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

NCT07356102 · tracked via the Priya Life Science Turkey tracker

Sponsor

Ankara City Hospital Bilkent

Phase

Not applicable

Started

2025-02-19

Last updated

2026-01-22

Condition(s) studied

Pudendal Neuralgia

Investigational drug(s) / intervention(s)

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

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 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.

High-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.

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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 cardiac pacemaker or implanted electrical device * Use of anticoagulant therapy or presence of uncorrectable coagulation disorders * Active systemic infection or infection at the injection site * Known hypersensitivity to metals * Inability or unwillingness to provide informed consent

Primary outcome measure(s)

Change in Pain Intensity Assessed by Numeric Rating Scale (NRS) — Baseline, 1 month, 3 months, and 6 months
Pain intensity will be assessed using the Numeric Rating Scale (NRS), which ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. The primary outcome is the change in NRS score from baseline to 6 months after treatment. Higher scores indicate greater pain intensity. NRS scores will also be recorded at 1 and 3 months to allow longitudinal comparison.

Trial sites (1)

Facility	City	Region	Status
Ankara Bilkent City Hospital	Ankara	Turkey (Türkiye)	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07356102 on ClinicalTrials.gov ↗ ← All trials in Turkey