups. In the 12-core group there was a statistically significant increase in hematochezia and hematospermia (24% versus 10%, p = 0.04 and 89% versus 71%, p = 0.01, respectively) but no significant difference between groups reporting morbidity as a moderate or major problem. There was no significant change in International Prostate Symptom Score, fever or hospitalization in the 12-core group.
  
  
  CONCLUSIONS
  The 12-core prostate biopsy procedure is generally well tolerated and can be safely performed with no significant difference in pain or morbidity compared to the 6-core procedure.
authors.affiliation: Department of Surgery, Washington University School of Medicine, St. Louis, Missouri 63110, USA.
authors.forename: C K
authors.initials: CK
authors.lastname: Naughton
authors.forename: D K
authors.initials: DK
authors.lastname: Ornstein
authors.forename: D S
authors.initials: DS
authors.lastname: Smith
authors.forename: W J
authors.initials: WJ
authors.lastname: Catalona
mesh_terms: D000368:Aged; D001707:Biopsy, Needle / Q000009:adverse effects* / Q000379:methods / Q000706:statistics & numerical data*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010149:Postoperative Pain / Q000453:epidemiology / Q000209:etiology; D011183:Postoperative Complications / Q000453:epidemiology / Q000209:etiology; D011446:Prospective Studies; D011471:Prostatic Neoplasms / Q000000981:diagnostic imaging / Q000473:pathology*; D012007:Rectum; D011795:Surveys and Questionnaires; D014463:Ultrasonography