title: Recruitment of participants to a clinical trial of botanical therapy for benign prostatic hyperplasia.
abstract: OBJECTIVE
  The timely recruitment of study participants is a critical component of successful trials. Benign prostatic hyperplasia (BPH), a common nonmalignant urologic condition among older men, is characterized by lower urinary tract symptoms (LUTS). Successful recruitment methods for a trial of medical therapy for BPH, Medical Therapy of Prostate Symptoms (MTOPS), were mass mailing and advertising. The Complementary and Alternative Medicines Trial for Urological Symptoms (CAMUS) was designed to evaluate a botanical therapy, saw palmetto, for the treatment of BPH. The objective of this study was to evaluate recruitment strategies for CAMUS and to contrast the baseline characteristics of CAMUS participants with those recruited to a similar trial using conventional medical therapy.
  
  
  METHODS
  CAMUS is a randomized, double-blind, placebo-controlled trial designed to evaluate the effects of saw palmetto given at escalating doses over an 18-month period on relief from LUTS.
  
  
  METHODS
  The target enrollment goal was 350 men with LUTS from 11 clinical centers over a 12-month period. The recruitment techniques used and participants contacted, screened, and randomized through each technique were obtained from the clinical centers. Baseline characteristics of the CAMUS participants were compared with participants in the MTOPS trial who met the CAMUS eligibility criteria for LUTS.
  
  
  RESULTS
  The target enrollment goal was achieved in 11 months. The overall monthly recruitment rate per site was 3.7 and ranged from 2.4 to 8.0. The most successful recruitment methods were mass mailing and advertising, which accounted for 39% and 35% of the study participants, respectively. In comparison to MTOPS participants, CAMUS participants were younger, more highly educated, more diverse, and had less severe urinary symptoms.
  
  
  CONCLUSIONS
  Successful recruitment methods for CAMUS were similar to those in MTOPS. The use of botanical therapy attracted a less symptomatic and more educated study population.
authors.affiliation: Department of Biostatistics, University of Arkansas for Medical Sciences, 4301 West Markham, Little Rock, AR 72205, USA. jylee@uams.edu
authors.forename: Jeannette Y
authors.initials: JY
authors.lastname: Lee
authors.forename: Harris E
authors.initials: HE
authors.lastname: Foster
authors.forename: Kevin T
authors.initials: KT
authors.lastname: McVary
authors.forename: Sreelatha
authors.initials: S
authors.lastname: Meleth
authors.forename: Karen
authors.initials: K
authors.lastname: Stavris
authors.forename: Joe
authors.initials: J
authors.lastname: Downey
authors.forename: John W
authors.initials: JW
authors.lastname: Kusek
mesh_terms: D000329:Advertising; D000368:Aged; D006801:Humans; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D008517:Phytotherapy; D010936:Plant Extracts / Q000627:therapeutic use*; D011470:Prostatic Hyperplasia / Q000150:complications / Q000188:drug therapy*; D012107:Research Design; D028024:Serenoa; D012923:Social Class; D014570:Urologic Diseases / Q000188:drug therapy* / Q000209:etiology
chemical_list: D010936:Plant Extracts