Vestibulectomy Surgical Techniques Comparison Study

Launched by OREGON HEALTH AND SCIENCE UNIVERSITY · Apr 18, 2022

Keywords

ClinConnect Summary

The Vestibulectomy Surgical Techniques Comparison Study is looking to understand the different surgical methods used to treat vulvar pain, specifically a condition called vulvodynia. This trial is currently recruiting female participants aged 18 and older who have been experiencing discomfort in the vaginal area for at least three months. To qualify, participants must have a certain level of sensitivity in the vestibule (the area around the vaginal opening) and should be willing to engage in pelvic floor physical therapy. It's important that they do not have other medical conditions that could cause similar pain, such as endometriosis or skin issues.

If you or someone you know might be eligible, participants can expect to undergo assessments to determine their pain levels and receive treatment through one of the surgical techniques being studied. They will also need to have access to a phone and the internet since these may be necessary for communication throughout the trial. This study hopes to improve how vulvodynia is treated and help women find relief from their symptoms.

Gender

FEMALE

Eligibility criteria

• 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