Status:
RECRUITING
Vestibulectomy Surgical Techniques Comparison Study
Lead Sponsor:
Oregon Health and Science University
Conditions:
Vulvar Pain
Vulvodynia
Eligibility:
FEMALE
18-80 years
Phase:
NA
Brief 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
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
October 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT05343182
Start Date
October 6 2022
End Date
June 1 2027
Last Update
September 19 2024
Active Locations (1)
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1
Oregon Health and Science University
Portland, Oregon, United States, 97239