The Tampon Test for Vulvodynia Treatment Outcomes Research: Reliability, Construct Validity, and Responsiveness
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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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The tampon test has fair to moderate week-to-week test-retest reliability.
“The tampon test has a fair to moderate week-to-week test-retest reliability and is significantly associated with pain at intercourse and pain intensity (Foster et al., 2009).”
From Internet-based treatment for vulvodynia (EMBLA) – Study protocol for a randomised controlled study (2021) · cites this paper as Foster et al., 2009
The tampon test is significantly associated with pain at intercourse and pain intensity.
“The tampon test has a fair to moderate week-to-week test-retest reliability and is significantly associated with pain at intercourse and pain intensity (Foster et al., 2009).”
From Internet-based treatment for vulvodynia (EMBLA) – Study protocol for a randomised controlled study (2021) · cites this paper as Foster et al., 2009
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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)
- PMC
- PMC2756618
- 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
- green
- www.ncbi.nlm.nih.gov
- 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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