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:
Ankara City Hospital Bilkent
Organization:
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: