Vestibulectomy Surgical Techniques Comparison Study
Vestibulectomy: A Prospective Comparison of Two Surgical Techniques for the Treatment of Provoked Localized Vulvodynia (PVD)
Oregon Health and Science University
118 participants
Oct 6, 2022
INTERVENTIONAL
Conditions
Summary
Vestibulectomy Surgical Techniques Comparison Study
Eligibility
Inclusion Criteria5
- 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 Criteria5
- 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
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Interventions
This operation is performed using modified anesthesia care/deep sedation (MAC) for anesthesia. The vestibule is removed to the boundary of Harts line. The surgical flap for this procedure is the Hymen plus 1 cm of the vagina.
This operation is performed using an Laryngeal Mask Airway (LAM), (modified anesthesia care/deep sedation) for anesthesia. The vestibule is removed 0.5 to 1 cm beyond the boundary of the Hart's line. The Hymen plus 1 cm of the vagina is excised.
Locations(1)
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NCT05343182