RecruitingNot ApplicableNCT07356102

Conventional Versus High-Voltage Long-Duration Pulsed Radiofrequency of the Pudendal Nerve

Comparing Conventional and High-Voltage Long-Duration Pulsed Radiofrequency Applied to the Pudendal Nerve in the Treatment of Pudendal Neuralgia: A Randomized Controlled Trial


Sponsor

Ankara City Hospital Bilkent

Enrollment

38 participants

Start Date

Feb 19, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a single-center, prospective, randomized controlled trial evaluating two types of pulsed radiofrequency (PRF) treatment for patients with pudendal neuralgia. Pudendal neuralgia is a chronic neuropathic pain affecting the perineum and pelvic area, often causing significant discomfort and reduced quality of life. Patients will be randomly assigned to receive either conventional PRF or high-voltage long-duration PRF applied to the pudendal nerve. The study aims to compare the clinical effectiveness, pain relief, and safety of the two treatment approaches. Participants will be monitored for pain improvement, functional outcomes, and any treatment-related side effects. The study follows standard clinical procedures and all treatments are performed under sterile conditions with proper monitoring to ensure patient safety.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two types of pulsed radiofrequency (PRF) treatments delivered to a nerve called the pudendal nerve for people with chronic pudendal neuralgia — a painful condition causing burning or aching pain in the pelvic area, including around the genitals, perineum, and rectum. Researchers want to see if a higher-voltage, longer-duration version of PRF provides better pain relief than the standard version. **You may be eligible if:** - You are 18 years or older - You have been diagnosed with pudendal neuralgia according to established criteria - Your pain has not improved with conservative treatments (medications, physical therapy, etc.) - You are followed at a pain medicine clinic - You are either not on neuropathic pain medications or have been on a stable dose for at least 3 months **You may NOT be eligible if:** - You have a pelvic organ condition that explains your pain (such as a tumor) - Your pain only affects the buttocks, tailbone, or lower abdomen - You have a pacemaker or other implanted electrical device - You are on blood thinners or have a clotting disorder that cannot be corrected - You have had previous surgery that altered the pudendal nerve anatomy - You are pregnant or may be pregnant - You have a history of cancer or autoimmune disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREIntervention Type * Select the type of intervention. Procedure / Surgery Intervention Name * Enter a brief, descriptive name for the intervention. Use a non-proprietary (generic) name, if available

Conventional pulsed radiofrequency (PRF) is applied to the pudendal nerve at 42°C for 360 seconds, with a pulse frequency of 2 Hz and pulse width of 20 ms. The procedure is performed under sterile conditions in the operating room with patient monitoring (blood pressure, pulse, ECG, oxygen saturation). Patients are positioned prone, the target site is sterilized, and the PRF needle is placed under fluoroscopic guidance. Bilateral symptoms are treated sequentially if present.

PROCEDUREHigh-Voltage Long-Duration Pulsed Radiofrequency

High-voltage long-duration pulsed radiofrequency (PRF) is applied to the pudendal nerve at 42°C for 900 seconds, with a pulse frequency of 2 Hz and pulse width of 20 ms. The voltage is titrated from 40V to a patient-tolerated maximum of 90V. The procedure is performed under sterile conditions in the operating room with patient monitoring (blood pressure, pulse, ECG, oxygen saturation). Patients are positioned prone, the target site is sterilized, and the PRF needle is placed under fluoroscopic guidance. Bilateral symptoms are treated sequentially if present.


Locations(1)

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye)

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NCT07356102


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