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

RecruitingNot applicableNCT07356102
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

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
Conditions
  • Pudendal Neuralgia
Interventions
  • Procedure: 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
  • Procedure: High-Voltage Long-Duration Pulsed Radiofrequency
Sponsor
Ankara City Hospital Bilkent
Start date
2025-02-19
Primary completion
2026-12
Sex
All
Age range
from 18 Years
Results posted
No results posted in this snapshot
Countries
Turkey (Türkiye)
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07356102