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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Modified Technique
Other interventionThis 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
Other interventionThis 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.
Treatment groups
118 Participants
are divided into 2 treatment groupsGroup A: Modified VestibulectomyActive comparator 1 intervention
Group B: Traditional VestibulectomyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Tampon Test pain scores from baseline to 3 months
The change from baseline in pain measured by the Tampon Test at 3 months after surgery. The tampon test is a validated tool used to measure (vulva) vestibular skin pain by having participants insert and remove a tampon. Participants will be asked to rate their pain along a 100 mm Visual Analog Scale on a scale of 0 (No pain) to 10 (Pain as bad as you can imagine). This test will occur at baseline and 3 months follow up.
Time frame
Baseline visit to 3 months after surgery2
Change in pain scores from baseline to 6 months
The change from baseline in pain measured by the Tampon Test at 6 months after surgery. The tampon test is a validated tool used to measure (vulva) vestibular skin pain by having participants insert and remove a tampon. Participants will be asked to rate their pain along a 100 mm Visual Analog Scale on a scale of 0 (No pain) to 10 (Pain as bad as you can imagine). This test will occur at baseline and 6 months follow up.
Time frame
Baseline visit to 6 months after surgery3
Change in pain scores from baseline to 12 months
The change from baseline in pain measured by the Tampon Test at 12 months after surgery. The tampon test is a validated tool used to measure (vulva) vestibular skin pain by having participants insert and remove a tampon. Participants will be asked to rate their pain along a 100 mm Visual Analog Scale on a scale of 0 (No pain) to 10 (Pain as bad as you can imagine). This test will occur at baseline and 12 months follow up.
Time frame
Baseline visit to 12 months after surgerySponsors and contacts
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Source ClinicalTrials.gov