NCT06644261 Transvaginal Versus Fluoroscopy-guided Trans Gluteal Pudendal Nerve Block for Pudendal Neuralgia
| NCT ID | NCT06644261 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Louisville |
| Condition | Pudendal Neuralgia |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-06-27 |
| Primary Completion | 2025-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 40 participants in total. It began in 2024-06-27 with a primary completion date of 2025-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06644261 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Pudendal Neuralgia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06644261 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06644261 currently recruiting?
Yes, NCT06644261 is actively recruiting participants. Contact the research team at laurel.carbone@louisville.edu for enrollment information.
Where is the NCT06644261 trial being conducted?
This trial is being conducted at Louisville, United States.
Who is sponsoring the NCT06644261 clinical trial?
NCT06644261 is sponsored by University of Louisville. The trial plans to enroll 40 participants.