Vestibulectomy Surgical Techniques Comparison Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-80
SponsorOregon Health and Science University

About this trial

Vestibulectomy Surgical Techniques Comparison Study

Eligibility criteria

Qualifiers

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.

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

Ability to insert a regular Tampax® tampon

Baseline Tampon Test verbal pain score ≥430

Disqualifiers

Pregnancy

Any other clinical reason for dyspareunia (endometriosis pain, chronic pelvic pain, vulvar dermatoses such as psoriasis, lichen sclerosus)

Unable or unwilling to complete baseline assessments

Prior vestibulectomy or hymen surgery

Trial design

Treatments tested in this trial

  • Modified Technique
  • Traditional Technique

Treatment groups

118 Participants
are divided into 2 treatment groups