Conventional Versus High-Voltage Long-Duration Pulsed Radiofrequency of the Pudendal Nerve (NCT07356102) | Clinical Trial Compass
RecruitingNot Applicable
Conventional Versus High-Voltage Long-Duration Pulsed Radiofrequency of the Pudendal Nerve
Turkey (Türkiye)38 participantsStarted 2025-02-19
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Pain Intensity Assessed by Numeric Rating Scale (NRS)
Timeframe: Baseline, 1 month, 3 months, and 6 months