Recruiting

Vestibulectomy

Sponsor:

Oregon Health and Science University

Code:

NCT05343182

Conditions

Vulvar Pain

Vulvodynia

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Modified Technique

Traditional Technique

Study Details

Brief summary:

Vestibulectomy Surgical Techniques Comparison Study

Conditions

Vulvar Pain

Vulvodynia

Study ID

NCT05343182

Start date

Oct 6, 2022

Status verified date

Sep, 2024

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

118 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Modified Vestibulectomy

active comparator: Traditional Vestibulectomy

Interventions

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.

Primary outcome measure

  • Change in Tampon Test pain scores from baseline to 3 months [ Time Frame: Baseline visit to 3 months after surgery ]
  • Change in pain scores from baseline to 6 months [ Time Frame: Baseline visit to 6 months after surgery ]
  • Change in pain scores from baseline to 12 months [ Time Frame: Baseline visit to 12 months after surgery ]

Central Contacts and Locations

Central contacts

Women's Health Research Unit Confidential Recruitment Line

503-494-3666whru@ohsu.edu

Locations

Oregon Health and Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Women's Health Research Unit Confidential Recruitment Line

503-494-3666whru@ohsu.edu

More Information

Sponsor

Oregon Health and Science University

Last update posted

Sep 19, 2024

Last verified

Sep, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2024-09-19.