Characterization of the Pudendal Nerve with Transvaginal Ultrasonography

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
University of Virginia
Study ID
NCT06021782
Status
Recruiting
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Conditions

  • Anesthesia

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • All subjects-Observation — OTHER
    The sonographer or study team member will scan the lateral vaginal walls (Left and right) directing the probe slightly caudad in direction of the ischial spine (IS). The IS is very echogenic and easily identifiable (bony landmark). Anatomically, the pudendal nerve courses underneath the IS and travels with the vascular bundle of the pudendal artery and pudendal vein. The artery and the vein will be identified using color flow Doppler at the time of the scan. These landmarks, IS, pudendal artery and vein will serve as the basis for the identification of the pudendal nerve.

Study Details

This is a feasibility study characterizing the ability of transvaginal ultrasonography to identify the pudendal nerve. Today, the pudendal nerve block is typically accomplished through blind landmark techniques, thus limiting its success. To date, there has never been an attempt to determine if the visualization of the pudendal nerve would be possible using transvaginal ultrasound with existing technology; nor to perform this procedure transvaginally with the assistance of ultrasound.

Key Dates

Start date
May 13, 2021
Status verified
Jan 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2026

Study Design

Enrollment
24 participants (estimated)

Arms

  • Arm: All subjects
    Patients scheduled to have their transvaginal ultrasound for medical reasons at the fetal care center and gynecology clinic will be asked to participate in this study. Also, patients undergoing pelvic floor surgery at either the Main OR or outpatient surgery center at UVA will be asked to participate.

Primary Outcome Measure

Observing the Pudendal Nerve [ Time Frame: day of study participate (1 day per participant) ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of VirginiaCharlottesvilleVirginia22903
Monique Vaughan, MD
[email protected]
4349242103

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By research site
University of Virginia· Charlottesville, VA

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