RECRUITING

Vestibulectomy Surgical Techniques Comparison Study

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Vestibulectomy Surgical Techniques Comparison Study

Official Title

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

Quick Facts

Study Start:2022-10-06

Study Completion:2027-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05343182

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.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Women's Health Research Unit Confidential Recruitment Line

CONTACT

503-494-3666

whru@ohsu.edu

Principal Investigator

Catherine Leclair, MD

PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Study Locations (Sites)

Oregon Health and Science University

Portland, Oregon, 97239

United States

Collaborators and Investigators

Sponsor: Oregon Health and Science University

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-06

Study Completion Date2027-06

Study Record Updates

Study Start Date2022-10-06

Study Completion Date2027-06

Terms related to this study

Additional Relevant MeSH Terms

Vulvar Pain
Vulvodynia