Vestibulectomy Surgical Techniques Comparison Study

Description

Vestibulectomy Surgical Techniques Comparison Study

Conditions

Vulvar Pain, Vulvodynia

Study Overview

Study Details

Study overview

Vestibulectomy Surgical Techniques Comparison Study

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

Vestibulectomy Surgical Techniques Comparison Study

Condition
Vulvar Pain
Intervention / Treatment

-

Contacts and Locations

Portland

Oregon Health and Science University, Portland, Oregon, United States, 97239

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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. 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

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Oregon Health and Science University,

Catherine Leclair, MD, PRINCIPAL_INVESTIGATOR, Oregon Health and Science University

Study Record Dates

2027-06