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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline visit to 3 months after surgery

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline visit to 3 months after surgery

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Trial Design

2Treatment groups

Active Control

Group I: Traditional VestibulectomyActive Control1 Intervention

Group II: Modified VestibulectomyActive Control1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Oregon Health and Science UniversityLead Sponsor

974 Previous Clinical Trials

7,385,794 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical research involve participants who are of legal age?

"The inclusion parameters for this research are designed to include individuals over 18 and below the age of 80."

Answered by AI

Who meets the eligibility criteria for this clinical trial?

"This clinical trial needs to recruit 118 individuals living with vulvodynia between 18 and 80 years of age. Participants should match the following criteria: reported discomfort in the vestibule for more than 3 months according to Friedrich's PVD44-45, an ISSVD Terminology Consensus Definition45 diagnosis, a maturation index52 lower than 10% or willingness to use local estrogen replacement until this result is achieved, Cotton swab Test30-31 mean verbal rating score higher than 4/10 on at least four points of the vestibule (2,4,6 8,,10 & 12 o'clock) and lower or"

Answered by AI

How many participants are actively involved in this scientific exploration?

"Affirmative. The information hosted on clinicaltrials.gov shows that the trial, which was first launched October 6th 2022, is looking for volunteers to join their study. 118 subjects are needed from 1 research centre."

Answered by AI

Are there any open registration slots for this clinical experiment?

"Affirmative. Per the data on clinicaltrials.gov, this medical trial is actively accepting patients. It was first published October 6th 2022 and last updated 24 days later; 118 individuals are needed across 1 location for completion of the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Vestibulectomy Surgical Techniques Comparison Study

Catherine M Leclair, MD 2022. "Vestibulectomy Surgical Techniques Comparison Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05343182.

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