Vestibulectomy Surgical Techniques Comparison Study

• Sponsor: Oregon Health and Science University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05343182
• Collaborator: (none)
• Enrollment: 118
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 36
• Patients Per Site Per Month: 3.3

Study Details

Study Description

Brief Summary

Vestibulectomy Surgical Techniques Comparison Study

Condition or Disease	Intervention/Treatment	Phase
Vulvar Pain; Vulvodynia	Other: Modified Technique; Other: Traditional Technique	N/A

Detailed Description

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 118 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Vestibulectomy: A Prospective Comparison of Two Surgical Techniques for the Treatment of Provoked Localized Vulvodynia (PVD)
• Anticipated Study Start Date: Jun 1, 2022
• Anticipated Primary Completion Date: Jun 1, 2024
• Anticipated Study Completion Date: Jun 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Modified Vestibulectomy	Other: Modified Technique; This operation is performed using modified anesthesia care/deep sedation (MAC) for anesthesia. The vestibule is removed to the boundary of Harts line. The surgical flap for this procedure is the Hymen plus 1 cm of the vagina.
Active Comparator: Traditional Vestibulectomy	Other: Traditional Technique; This operation is performed using an Laryngeal Mask Airway (LAM), (modified anesthesia care/deep sedation) for anesthesia. The vestibule is removed 0.5 to 1 cm beyond the boundary of the Hart's line. The Hymen plus 1 cm of the vagina is excised.

Outcome Measures

Primary Outcome Measures

1. Change in Tampon Test pain scores from baseline to 3 months [Baseline visit to 3 months after surgery]

   The change from baseline in pain measured by the Tampon Test at 3 months after surgery. The tampon test is a validated tool used to measure (vulva) vestibular skin pain by having participants insert and remove a tampon. Participants will be asked to rate their pain along a 100 mm Visual Analog Scale on a scale of 0 (No pain) to 10 (Pain as bad as you can imagine). This test will occur at baseline and 3 months follow up.

2. Change in pain scores from baseline to 6 months [Baseline visit to 6 months after surgery]

   The change from baseline in pain measured by the Tampon Test at 6 months after surgery. The tampon test is a validated tool used to measure (vulva) vestibular skin pain by having participants insert and remove a tampon. Participants will be asked to rate their pain along a 100 mm Visual Analog Scale on a scale of 0 (No pain) to 10 (Pain as bad as you can imagine). This test will occur at baseline and 6 months follow up.

3. Change in pain scores from baseline to 12 months [Baseline visit to 12 months after surgery]

   The change from baseline in pain measured by the Tampon Test at 12 months after surgery. The tampon test is a validated tool used to measure (vulva) vestibular skin pain by having participants insert and remove a tampon. Participants will be asked to rate their pain along a 100 mm Visual Analog Scale on a scale of 0 (No pain) to 10 (Pain as bad as you can imagine). This test will occur at baseline and 12 months follow up.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

1. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oregon Health and Science University	Portland	Oregon	United States	97239

Sponsors and Collaborators

• Oregon Health and Science University

Investigators

• Principal Investigator: Catherine Leclair, MD, Oregon Health and Science University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Catherine M Leclair, MD, Professor, Oregon Health and Science University
• ClinicalTrials.gov Identifier: NCT05343182
• Other Study ID Numbers: OHSU IRB 24107
• First Posted: Apr 25, 2022
• Last Update Posted: Apr 25, 2022
• Last Verified: Apr 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Vulvodynia

Study Results

No Results Posted as of Apr 25, 2022