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RecruitingAccepts healthy volunteersPhase 4

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

University of Louisville · NCT06644261

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · Women only
Healthy volunteers
Accepted
Study type
Interventional · Phase 4
Target enrollment
40
US sites recruiting
1
Study start
June 27, 2024
Record last updated
December 18, 2024

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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.

Being studied: Bupivacaine injection

Conditions: Pudendal Neuralgia; Chronic Pelvic Pain Syndrome

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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)

Recruiting US locations

  • University of Louisville Division of Urogynecology and Reconstructive Pelvic Surgery

    Louisville, KY 40202

    Site contact: Laurel Carbone, MD · 502-588-7660 · laurel.carbone@louisville.edu

Study contacts (from the official record)

  • Laurel Carbone, MD · 502-588-7660 · laurel.carbone@louisville.edu
  • Sean Francis, MD · 502-588-7660 · sean.francis@louisville.edu
Transvaginal Versus Fluoroscopy-guided Trans Gluteal Pudendal… (NCT06644261) | Bored Studies