Evidence map›Paper›PMID 22105265›Full record

Trial reportObstetrics and gynecology2011

Optical coherence tomography compared with colposcopy for assessment of vaginal epithelial damage: a randomized controlled trial.

Kathleen L Vincent, Lawrence R Stanberry, Thomas R Moench, Carmen Radecki Breitkopf, Melissa L Loza, Jingna Wei, James Grady, Jeremy Paull, Massoud Motamedi, Susan L Rosenthal

Abstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Obstetrics and gynecology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
1.3field-weighted citation impact, top 22% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 19 citations in OpenAlex.

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  7. Optical Vaginal Biopsy Using Optical Coherence Tomography.Female pelvic medicine & reconstructive surgery · 2020
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 1 institution in 1 country.

Kathleen L VincentFrom 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.
Lawrence R Stanberry
Thomas R Moench
Carmen Radecki Breitkopf
Melissa L Loza
Jingna Wei
James Grady
Jeremy Paull
Massoud Motamedi
Susan L Rosenthal
NewYork–Presbyterian Hospital · US

Funding

UTMB CLINICAL AND TRANSLATIONAL SCIENCE AWARD: NASA BED REST STUDIESUL1RR029876 · NCRR · UNIVERSITY OF TEXAS MED BR GALVESTON · PI BRASIER, ALLAN R. · 2009 to 2011
$17.7M
UTMB Clinical and Translational Science AwardUL1TR000071 · NCATS · UNIVERSITY OF TEXAS MED BR GALVESTON · PI BRASIER, ALLAN R. · 2012 to 2014
$14.4M
Supplement to grant: Development of Dendrimer and Combination MicrobicidesU19AI060598 · NIAID · STARPHARMA, LTD · PI PAULL, JEREMY · 2004 to 2009
$6.9M
NCATS NIH HHS UL1 TR000071NCRR NIH HHS 1UL1RR029876-01NCRR NIH HHS UL1 RR029876NIAID NIH HHS U19 AI060598
6 · The paper itself

Abstract

objectiveColposcopy 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.

methodsThirty 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.

resultsColposcopy 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).

conclusionOptical 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. CLINICAL

trial registrationUMIN Clinical Trials Registry, www.umin.ac.jp/ctr/index.htm, R000006186. LEVEL OF EVIDENCE: I.

Indexed as

ColposcopyTomography, Optical CoherenceAdultDouble-Blind MethodFemaleHumansNonoxynolSpermatocidal AgentsVaginal DiseasesYoung AdultNonoxynolSpermatocidal Agents

Identifiers

PMID22105265
PMCPMC3245981
OpenAlexW2025824734

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.