Transvaginal Versus Fluoroscopy-guided Trans Gluteal Pudendal Nerve Block for Pudendal Neuralgia

December 13, 2024 updated by: Sean Francis, MD, University of Louisville

Transvaginal Versus Fluoroscopy-guided Trans Gluteal Pudendal Nerve Block for Pudendal Neuralgia and Chronic Pelvic Pain: a Prospective, Noninferiority, Randomized Controlled Trial

Chronic pain affecting the pelvic and urogenital area is a major clinical problem and can have a profound impact on quality of life and health care costs. Pelvic pain arising from entrapment or neuropathy of the pudendal nerve is known as pudendal neuralgia, which results in chronic perineal pain. This pain syndrome is difficult to diagnose and patients with pudendal neuralgia may present to providers with refractory chronic pelvic pain. Pudendal nerve infiltration or pudendal nerve block (PNB) serves as a diagnostic tool and treatment modality for patients with this condition. To date, there are no published randomized controlled trials comparing imaging-guided PNB to transvaginal finger-guided PNB. While one can assume that image-guided nerve blocks will provide better accuracy for injection and potentially better efficacy in pain relief as a result, no published data exists comparing the outcomes and efficacy between modalities.

The purpose of this prospective, non-inferiority, randomized controlled trial is to compare the efficacy of pain relief from bilateral transvaginal finger-guided pudendal nerve block versus bilateral fluoroscopy-guided trans gluteal pudendal nerve block for patients with pudendal neuralgia.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Primary objective:

Determine the efficacy of pain relief comparing the change in Visual Analog Scale (VAS) from baseline to 6 weeks in women randomized to Transvaginal PNB (without imaging) versus Trans gluteal fluoroscopy-guided PNB.

Upon completion of 6-week follow-up, participants will be given the option to crossover to the alternative treatment arm

Secondary Objectives:

Characterize the effect of either pudendal nerve block approach using the following validated questionnaires

  • PROMIS-29 (degree of pain intensity and bother across health domains)
  • Pain catastrophizing scale (emotional and cognitive impact of pain)
  • Short-form McGill (qualitative pain)
  • Patient satisfaction with medical care
  • Baseline demographics
  • Baseline VAS
  • Adverse events
  • Determine the time to peak pain relief and duration of injection pain relief

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • University of Louisville Division of Urogynecology and Reconstructive Pelvic Surgery
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • women >18 years
  • English speaking/reading
  • Diagnosis of pudendal neuralgia OR chronic pelvic pain with pain in the distribution of the pudendal nerve for 3 months or longer
  • Minimum pain/bother score of 4/10
  • Desire for pudendal nerve block

Exclusion Criteria:

  • Contraindication to pudendal nerve block (examples: skin or vaginal infection, bupivacaine allergy, uncorrected coagulopathy)
  • Pregnant or intending to become pregnant during the study
  • Pudendal nerve block from any route within the last 3 months
  • Major pelvic surgery within the last 3 months (examples: hysterectomy, prolapse repair, midurethral sling)
  • Neurologic disease affecting the perineum (examples: spinal cord injury, multiple sclerosis)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Transvaginal pudendal nerve block
Participants in this arm will receive 10 mL bupivacaine injected into bilateral pudendal nerves via transvaginal approach. This is performed by palpating 1 cm superior and medial to the ischial spine. Participants will receive an injection each 2 weeks, for a total of 3 injections over 6 weeks.
Drug: Bupivacaine injection

Transvaginal: Palpation 1 cm superior and medial to ischial spine to locate pudendal nerve. 22 gauge spinal needle with trumpet will be placed at this location. Upon negative aspiration, 10 mL of 0.25% bupivacaine will be injected bilaterally.

Fluoroscopic: Anesthesia Pain medicine fluoroscopy guided injection of 5 mL 0.25% bupivacaine bilaterally in the area of the pudendal nerve based on surrounding landmarks
Other: Fluoroscopy guided pudendal nerve block
Participants in this arm will receive 5 mL bupivacaine injected into bilateral pudendal nerves via fluoroscopic guided trans gluteal approach. They will receive one injection over the 6-week duration.
Drug: Bupivacaine injection

Transvaginal: Palpation 1 cm superior and medial to ischial spine to locate pudendal nerve. 22 gauge spinal needle with trumpet will be placed at this location. Upon negative aspiration, 10 mL of 0.25% bupivacaine will be injected bilaterally.

Fluoroscopic: Anesthesia Pain medicine fluoroscopy guided injection of 5 mL 0.25% bupivacaine bilaterally in the area of the pudendal nerve based on surrounding landmarks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Absolute change in Visual Analog Scale (VAS) for pain
Time Frame: 6 weeks
VAS will be obtained at baseline, post-procedure, weekly until 6 weeks, scale is 0-100 mm with higher scores indicated more pain severity
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Louisville

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 27, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 14, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 16, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB #24.0319

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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