Modified Vestibulectomy for Vulvodynia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Oregon Health and Science University, Portland, OR
Vulvodynia+1 More
Modified Technique - Other
Eligibility
18+
Female
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Study Summary

Vestibulectomy Surgical Techniques Comparison Study

Eligible Conditions

  • Vulvodynia
  • Vulvar Pain

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 0 Secondary · Reporting Duration: Baseline visit to 3 months after surgery

Month 12
Change in pain scores from baseline to 12 months
Month 3
Change in Tampon Test pain scores from baseline to 3 months
Month 6
Change in pain scores from baseline to 6 months

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Modified Vestibulectomy
1 of 2
Traditional Vestibulectomy
1 of 2
Active Control

118 Total Participants · 2 Treatment Groups

Primary Treatment: Modified Vestibulectomy · No Placebo Group · N/A

Modified Vestibulectomy
Other
ActiveComparator Group · 1 Intervention: Modified Technique · Intervention Types: Other
Traditional Vestibulectomy
Other
ActiveComparator Group · 1 Intervention: Traditional Technique · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline visit to 3 months after surgery

Trial Background

Prof. Catherine M Leclair, MD
Principal Investigator
Oregon Health and Science University
Closest Location: Oregon Health and Science University · Portland, OR
Photo of oregon health and science university  1Photo of oregon health and science university  2Photo of oregon health and science university  3
2012First Recorded Clinical Trial
2 TrialsResearching Vulvodynia
523 CompletedClinical Trials

Eligibility Criteria

Age 18+ · Female Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are willing to engage in pelvic floor physical therapy (PT).

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.