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

RecruitingPhase 4Ages 18 Years - anyFemaleUniversity of Louisville
NCT06644261 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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)
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What it tests

  • Bupivacaine injection
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Where

1 site
University of Louisville Division of Urogynecology and Reconstructive Pelvic Surgery
Louisville, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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