Vestibulectomy Surgical Techniques Comparison Study

Part of paid clinical trials in Portland, Oregon.

Sponsor
Oregon Health and Science University
Study ID
NCT05343182
Status
Recruiting
Apply to this trial

Conditions

  • Vulvar Pain
  • Vulvodynia

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Modified Technique — OTHER
    This operation is performed using modified anesthesia care/deep sedation (MAC) for anesthesia. The vestibule is removed to the boundary of Harts line. The surgical flap for this procedure is the Hymen plus 1 cm of the vagina.
  • Traditional Technique — OTHER
    This operation is performed using an Laryngeal Mask Airway (LAM), (modified anesthesia care/deep sedation) for anesthesia. The vestibule is removed 0.5 to 1 cm beyond the boundary of the Hart's line. The Hymen plus 1 cm of the vagina is excised.

Study Details

Vestibulectomy Surgical Techniques Comparison Study

Key Dates

Start date
Oct 6, 2022
Status verified
Sep 2024
Primary completion
Jun 30, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
118 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Modified Vestibulectomy
  • Active Comparator: Traditional Vestibulectomy

Primary Outcome Measure

Change in Tampon Test pain scores from baseline to 3 months [ Time Frame: Baseline visit to 3 months after surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Oregon Health and Science UniversityPortlandOregon97239
Women's Health Research Unit Confidential Recruitment Line
[email protected]
503-494-3666

Find similar trials in Portland, OR

By research site
Oregon Health and Science University· Portland, OR

Related Studies