Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
FEMALE
NCT05343182

Vestibulectomy Surgical Techniques Comparison Study

Led by Oregon Health and Science University · Updated on 2024-09-19

118

Participants Needed

1

Research Sites

242 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Vestibulectomy Surgical Techniques Comparison Study

CONDITIONS

Official Title

Vestibulectomy Surgical Techniques Comparison Study

Who Can Participate

Age: 18Years - 80Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female, aged 18 years or older and up to 80 years
  • Reported provoked tenderness to the vestibule for at least 3 months meeting Friedrich's criteria for PVD and supported by ISSVD definition for vulvar pain
  • Cotton swab test mean pain score of 4 or higher out of 10 at 4 of 6 vestibule points, with scores 2 or less in labia majora, minora, intra labial sulcus, and perineum
  • Ability to insert a regular Tampax tampon
  • Baseline Tampon Test verbal pain score of 30 or higher
  • Phone and internet access
  • Willingness to engage in pelvic floor physical therapy
  • If over 45 years old, either maturation index below 10% parabasal cells or willingness to use local estrogen until this is achieved
Not Eligible

You will not qualify if you...

  • Pregnancy
  • Any other clinical cause of painful intercourse such as endometriosis, chronic pelvic pain, or vulvar skin diseases like psoriasis or lichen sclerosus
  • Unable or unwilling to complete baseline assessments
  • Previous vestibulectomy or hymen surgery
  • Prior or current use of testosterone for gender affirmation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Oregon Health and Science University

Portland, Oregon, United States, 97239

Actively Recruiting

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Research Team

W

Women's Health Research Unit Confidential Recruitment Line

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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