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Recruiting NCT07356102

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

Trial Parameters

Condition Pudendal Neuralgia
Sponsor Ankara City Hospital Bilkent
Study Type INTERVENTIONAL
Phase N/A
Enrollment 38
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-02-19
Completion 2026-12
Interventions
Intervention 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 availableHigh-Voltage Long-Duration Pulsed Radiofrequency

Brief 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 Criteria

Inclusion Criteria * Adults aged 18 years or older * Diagnosis of pudendal neuralgia according to the Nantes diagnostic criteria * Followed at the Algology (Pain Medicine) outpatient clinic * Chronic pudendal neuralgia refractory to conservative treatment or intolerance to conservative therapies * Not using neuropathic pain medications, or on a stable dose for at least 3 months prior to enrollment * Ability to comply with study procedures and follow-up visits * Ability to understand the study information and provide written informed consent Exclusion Criteria * Presence of pelvic organic pathologies that may cause pudendal pain * Pain limited only to the coccygeal, gluteal, or lower abdominal regions * Patients with purely paroxysmal pain, isolated pruritus, or imaging findings that fully explain symptoms * History of malignancy or autoimmune disease * Previous surgery that may have altered the anatomy of the pudendal nerve region * Pregnancy or suspected pregnancy * Presence of a card

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