Comparison of two surgical techniques for vulvar pain treatment
Vestibulectomy: A Prospective Comparison of Two Surgical Techniques for the Treatment of Provoked Localized Vulvodynia (PVD)
This study is testing which of two surgical methods works better to relieve vulvar pain for people with provoked localized vulvodynia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 118 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Female |
| Sponsor | Oregon Health and Science University Academic / other |
| Locations | 1 site (Portland, Oregon) |
| Trial ID | NCT05343182 on ClinicalTrials.gov |
What this trial studies
This study compares two surgical techniques for vestibulectomy aimed at treating provoked localized vulvodynia (PVD). It involves a prospective evaluation of patients who have experienced vulvar pain for at least three months and meet specific clinical criteria. Participants will undergo either a modified or traditional surgical technique, with outcomes assessed based on pain relief and recovery. The study aims to determine which technique offers better results for patients suffering from this condition.
Who should consider this trial
Good fit: Ideal candidates are non-pregnant women aged 18 and over with a diagnosis of provoked localized vulvodynia and significant vestibular tenderness.
Not a fit: Patients with other clinical reasons for dyspareunia or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide patients with more effective surgical options for managing vulvar pain.
How similar studies have performed: While there have been studies on surgical techniques for vulvodynia, this specific comparison of modified versus traditional vestibulectomy techniques is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Portland, Oregon
- Oregon Health and Science University — Portland, Oregon, United States (Recruiting)
Study contacts
- Principal investigator: Catherine Leclair, MD — Oregon Health and Science University
- Study coordinator: Women's Health Research Unit Confidential Recruitment Line
- Email: whru@ohsu.edu
- Phone: 503-494-3666
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.