Recruiting

Observational Study

Sponsor:

University of Virginia

Code:

NCT06021782

Conditions

Anesthesia

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

All subjects-Observation

Study Details

Brief summary:

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.

Conditions

Anesthesia

Study ID

NCT06021782

Start date

May 13, 2021

Status verified date

Jan, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Scheduled to undergo transvaginal ultrasound at the Fetal Care Center (FCC) or Gynecology clinic
  • Patients undergoing pelvic floor surgery at either the Main OR or outpatient surgery center at UVA will be included. This includes surgeries performed by surgeons in the Department of OBGYN, Division of Pelvic Medicine and Reconstructive Surgery, and includes surgeries for repair of prolapse, urinary incontinence, fistula, urethral diverticulum, or other pelvic floor issues.
  • >18 years age
  • English-speaking

Exclusion Criteria:

• Refusal to participate

Study Design

Enrollment

24 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

All subjects-Observation

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.

Primary outcome measure

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

Central Contacts and Locations

Locations

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

Monique Vaughan, MD

4349242103mv4w@UVAHEALTH.ORG

More Information

Sponsor

University of Virginia

Last update posted

Jan 29, 2025

Last verified

Jan, 2025

Keywords

  • pudendal nerve

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2025-01-29.