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

NCT07356102 | Recruiting

• 1 other identifier: E2-25-10056
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pudendal Neuralgia

Keywords

Pudendal Neuralgia; Pudendal Nerve; Pulsed Radiofrequency; PRF; Conventional PRF; High-Voltage Long-Duration PRF; Chronic Pelvic Pain

Outcome Measures

Primary Outcomes (1)

• Change in Pain Intensity Assessed by Numeric Rating Scale (NRS)

  Pain intensity will be assessed using the Numeric Rating Scale (NRS), which ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. The primary outcome is the change in NRS score from baseline to 6 months after treatment. Higher scores indicate greater pain intensity. NRS scores will also be recorded at 1 and 3 months to allow longitudinal comparison.

  Baseline, 1 month, 3 months, and 6 months

Secondary Outcomes (4)

• Global Perceived Effect (GPE) Score

  Baseline, 1 month, 3 months, and 6 months

• Patient Satisfaction Score

  Baseline, 1 month, 3 months, and 6 months

• Quality of Life Assessed by Short Form-36 (SF-36)

  Baseline and 6 months

• Adverse Events and Complications

  From intervention to 6 months

Study Arms (2)

Arm 1 - Conventional PRF

EXPERIMENTAL

Conventional Pulsed Radiofrequency Description: Conventional PRF applied to the pudendal nerve at 42°C for 360 seconds, 2 Hz, 20 ms pulse width. Standard clinical procedure under sterile conditions.

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

Arm 2 - High-Voltage Long-Duration PRF

EXPERIMENTAL

High-Voltage Long-Duration Pulsed Radiofrequency Description: High-voltage, long-duration PRF applied to the pudendal nerve at 42°C for 900 seconds, voltage titrated from 40V to patient-tolerated maximum of 90V. Procedure performed under sterile conditions.

Procedure: High-Voltage Long-Duration Pulsed Radiofrequency

Interventions

High-Voltage Long-Duration Pulsed Radiofrequency PROCEDURE

High-voltage long-duration pulsed radiofrequency (PRF) is applied to the pudendal nerve at 42°C for 900 seconds, with a pulse frequency of 2 Hz and pulse width of 20 ms. The voltage is titrated from 40V to a patient-tolerated maximum of 90V. The procedure is performed under sterile conditions in the operating room with patient monitoring (blood pressure, pulse, ECG, oxygen saturation). Patients are positioned prone, the target site is sterilized, and the PRF needle is placed under fluoroscopic guidance. Bilateral symptoms are treated sequentially if present.

Arm 2 - High-Voltage Long-Duration PRF

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

Conventional pulsed radiofrequency (PRF) is applied to the pudendal nerve at 42°C for 360 seconds, with a pulse frequency of 2 Hz and pulse width of 20 ms. The procedure is performed under sterile conditions in the operating room with patient monitoring (blood pressure, pulse, ECG, oxygen saturation). Patients are positioned prone, the target site is sterilized, and the PRF needle is placed under fluoroscopic guidance. Bilateral symptoms are treated sequentially if present.

Arm 1 - Conventional PRF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, 06800, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pudendal Neuralgia

Interventions

Drugs, Generic

Condition Hierarchy (Ancestors)

Nerve Compression Syndromes; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Central Study Contacts

Şükriye Dadalı, MD

CONTACT

+905333316636; sukriyedadali@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Department of Pain Medicine

Model Details: Participants will be randomly assigned to one of two parallel groups. One group will receive conventional pulsed radiofrequency (PRF) of the pudendal nerve, and the other group will receive high-voltage long-duration PRF. Each participant will receive only one type of intervention.

Study Record Dates

• First Submitted: January 11, 2026
• First Posted: January 21, 2026
• Study Start: February 19, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)