Vestibulectomy Surgical Techniques Comparison Study for Vulvar Pain
This study is comparing two surgical techniques, Modified Technique and Traditional Technique, for treating vulvar pain (vulvodynia). Both techniques involve removing part of the vestibule, which is the entrance to the vagina. The Modified Technique uses a specific surgical flap and anesthesia, while the Traditional Technique uses a slightly different removal area and anesthesia. The study aims to see which technique is better at reducing pain. You may be able to join if you are a woman between 18 and 80 years old, have experienced provoked tenderness in the vestibule for at least 3 months, and meet other specific criteria for vulvar pain. The researchers will measure changes in your pain scores using a Tampon Test at 3, 6, and 12 months after surgery to see how well each technique works. The current recruitment status is unclear.
- Study design
- This interventional study plans to enroll 118 women to compare two different surgical techniques for vulvar pain.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 12 months after surgery to assess changes in pain scores.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Vestibulectomy Surgical Techniques Comparison Study
At a glance
Conditions
NCT05343182
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Oregon Health and Science University
Portland, Oregonstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Catherine Leclair, MD · PRINCIPAL_INVESTIGATOR · Oregon Health and Science University
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Change in Tampon Test pain scores from baseline to 3 monthsBaseline visit to 3 months after surgery
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 monthsBaseline visit to 6 months after surgery
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 monthsBaseline visit to 12 months after surgery
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.