Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07356102

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

Led by Ankara City Hospital Bilkent · Updated on 2026-01-22

38

Participants Needed

1

Research Sites

92 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye), 06800

Actively Recruiting

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Research Team

Ş

Şükriye Dadalı, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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