Back to Trials
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

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Vulvar PainVulvodynia

Locations

Oregon Health and Science University

Portland, Oregon 97239

United States