NCT05343182NARecruiting
Vestibulectomy Surgical Techniques Comparison Study
Oregon Health and Science University
Start Date
10/6/2022
Completion Date
6/1/2027
Summary
Vestibulectomy Surgical Techniques Comparison Study
Detailed Description
Vestibulectomy: A Prospective Comparison of Two Surgical Techniques for the treatment of Provoked Localized Vulvodynia (PVD)
Eligibility Criteria
Age Range: 18 years to 80 years
Inclusion Criteria:
1. 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.
2. 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
3. Ability to insert a regular Tampax® tampon
4. Baseline Tampon Test verbal pain score ≥430
f. Phone and internet access e. Willingness to engage in pelvic floor physical therapy (PT)
Exclusion Criteria:
1. Pregnancy
2. Any other clinical reason for dyspareunia (endometriosis pain, chronic pelvic pain, vulvar dermatoses such as psoriasis, lichen sclerosus)
3. Unable or unwilling to complete baseline assessments
4. Prior vestibulectomy or hymen surgery
5. Prior or current use of testosterone dosed for gender affirmation
Interventions
OTHER
Modified Technique
OTHER
Traditional Technique
Conditions
Vulvar PainVulvodynia
Locations
Oregon Health and Science University
Portland, Oregon 97239
United States