Conventional vs High-Voltage Long-Duration Pulsed Radiofrequency for pudendal nerve pain
Official title: Comparing Conventional and High-Voltage Long-Duration Pulsed Radiofrequency Applied to the Pudendal Nerve in the Treatment of Pudendal Neuralgia: A Randomized Controlled Trial
Run by Ankara City Hospital Bilkent · NCT07356102 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 38 (estimated) |
| Sponsor | Ankara City Hospital Bilkent Academic / other |
| Locations | 1 site (Ankara) |
| Status | Recruiting |
| Started | February 19, 2025 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | January 22, 2026 |
| Trial ID | NCT07356102 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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Ankara Bilkent City Hospital
Ankara, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: Şükriye Dadalı, MD
- Email: sukriyedadali@gmail.com
- Phone: +905333316636
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Evaluating nerve injections for treating pudendal neuralgia pain
This study is testing if injections of lidocaine into the pudendal nerve can help adults with pudendal neuralgia pain who haven't found relief from regular medications.
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Program to improve nerve healing after laparoscopic surgery for chronic pelvic pain
This study is testing a robot-assisted surgery to see if it can help people with chronic pelvic pain from nerve issues feel better and heal more effectively after other treatments haven't worked.
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Comparing two methods for pudendal nerve block in pelvic pain treatment
This study is testing two different ways to give a nerve block to see which one helps women with pelvic pain feel better.
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Robot-assisted surgery for nerve entrapment pain relief
This study is testing if robot-assisted surgery can help people with chronic pelvic pain caused by nerve entrapment feel better when other treatments haven't worked.
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Using closed-loop spinal cord stimulation to treat chronic pelvic pain
This study is testing a new spinal cord stimulation treatment to see if it can help people with chronic pelvic pain feel better and improve their quality of life.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.