Vestibulectomy Surgical Techniques Comparison Study
Recruiting now · Not applicable
Conditions studied: Vulvar Pain, Vulvodynia
In brief
Vestibulectomy Surgical Techniques Comparison Study
Key facts
- Study ID
- NCT05343182
- Run by
- Oregon Health and Science University
- People needed
- 118
- Starts
- 2022-10-06
- Expected to finish
- 2027-06-01
- Last updated by the study team
- 2024-09-19
Who can join
Age: 18 and older, up to 80. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
- f. Phone and internet access e. Willingness to engage in pelvic floor physical therapy (PT)
You may not qualify if…
- 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
Where it is running
- Oregon Health and Science University — Portland, Oregon, United States (enrolling)
Full record on ClinicalTrials.gov
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