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Title of Journal: Arch Gynecol Obstet

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Abbravation: Archives of Gynecology and Obstetrics

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Springer-Verlag

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DOI

10.1002/cne.901640109

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1432-0711

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Assessing menstrual tampon irritation using the “B

Authors: Miranda A Farage Kenneth W Miller William J Ledger
Publish Date: 2012/11/24
Volume: 287, Issue: 3, Pages: 435-439
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Abstract

Colposcopic inspection of the vagina is a routine component of the safety assessment of intravaginal products However colposcopic findings occur frequently in healthy women raising questions about their relevance to intravaginal product safety Practical disadvantages limit the utility of colposcopy for evaluating menstrual tampons among them the presence of background microtrauma the inability to assess effects during menstruation and importantly the question of whether post hoc assessments are sufficiently sensitive to detect small inflammatory changes The BehindTheKnee BTK test is an alternative for evaluating inflammatory and tissue dryness effects of physical articles by their repeated application to the popliteal fossa under an elastic bandage It enables concurrent parallel comparisons of experimental and control articles over time and substantially increases the sensitivity of detecting small changes in tissue inflammationWith the protocol uncompressed experimental and control tampons yielded comparable relative and absolute erythema scores after overnight recovery as did colposcopic assessment of the lower genital tract 3–48 h after menstrual use Scoring erythema in the BTK test immediately after product removal increased the level of visually discernible inflammation sixfold In a study of commercial menstrual pads subclinical inflammation visualized with crosspolarized light correlated with the frequency of subjective reports of discomfort during the test and discriminated the relative tolerability of the two products determined by market surveillance providing added confidence in the predictive value of the testWith kind permission from Open Journal of Obstetrics and Gynecology OJOG ISSN 21608806 Scientific Research Publishing SCIRP Farage Miller Ledger 2012 The “BehindTheKnee” test for menstrual tampon irritation Open Journal of Obstetrics and Gynecology 2012 2 34–38

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