Phase
Condition
N/ATreatment
Traditional Technique
Modified Technique
Clinical Study ID
Ages 18-80 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Reported provoked tenderness to the vestibule for at least 3 months in non-pregnant,estrogen-replete healthy subjects aged 18 years or over meeting Friedrich's criteriafor PVD44-45 and supported by the ISSVD Terminology Consensus Definition45 forvulvar pain. Subjects who are >45years of age must have either have a maturationindex52 of < 10% parabasal cells or willingness to participate in local estrogenreplacement until achieving this same clinical result.
Cotton swab Test30-31 mean verbal rating score of ≥4/10 in 4 of 6 defined points ofthe vestibule (2, 4, 6, 8, 10, 12 o'clock) and cotton swab test verbal score ≤ 2/10for the labia majora and minora, intra labial sulcus, and perineum
Ability to insert a regular Tampax® tampon
Baseline Tampon Test verbal pain score ≥430
f. Phone and internet access e. Willingness to engage in pelvic floor physical therapy (PT)
Exclusion
Exclusion Criteria:
Pregnancy
Any other clinical reason for dyspareunia (endometriosis pain, chronic pelvic pain,vulvar dermatoses such as psoriasis, lichen sclerosus)
Unable or unwilling to complete baseline assessments
Prior vestibulectomy or hymen surgery
Prior or current use of testosterone dosed for gender affirmation
Study Design
Study Description
Connect with a study center
Oregon Health and Science University
Portland, Oregon 97239
United StatesActive - Recruiting
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