Actively Recruiting

Phase 4
Age: 18Years +
FEMALE
Healthy Volunteers
NCT06644261

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

Led by University of Louisville · Updated on 2024-12-18

40

Participants Needed

1

Research Sites

261 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Women over 18 years old
  • Able to read and speak English
  • Diagnosed with pudendal neuralgia or chronic pelvic pain with pain in pudendal nerve area for 3 months or longer
  • Pain or bother score of at least 4 out of 10
  • Desire to receive pudendal nerve block treatment
Not Eligible

You will not qualify if you...

  • Contraindications to pudendal nerve block such as skin or vaginal infection, allergy to bupivacaine, or uncorrected bleeding problems
  • Pregnant or planning pregnancy during the study
  • Received pudendal nerve block by any method in the last 3 months
  • Major pelvic surgery in the last 3 months (e.g., hysterectomy, prolapse repair, midurethral sling)
  • Neurologic disease affecting the perineum (e.g., spinal cord injury or multiple sclerosis)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Louisville Division of Urogynecology and Reconstructive Pelvic Surgery

Louisville, Kentucky, United States, 40202

Actively Recruiting

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Research Team

L

Laurel Carbone, MD

CONTACT

S

Sean Francis, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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