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NCT Number: NCT07356102

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Bilkent City Hospital

Ankara, 06800, Turkey (Türkiye)

Location status: Recruiting

Location contact

Sukriye Dadali, MD

CONTACT

[email protected]

05333316636

About this study

This single-center, prospective, randomized controlled trial aims to compare the clinical effectiveness and safety of conventional pulsed radiofrequency (PRF) versus high-voltage long-duration PRF applied to the pudendal nerve in patients with pudendal neuralgia.

Eligible patients will be randomly assigned to one of the two intervention groups. Conventional PRF will be applied at 42°C for 360 seconds, while high-voltage long-duration PRF will be applied at 42°C for up to 900 seconds, with voltage titrated from 40V to a patient-tolerated maximum of 90V. All procedures are performed under sterile conditions in an operating room with patient monitoring (blood pressure, pulse, ECG, and oxygen saturation).

Patients will be assessed for pain intensity, functional improvement, and adverse effects at scheduled follow-up visits. Bilateral symptoms will be treated sequentially if present. The study adheres to standard clinical safety procedures and no additional risk beyond routine clinical care is anticipated.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: Baseline, 1 month, 3 months, and 6 months

    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.

Secondary outcomes

  1. Global Perceived Effect (GPE) Score

    Time frame: Baseline, 1 month, 3 months, and 6 months

    Patient-reported global improvement will be assessed using the Global Perceived Effect (GPE) scale, a Likert-type scale ranging from -5 to +5, where negative values indicate worsening, 0 indicates no change, and positive values indicate improvement. Higher scores indicate a better perceived outcome.

  2. Patient Satisfaction Score

    Time frame: Baseline, 1 month, 3 months, and 6 months

    Patient satisfaction with treatment will be assessed using a 5-point satisfaction scale ranging from 0 (not satisfied at all) to 4 (very satisfied).

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

    Time frame: Baseline and 6 months

    Health-related quality of life will be evaluated using the Short Form-36 (SF-36) questionnaire.

  4. Adverse Events and Complications

    Time frame: From intervention to 6 months

    All procedure-related adverse events and complications will be recorded throughout the study period.

Study contacts

Contact information is provided by the study sponsor or research team.

Şükriye Dadalı, MD

CONTACT

[email protected]

+905333316636

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 21, 2026
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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