← Back to Search

Vestibulectomy Techniques for Vulvodynia

N/A
Recruiting
Led By Catherine Leclair, MD
Research Sponsored by Oregon Health and Science University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Prior vestibulectomy or hymen surgery
Prior or current use of testosterone dosed for gender affirmation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline visit to 3 months after surgery
Awards & highlights
No Placebo-Only Group

Summary

This trial is comparing two different surgical techniques for treating a condition called vestibulodynia.

Who is the study for?
This trial is for adults over 18 with vulvodynia, experiencing tenderness in the vestibule area for at least 3 months. Participants must have a certain level of pain during cotton swab and tampon tests, access to phone and internet, and be willing to undergo pelvic floor physical therapy. Those who've had previous vestibulectomy or hymen surgery, use testosterone for gender affirmation, are pregnant, or have other causes of dyspareunia like endometriosis can't join.
What is being tested?
The study compares two surgical techniques used in vestibulectomy (surgery for vulvodynia) - the Traditional Technique versus a Modified Technique. The goal is to see which method provides better outcomes for patients suffering from this condition.
What are the potential side effects?
While specific side effects aren't listed here, common risks associated with surgical procedures may include infection, bleeding, pain at the incision site, scarring and potential changes in sexual sensation.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had surgery on my vestibule or hymen.
Select...
I am currently using or have used testosterone for gender affirmation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline visit to 3 months after surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline visit to 3 months after surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Tampon Test pain scores from baseline to 3 months
Change in pain scores from baseline to 12 months
Change in pain scores from baseline to 6 months

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Traditional VestibulectomyActive Control1 Intervention
Group II: Modified VestibulectomyActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Oregon Health and Science UniversityLead Sponsor
1,008 Previous Clinical Trials
7,414,071 Total Patients Enrolled
3 Trials studying Vulvodynia
96 Patients Enrolled for Vulvodynia
Catherine Leclair, MDPrincipal InvestigatorOregon Health and Science University
3 Previous Clinical Trials
127 Total Patients Enrolled
2 Trials studying Vulvodynia
77 Patients Enrolled for Vulvodynia

Media Library

Modified Technique Clinical Trial Eligibility Overview. Trial Name: NCT05343182 — N/A
Vulvodynia Research Study Groups: Traditional Vestibulectomy, Modified Vestibulectomy
Vulvodynia Clinical Trial 2023: Modified Technique Highlights & Side Effects. Trial Name: NCT05343182 — N/A
Modified Technique 2023 Treatment Timeline for Medical Study. Trial Name: NCT05343182 — N/A
~47 spots leftby Jun 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top