CompletedNot Applicable

The Reciprocal Relations Between Psychosocial Characteristics and the Progression of Vestibulodynia

Israel113 participantsStarted 2016-11-30

Plain-language summary

The proposed study will evaluate how personality characteristics, cognitive factors and the emotional and behavioral responses of patients with provoked vestibulodynia (localized provoked vulvodynia) influence the natural history of the syndrome, patients' adherence to therapeutic interventions, provoked pain levels, pelvic floor rehabilitation, emotional health and sexual functioning.

Who can participate

Age range18 Years – 45 Years

SexFEMALE

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Inclusion criteria

✓. A history of 3 months or more of vulvar pain suggestive of PVD, i.e. symptoms of pain on vaginal penetration (insertional dyspareunia and/or pain with tampon insertion).
✓. On exam, tenderness localized within the vestibule when being touched with a cotton-tip applicator.
✓. No identifiable cause for the pain, such as vulvovaginal candidiasis, vaginal atrophy, desquamative inflammatory vaginitis (DIV), herpes, dermatitis or vulvar dystrophy.

Exclusion criteria

✕. other causes for vulvar pain
✕. pregnancy or a planned pregnancy in the upcoming year
✕. diagnosis of chronic disease that may affect central nervous system or general function.
✕. usage of psychiatric medications or those affecting pain modulation.
✕. unprovoked or mixed vulvodynia

What they're measuring

Change of measure of Q tip test assessing pain intensity

Timeframe: Change in measure between recruitment to 3 months, 6 months , 9 months and 12 months

Trial details

NCT IDNCT02892214

SponsorMeir Medical Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-12

View on ClinicalTrials.gov More Localized Provoked Vulvodynia trials