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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Vestibulectomy Surgical Techniques Comparison Study

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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)

Locations
United States
Oregon
Oregon Health and Science University
RECRUITING
Portland
Contact Information
Primary
Women's Health Research Unit Confidential Recruitment Line
whru@ohsu.edu
503-494-3666
Time Frame
Start Date: 2022-10-06
Estimated Completion Date: 2027-06
Participants
Target number of participants: 118
Treatments
Active_comparator: Modified Vestibulectomy
Active_comparator: Traditional Vestibulectomy
Related Therapeutic Areas
Sponsors
Leads: Oregon Health and Science University

This content was sourced from clinicaltrials.gov