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Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
FEMALE
ID05343182

Comparison of Modified and Traditional Vestibulectomy Surgical Techniques for Treating Provoked Localized Vulvodynia in Women

Led by Oregon Health and Science University · Updated on 2024-09-19

118

Participants Needed

1

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

This research aims to compare two different surgical techniques for treating Provoked Localized Vulvodynia PVD, a condition causing vulvar pain. The study evaluates Modified Vestibulectomy and Traditional Vestibulectomy to understand their effects on pain relief. Participants are women aged 18 to 80 years who have experienced provoked tenderness in the vestibule for at least three months and meet specific clinical criteria for PVD. The study involves two groups receiving either the Modified Technique or the Traditional Technique of vestibulectomy surgery. The Modified Technique is performed under modified anesthesia caredeep sedation MAC and removes the vestibule to the boundary of Harts line, excising the hymen plus 1 cm of the vagina. The Traditional Technique uses a Laryngeal Mask Airway with MAC and removes the vestibule 0.5 to 1 cm beyond Harts line, also excising the hymen plus 1 cm of the vagina. Participants will be followed for up to 12 months after surgery, with pain measured at baseline and at 3, 6, and 12 months post-surgery using the Tampon Test and verbal pain scores. Assessments include evaluating pain changes specifically in the vestibule area. The study tracks participant adherence and monitors outcomes to assess the surgical techniques impact on vulvar pain over time.

CONDITIONS

Brief Title

Vestibulectomy Surgical Techniques Comparison Study

Research Team

W

Women's Health Research Unit Confidential Recruitment Line

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