Vestibulectomy Surgical Techniques Comparison Study

Last updated: September 6, 2024
Sponsor: Oregon Health and Science University
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Traditional Technique

Modified Technique

Clinical Study ID

NCT05343182
OHSU IRB 24107
  • Ages 18-80
  • Female

Study Summary

Vestibulectomy Surgical Techniques Comparison Study

Eligibility Criteria

Inclusion

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 criteriafor PVD44-45 and supported by the ISSVD Terminology Consensus Definition45 forvulvar pain. Subjects who are >45years of age must have either have a maturationindex52 of < 10% parabasal cells or willingness to participate in local estrogenreplacement until achieving this same clinical result.

  2. Cotton swab Test30-31 mean verbal rating score of ≥4/10 in 4 of 6 defined points ofthe vestibule (2, 4, 6, 8, 10, 12 o'clock) and cotton swab test verbal score ≤ 2/10for 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

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

Total Participants: 118
Treatment Group(s): 2
Primary Treatment: Traditional Technique
Phase:
Study Start date:
October 06, 2022
Estimated Completion Date:
June 30, 2027

Study Description

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

Connect with a study center

  • Oregon Health and Science University

    Portland, Oregon 97239
    United States

    Active - Recruiting

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