Vestibulectomy Surgical Techniques Comparison Study

Oregon Health & Science University (OHSU)

Status: Enrolling

Conditions: Vulvar Pain; Vulvodynia

Treatments: Other: Traditional Technique; Other: Modified Technique

Study type: Interventional

Funder types: Other

Identifiers

NCT05343182

OHSU IRB 24107

Details and patient eligibility

About

Vestibulectomy Surgical Techniques Comparison Study

Full description

Vestibulectomy: A Prospective Comparison of Two Surgical Techniques for the treatment of Provoked Localized Vulvodynia (PVD)

Enrollment: 118 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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118 participants in 2 patient groups

Modified Vestibulectomy

Active Comparator group

Treatment:

Other: Modified Technique

Traditional Vestibulectomy

Active Comparator group

Treatment:

Other: Traditional Technique