Vestibulectomy Surgical Techniques Comparison Study

NCT ID: NCT05343182

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 118 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-06
• Study Completion Date: 2027-06-30

Brief Summary

Vestibulectomy Surgical Techniques Comparison Study

Detailed Description

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

Conditions

Vulvar Pain; Vulvodynia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Modified Vestibulectomy

Group Type: ACTIVE_COMPARATOR

Modified Technique

Intervention Type: OTHER

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 Vestibulectomy

Group Type: ACTIVE_COMPARATOR

Traditional Technique

Intervention Type: OTHER

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.

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Catherine M Leclair, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Catherine Leclair, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Oregon Health and Science University

Portland, Oregon, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Women's Health Research Unit Confidential Recruitment Line

Role: CONTACT

whru@ohsu.edu

503-494-3666

Facility Contacts

Women's Health Research Unit Confidential Recruitment Line

Role: primary

whru@ohsu.edu

503-494-3666

Other Identifiers

OHSU IRB 24107

Identifier Type: -

Identifier Source: org_study_id