NCT06021782

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
14mo left

Started May 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
May 2021Dec 2027

Study Start

First participant enrolled

May 13, 2021

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

August 26, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 1, 2023

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

September 25, 2026

Status Verified

September 1, 2026

Enrollment Period

6.6 years

First QC Date

August 26, 2023

Last Update Submit

September 23, 2026

Conditions

Anesthesia

Keywords

pudendal nerve

Outcome Measures

Primary Outcomes (1)

  • Observing the Pudendal Nerve

    We will use this study to determine if we can use transvaginal ultrasound to visualize the pudendal nerve through transvaginal ultrasound.

    day of study participate (1 day per participant)

Study Arms (1)

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.

Other: All subjects-Observation

Interventions

All subjects-ObservationOTHER

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.

All subjects

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient scheduled to undergo transvaginal ultrasound at the Fetal Care Center (FCC) or Gynecology clinic. Or 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.

You may qualify if:

  • 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

You may not qualify if:

  • Refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

Related Publications (4)

  • KOBAK AJ, EVANS EF, JOHNSON GR. Transvaginal pudendal nerve block; a simple procedure for effective anesthesia in operative vaginal delivery. Am J Obstet Gynecol. 1956 May;71(5):981-9. No abstract available.

    PMID: 13313599BACKGROUND

  • Langhoff-Roos J, Lindmark G. Analgesia and maternal side effects of pudendal block at delivery. A comparison of three local anesthetics. Acta Obstet Gynecol Scand. 1985;64(3):269-72. doi: 10.3109/00016348509155127.

    PMID: 3893025BACKGROUND

  • Arslan M, Yazici G, Dilek U. Pudendal nerve block for pain relief in episiotomy repair. Int J Gynaecol Obstet. 2004 Nov;87(2):151-2. doi: 10.1016/j.ijgo.2004.06.020. No abstract available.

    PMID: 15491563BACKGROUND

  • Nikpoor P, Bain E. Analgesia for forceps delivery. Cochrane Database Syst Rev. 2013 Sep 30;9(9):CD008878. doi: 10.1002/14651858.CD008878.pub2.

    PMID: 24085633BACKGROUND

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 26, 2023

First Posted

September 1, 2023

Study Start

May 13, 2021

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

September 25, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)