The tampon test for vulvodynia treatment outcomes research: reliability, construct validity, and responsiveness.
OBJECTIVE
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.


METHODS
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.


RESULTS
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%).


CONCLUSIONS
The Tampon Test reflects a real life experience that is reliable, with good construct validity as shown by the breadth of correlated outcome measures. 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.


BACKGROUND
ClinicalTrials.gov, www.clinicaltrials.gov, NCT00276068


METHODS
II.
Foster
David C
DC
From the Departments of Obstetrics and Gynecology, Biostatistics, and Anesthesiology, University of Rochester School of Medicine and Dentistry, Rochester, New York.
Beth Kotok
Merrill
M
Huang
Li-Shan
LS
Watts
Arthur
A
Oakes
David
D
Howard
Fred M
FM
Stodgell
Chris J
CJ
Dworkin
Robert H
RH
D018759:Adrenergic Uptake Inhibitors; D000328:Adult; D000779:Anesthetics, Local; D003075:Coitus / Q000502:physiology / Q000523:psychology; D003891:Desipramine / Q000627:therapeutic use*; D003944:Diagnostic Techniques, Obstetrical and Gynecological / Q000592:standards*; D004311:Double-Blind Method; D004338:Drug Combinations; D004357:Drug Synergism; D005260:Female; D006801:Humans; D008012:Lidocaine / Q000627:therapeutic use*; D010146:Pain / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology; D010147:Pain Measurement / Q000379:methods* / Q000592:standards; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D016896:Treatment Outcome; D014845:Vulvar Diseases / Q000175:diagnosis / Q000188:drug therapy* / Q000473:pathology
D018759:Adrenergic Uptake Inhibitors; D000779:Anesthetics, Local; D004338:Drug Combinations; D008012:Lidocaine; D003891:Desipramine