Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 3:26 AM
Study NCT ID:
NCT07356102
Status:
RECRUITING
Last Update Posted:
2026-01-22
First Post:
2026-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Conventional Versus High-Voltage Long-Duration Pulsed Radiofrequency of the Pudendal Nerve
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060545', 'term': 'Pudendal Neuralgia'}], 'ancestors': [{'id': 'D009408', 'term': 'Nerve Compression Syndromes'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009437', 'term': 'Neuralgia'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016568', 'term': 'Drugs, Generic'}], 'ancestors': [{'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 38}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-21', 'studyFirstSubmitDate': '2026-01-11', 'studyFirstSubmitQcDate': '2026-01-11', 'lastUpdatePostDateStruct': {'date': '2026-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Pain Intensity Assessed by Numeric Rating Scale (NRS)', 'timeFrame': 'Baseline, 1 month, 3 months, and 6 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Global Perceived Effect (GPE) Score', 'timeFrame': 'Baseline, 1 month, 3 months, and 6 months', 'description': '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.'}, {'measure': 'Patient Satisfaction Score', 'timeFrame': 'Baseline, 1 month, 3 months, and 6 months', 'description': 'Patient satisfaction with treatment will be assessed using a 5-point satisfaction scale ranging from 0 (not satisfied at all) to 4 (very satisfied).'}, {'measure': 'Quality of Life Assessed by Short Form-36 (SF-36)', 'timeFrame': 'Baseline and 6 months', 'description': 'Health-related quality of life will be evaluated using the Short Form-36 (SF-36) questionnaire.'}, {'measure': 'Adverse Events and Complications', 'timeFrame': 'From intervention to 6 months', 'description': 'All procedure-related adverse events and complications will be recorded throughout the study period.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pudendal Neuralgia', 'Pudendal Nerve', 'Pulsed Radiofrequency', 'PRF', 'Conventional PRF', 'High-Voltage Long-Duration PRF', 'Chronic Pelvic Pain'], 'conditions': ['Pudendal Neuralgia']}, 'descriptionModule': {'briefSummary': '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.\n\nPatients 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.\n\nThe study follows standard clinical procedures and all treatments are performed under sterile conditions with proper monitoring to ensure patient safety.', 'detailedDescription': '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.\n\nEligible 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).\n\nPatients 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Adults aged 18 years or older\n* Diagnosis of pudendal neuralgia according to the Nantes diagnostic criteria\n* Followed at the Algology (Pain Medicine) outpatient clinic\n* Chronic pudendal neuralgia refractory to conservative treatment or intolerance to conservative therapies\n* Not using neuropathic pain medications, or on a stable dose for at least 3 months prior to enrollment\n* Ability to comply with study procedures and follow-up visits\n* Ability to understand the study information and provide written informed consent\n\nExclusion Criteria\n\n* Presence of pelvic organic pathologies that may cause pudendal pain\n* Pain limited only to the coccygeal, gluteal, or lower abdominal regions\n* Patients with purely paroxysmal pain, isolated pruritus, or imaging findings that fully explain symptoms\n* History of malignancy or autoimmune disease\n* Previous surgery that may have altered the anatomy of the pudendal nerve region\n* Pregnancy or suspected pregnancy\n* Presence of a cardiac pacemaker or implanted electrical device\n* Use of anticoagulant therapy or presence of uncorrectable coagulation disorders\n* Active systemic infection or infection at the injection site\n* Known hypersensitivity to metals\n* Inability or unwillingness to provide informed consent'}, 'identificationModule': {'nctId': 'NCT07356102', 'briefTitle': 'Conventional Versus High-Voltage Long-Duration Pulsed Radiofrequency of the Pudendal Nerve', 'organization': {'class': 'OTHER', 'fullName': 'Ankara City Hospital Bilkent'}, 'officialTitle': 'Comparing Conventional and High-Voltage Long-Duration Pulsed Radiofrequency Applied to the Pudendal Nerve in the Treatment of Pudendal Neuralgia: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'E2-25-10056'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1 - Conventional PRF', 'description': '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.', 'interventionNames': ['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']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2 - High-Voltage Long-Duration PRF', 'description': '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.', 'interventionNames': ['Procedure: High-Voltage Long-Duration Pulsed Radiofrequency']}], 'interventions': [{'name': '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', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Arm 1 - Conventional PRF']}, {'name': 'High-Voltage Long-Duration Pulsed Radiofrequency', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Arm 2 - High-Voltage Long-Duration PRF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06800', 'city': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Sukriye Dadali, MD', 'role': 'CONTACT', 'email': 'sukriyedadali@gmail.com', 'phone': '05333316636'}], 'facility': 'Ankara Bilkent City Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Şükriye Dadalı, MD', 'role': 'CONTACT', 'email': 'sukriyedadali@gmail.com', 'phone': '+905333316636'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data are not shared due to institutional and legal restrictions on patient data protection.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara City Hospital Bilkent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Department of Pain Medicine', 'investigatorFullName': 'Şükriye Dadalı', 'investigatorAffiliation': 'Ankara City Hospital Bilkent'}}}}