RecruitingNot Applicable

Vestibulectomy Surgical Techniques Comparison Study

United States118 participantsStarted 2022-10-06

Plain-language summary

Age range18 Years – 80 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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 criteria for PVD44-45 and supported by the ISSVD Terminology Consensus Definition45 for vulvar pain. Subjects who are \>45years of age must have either have a maturation index52 of \< 10% parabasal cells or willingness to participate in local estrogen replacement until achieving this same clinical result.
✓. Cotton swab Test30-31 mean verbal rating score of ≥4/10 in 4 of 6 defined points of the vestibule (2, 4, 6, 8, 10, 12 o'clock) and cotton swab test verbal score ≤ 2/10 for the labia majora and minora, intra labial sulcus, and perineum
✓. Ability to insert a regular Tampax® tampon
✓. Baseline Tampon Test verbal pain score ≥430

✕. 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

Change in Tampon Test pain scores from baseline to 3 months

Timeframe: Baseline visit to 3 months after surgery

Change in pain scores from baseline to 6 months

Timeframe: Baseline visit to 6 months after surgery

Change in pain scores from baseline to 12 months

Timeframe: Baseline visit to 12 months after surgery

NCT IDNCT05343182

SponsorOregon Health and Science University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06

Women's Health Research Unit Confidential Recruitment Line

Who can participate