title: Optical coherence tomography compared with colposcopy for assessment of vaginal epithelial damage: a randomized controlled trial.
abstract: OBJECTIVE
  Colposcopy has been used to detect epithelial damage with vaginal microbicides. In animal models, optical coherence tomography provided increased sensitivity over colposcopy in detecting epithelial injury. This randomized, double-blinded, clinical study compared optical coherence tomography to colposcopy for the evaluation of epithelial injury in women using placebo or nonoxynol-9.
  
  
  METHODS
  Thirty women aged 18-45 were randomized to use hydroxyethyl cellulose placebo or nonoxynol-9 vaginal gel twice daily for 5.5 days. Imaging with colposcopy and optical coherence tomography was performed before product use, after the last dose, and 1 week later. Colposcopy was graded using standard criteria. Optical coherence tomography images were scored for epithelial integrity based on a published scoring system and were measured for epithelial thickness.
  
  
  RESULTS
  Colposcopy findings, optical coherence tomography scores, and epithelial thicknesses were similar between treatment groups at baseline. After treatment, there were significant differences between the nonoxynol-9 (1.37) and control group (1.15) optical coherence tomography scores (P<.001), indicating epithelial injury, and there was epithelial thinning in the nonoxynol-9 group (237 micrometers) compared with the control group (292 micrometers; P=.008). There were no significant posttreatment colposcopic differences in epithelial disruption between treatment groups, with only increased erythema noted after nonoxynol-9 use (P=.02).
  
  
  CONCLUSIONS
  Optical coherence tomography detected epithelial disruption and thinning not identified by colposcopy. Vaginal epithelial thickness, a measure previously available only through biopsy, decreased after nonoxynol-9 use, a finding that may contribute to increased susceptibility to human immunodeficiency virus after frequent use. Optical coherence tomography shows promise for the noninvasive clinical assessment of vaginal epithelial damage.
  
  
  BACKGROUND
  UMIN Clinical Trials Registry, www.umin.ac.jp/ctr/index.htm, R000006186.
  
  
  METHODS
  I.
authors: From the University of Texas Medical Branch, Galveston, Texas; Columbia University Medical Center, College of Physicians and Surgeons, and New York Presbyterian Morgan Stanley Children's Hospital, New York, New York; ReProtect, Inc, Baltimore, Maryland; the College of Medicine, Mayo Clinic, Rochester, Minnesota; the University of Connecticut Health Center, Farmington, Connecticut; and Starpharma, Melbourne, Australia.
authors: Kathleen L
authors: KL
authors: Vincent
authors: Lawrence R
authors: LR
authors: Stanberry
authors: Thomas R
authors: TR
authors: Moench
authors: Carmen Radecki
authors: CR
authors: Breitkopf
authors: Melissa L
authors: ML
authors: Loza
authors: Jingna
authors: J
authors: Wei
authors: James
authors: J
authors: Grady
authors: Jeremy
authors: J
authors: Paull
authors: Massoud
authors: M
authors: Motamedi
authors: Susan L
authors: SL
authors: Rosenthal
mesh_terms: D000328:Adult; D003127:Colposcopy; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D017137:Nonoxynol / Q000009:adverse effects*; D013089:Spermatocidal Agents / Q000009:adverse effects*; D041623:Tomography, Optical Coherence; D014623:Vaginal Diseases / Q000139:chemically induced / Q000175:diagnosis*; D055815:Young Adult
chemical_list: D013089:Spermatocidal Agents; D017137:Nonoxynol