Vestibulectomy Surgical Techniques Comparison Study

Vulvodynia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05343182
• Other study ID #: OHSU IRB 24107
• Status: Recruiting
• Phase: N/A
• Start date: October 6, 2022
• Est. completion date: June 2025

Study information

• Verified date: November 2023
• Source: Oregon Health and Science University
• Contact: Women's Health Research Unit Confidential Recruitment Line
• Phone: 503-494-3666
• Email: whru[@]ohsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Vestibulectomy Surgical Techniques Comparison Study

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 118
• Est. completion date: June 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Vulvar Pain
• Vulvodynia

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Oregon Health and Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Tampon Test pain scores from baseline to 3 months	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.	Baseline visit to 3 months after surgery
Primary	Change in pain scores from baseline to 6 months	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.	Baseline visit to 6 months after surgery
Primary	Change in pain scores from baseline to 12 months	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.	Baseline visit to 12 months after surgery