RecruitingNot Applicable

Vestibulectomy Surgical Techniques Comparison Study

United States118 participantsStarted 2022-10-06

Plain-language summary

Who can participate

Age range

18 Years – 80 Years

Sex

FEMALE

See this in plain English?

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

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 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

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Trial details

NCT IDNCT05343182

SponsorOregon Health and Science University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06

Contact for this trial

Women's Health Research Unit Confidential Recruitment Line

503-494-3666 whru@ohsu.edu

View on ClinicalTrials.gov More Vulvar Pain trials