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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Turkey
Ankara Bilkent City Hospital
RECRUITING
Ankara
Contact Information
Primary
Şükriye Dadalı, MD
sukriyedadali@gmail.com
+905333316636
Time Frame
Start Date: 2025-02-19
Estimated Completion Date: 2026-12
Participants
Target number of participants: 38
Treatments
Experimental: Arm 1 - Conventional PRF
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.
Experimental: Arm 2 - High-Voltage Long-Duration PRF
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.
Related Therapeutic Areas
Sponsors
Leads: Ankara City Hospital Bilkent

This content was sourced from clinicaltrials.gov