Conventional vs High-Voltage Long-Duration Pulsed Radiofrequency for pudendal nerve pain

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

This trial will try two pulsed radiofrequency approaches to see which one relieves pudendal nerve pain better for adults whose pain hasn't improved with standard treatments.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 38 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ankara City Hospital Bilkent (other)
• Locations: 1 site (Ankara)
• Trial ID: NCT07356102 on ClinicalTrials.gov

What this trial studies

This single-center, prospective, randomized controlled trial compares conventional pulsed radiofrequency (PRF) with high-voltage long-duration PRF applied to the pudendal nerve in adults with pudendal neuralgia. Participants are randomly assigned to conventional PRF (42°C for 360 seconds) or high-voltage long-duration PRF (42°C for up to 900 seconds with voltage titrated between 40–90V as tolerated). Procedures are done under sterile conditions in an operating room with standard monitoring, and bilateral symptoms are treated sequentially when present. Outcomes include pain intensity, functional measures, and treatment-related adverse effects at scheduled follow-up visits.

Who should consider this trial

Good fit: Adults (≥18 years) diagnosed with pudendal neuralgia by the Nantes criteria who have persistent symptoms despite conservative treatment, are on stable neuropathic medication doses or not taking them, and can provide informed consent and attend follow-up visits.

Not a fit: Patients with pelvic structural causes of pain, pain limited only to the coccyx/gluteal/lower abdominal areas, purely paroxysmal symptoms, prior pelvic surgery that altered pudendal anatomy, or who are pregnant are unlikely to benefit from the interventions tested.

Why it matters

Potential benefit: If successful, the high-voltage long-duration approach could provide stronger or longer-lasting pain relief with an acceptable safety profile, improving daily function and quality of life.

How similar studies have performed: Small studies of conventional PRF for neuropathic pelvic pain have shown mixed but sometimes positive results, while high-voltage long-duration PRF is less well studied and remains relatively novel.

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 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

Where this trial is running

Ankara

• Ankara Bilkent City Hospital — Ankara, Turkey (Türkiye) (RECRUITING)

Study contacts

• Study coordinator: Şükriye Dadalı, MD

Conditions: Pudendal Neuralgia, Pudendal Nerve, Pulsed Radiofrequency, PRF, Conventional PRF, High-Voltage Long-Duration PRF, Chronic Pelvic Pain