Cited by 83Sexual function and dysfunction studiesPelvic floor disorders treatmentsUrinary Bladder and Prostate Research

The Tampon Test for Vulvodynia Treatment Outcomes Research: Reliability, Construct Validity, and Responsiveness

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Foster, David C., Beth Kotok, Merrill, Huang, Li-Shan, Watts, Arthur, Oakes, David, Howard, Fred M., Stodgell, Chris J., Dworkin, Robert H.·2009·Obstetrics & Gynecology

Abstract

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%). CONCLUSION: 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. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00276068 LEVEL OF EVIDENCE: II.

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  1. [13]Foster DC Duguid KM Open label study of oral destipamine and topical lidocaine for the treatment of vulvar vestibulitis Abstract, Int. Conf. on Mechanism and Treatment of Neuropathic Pain 1998 Rochester, NY

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Authors
Foster, D. C., Beth Kotok, M., Huang, L.-S., Watts, A., Oakes, D., Howard, F. M., Stodgell, C. J., & Dworkin, R. H.
Affiliations
University of Rochester Medicine (US)
Venue
Obstetrics & Gynecology
Published
2009-04
Volume
113
Issue
4
Pages
825-832
ISSN
0029-7844 (ISSN-L)
OpenAlex
W1990089420
Cited by
83
References
20
Citations by year
2026: 4 · 2025: 4 · 2024: 5 · 2023: 5 · 2022: 5 · 2021: 5 · 2020: 4 · 2019: 8 · 2018: 5 · 2017: 5 · 2016: 6 · 2015: 6 · 2014: 4 · 2013: 4 · 2012: 6
FWCI
2.67
Type
journal article
Language
en
Open access
Locations
  • Obstetrics and Gynecology (publishedVersion)
  • PubMed (publishedVersion)
  • PubMed Central (acceptedVersion)
Funders
Eunice Kennedy Shriver National Institute of Child Health and Human Development (R0-1 HD040123-05, R01HD040123)
Topics
  • Health Sciences › Medicine › Psychiatry and Mental health › Sexual function and dysfunction studies
  • Health Sciences › Medicine › Rheumatology › Pelvic floor disorders treatments
  • Health Sciences › Medicine › Urology › Urinary Bladder and Prostate Research
Keywords
vulvodynia, outcome measures, test-retest reliability, construct validity, responsiveness to change, desipramine, lidocaine, vulvar vestibulitis, patient adherence, clinical trial endpoints
MeSH terms
Adult, Anesthetics, Local, Coitus, Desipramine, Diagnostic Techniques, Obstetrical and Gynecological, Double-Blind Method, Drug Combinations, Drug Synergism, Female, Humans, Lidocaine, Pain, Pain Measurement, Sensitivity and Specificity, Vulvar Diseases, Reproducibility of Results, Treatment Outcome, Adrenergic Uptake Inhibitors

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