search
Back to results

Vestibulectomy Surgical Techniques Comparison Study

Primary Purpose

Vulvar Pain, Vulvodynia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Modified Technique
Traditional Technique
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vulvar Pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Oregon Health and Science UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Modified Vestibulectomy

Traditional Vestibulectomy

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
April 18, 2022
Last Updated
October 24, 2022
Sponsor
Oregon Health and Science University
search

1. Study Identification

Unique Protocol Identification Number
NCT05343182
Brief Title
Vestibulectomy Surgical Techniques Comparison Study
Official Title
Vestibulectomy: A Prospective Comparison of Two Surgical Techniques for the Treatment of Provoked Localized Vulvodynia (PVD)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 6, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvar Pain, Vulvodynia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
118 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Modified Vestibulectomy
Arm Type
Active Comparator
Arm Title
Traditional Vestibulectomy
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Modified Technique
Intervention Description
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
Intervention Name(s)
Traditional Technique
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Tampon Test pain scores from baseline to 3 months
Description
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 surgery
Title
Change in pain scores from baseline to 6 months
Description
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 surgery
Title
Change in pain scores from baseline to 12 months
Description
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 surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 f. Phone and internet access e. Willingness to engage in pelvic floor physical therapy (PT) Exclusion Criteria: 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 Prior or current use of testosterone dosed for gender affirmation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Women's Health Research Unit Confidential Recruitment Line
Phone
503-494-3666
Email
whru@ohsu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Leclair, MD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Women's Health Research Unit Confidential Recruitment Line
Phone
503-494-3666
Email
whru@ohsu.edu

12. IPD Sharing Statement

Learn more about this trial

Vestibulectomy Surgical Techniques Comparison Study

We'll reach out to this number within 24 hrs