Vulvar Vestibulitis
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Data from D.C. Foster and colleagues advance knowledge in obstetrics
2009 MAY 11 - (NewsRx.com) -- "A standardized tampon insertion and removal test, the Tampon Test provides an alternative to sexual intercourse pain as an outcome measure for vulvodynia research. We report upon the reliability, validity, and responsiveness to change of the Tampon Test as an outcome measure for vulvodynia clinical trials," scientists in the United States report. "Outcome measures were assessed in women enrolled in the Vulvar Vestibulitis Clinical Trial, a randomized clinical trial of oral desipramine and topical lidocaine effectiveness. Reliability estimates of the Tampon Test using the Kappa statistic evaluated week-to-week measures at baseline. Tampon Test construct and discriminant validity were assessed through correlation with other outcome measures. Patients' ability to regularly perform the Tampon Test was compared with regularity of reporting intercourse pain. During the 2-week baseline phase, women with vulvodynia reported stable mean Tampon Test scores 4.6 +/- 2.6 (week -2); 4.6 +/- 2.7 (week -1); and 4.7 +/- 2.8 (week 0) with moderate week-to-week reliability (weighted Kappa 0.52). Over an 8-week phase of trial intervention, change in the Tampon Test measure significantly correlated to a number of outcome measures, including daily pain (r=0.42), intercourse pain (r=0.35), cotton swab vestibular pain (r=0.38), and the Brief Pain Inventory (r=0.49). Women with vulvodynia study participants performed the Tampon Test 96.3% of the requested time, which was twofold higher adherence than intercourse pain measurement (49.7%). The Tampon Test reflects a real life experience that is reliable, with good construct validity as shown by the breadth of correlated outcome measures," wrote D.C. Foster and colleagues. The researchers concluded: "The Tampon Test is an appropriate outcome measure for vulvodynia research that can be considered for use as the primary efficacy endpoint in clinical trials of treatments for vulvodynia." Foster and colleagues published their study in Obstetrics and Gynecology (The Tampon Test for Vulvodynia Treatment Outcomes Research Reliability, Construct Validity, and Responsiveness. Obstetrics and Gynecology, 2009;113(4):825-832). For additional information, contact D.C. Foster, Strong Mem Hospital, 601 Elmwood Avenue, Rochester, NY 14642, USA. The publisher's contact information for the journal Obstetrics and Gynecology is: Lippincott Williams & Wilkins, 530 Walnut St., Philadelphia, PA 19106-3621, USA. Keywords: United States, Rochester, Antidepressant, Clinical Trial Research, Desipramine, Drugs, Gynecology, Lidocaine, Norepinephrine-Reuptake Inhibitor, Obstetrics, Pharmaceuticals, Therapy, Treatment. This article was prepared by Biotech Business Week editors from staff and other reports. Copyright 2009, Biotech Business Week via NewsRx.com.
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