Actively Recruiting
Vestibulectomy: A Prospective Comparison of Two Surgical Techniques for the Treatment of Provoked Localized Vulvodynia (PVD)
Led by Oregon Health and Science University · Updated on 2024-09-19
118
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare two different surgical techniques for treating Provoked Localized Vulvodynia (PVD), a condition causing vulvar pain. The study evaluates Modified Vestibulectomy and Traditional Vestibulectomy to understand their effects on pain relief. Participants are women aged 18 to 80 years who have experienced provoked tenderness in the vestibule for at least three months and meet specific clinical criteria for PVD. The study involves two groups receiving either the Modified Technique or the Traditional Technique of vestibulectomy surgery. The Modified Technique is performed under modified anesthesia care/deep sedation (MAC) and removes the vestibule to the boundary of Hart's line, excising the hymen plus 1 cm of the vagina. The Traditional Technique uses a Laryngeal Mask Airway with MAC and removes the vestibule 0.5 to 1 cm beyond Hart's line, also excising the hymen plus 1 cm of the vagina. Participants will be followed for up to 12 months after surgery, with pain measured at baseline and at 3, 6, and 12 months post-surgery using the Tampon Test and verbal pain scores. Assessments include evaluating pain changes specifically in the vestibule area. The study tracks participant adherence and monitors outcomes to assess the surgical techniques' impact on vulvar pain over time.
CONDITIONS
Brief Title
Vestibulectomy Surgical Techniques Comparison Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 years or older and up to 80 years
- Reported provoked tenderness to the vestibule for at least 3 months
- Meet Friedrich's criteria for Provoked Localized Vulvodynia (PVD) and ISSVD consensus for vulvar pain
- Cotton swab test score of 4 or higher out of 10 in 4 of 6 vestibule points
- Cotton swab test score of 2 or less out of 10 for labia majora, labia minora, intra labial sulcus, and perineum
- Ability to insert a regular Tampax tampon
- Baseline Tampon Test pain score of 30 or higher
- Access to phone and internet
- Willingness to participate in pelvic floor physical therapy
- Women over 45 years must have a maturation index of less than 10% parabasal cells or agree to local estrogen treatment until this is achieved
You will not qualify if you...
- Pregnancy
- Other clinical causes of dyspareunia such as endometriosis pain, chronic pelvic pain, or vulvar dermatoses like psoriasis or lichen sclerosus
- Unable or unwilling to complete baseline assessments
- Prior vestibulectomy or hymen surgery
- Prior or current use of testosterone for gender affirmation
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo one of two surgical techniques for vestibulectomy under anesthesia, followed by immediate post-operative care.
1 visit (in-person surgery and immediate recovery)
Duration - Up to 12 months
Participants are monitored for recovery and changes in pain scores up to 12 months after surgery.
Follow-up visits at 3 months, 6 months, and 12 months (in-person or remote)
Trial Site Locations
Total: 1 location
1
Oregon Health and Science University
Portland, Oregon, United States, 97239
Actively Recruiting
Research Team
W
Women's Health Research Unit Confidential Recruitment Line
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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