Pudendal NeuralgiaNCT07356102
Conventional Versus High-Voltage Long-Duration Pulsed Radiofrequency of the Pudendal Nerve
A study testing 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 and High-Voltage Long-Duration Pulsed Radiofrequency in people with Pudendal Neuralgia, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pudendal Neuralgia
- What is being tested?
- 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 and High-Voltage Long-Duration Pulsed Radiofrequency
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Feb 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Bilkent City Hospital
Ankara, 06800
Sukriye Dadali, MD, 05333316636, sukriyedadali@gmail.com
About this study
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
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.
Read the 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.
- Conditions
- Pudendal Neuralgia
- Being tested
- 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, High-Voltage Long-Duration Pulsed Radiofrequency
- Keywords
- Pudendal Neuralgia, Pudendal Nerve, Pulsed Radiofrequency, PRF, Conventional PRF, High-Voltage Long-Duration PRF, Chronic Pelvic Pain
- Medical subject headings
- Pudendal Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 availableProcedure or surgery
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 RadiofrequencyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: High-Voltage Long-Duration Pulsed Radiofrequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1 month, 3 months, and 6 months
Secondary outcomes (4)
Global Perceived Effect (GPE) Score
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.
Measured: Baseline, 1 month, 3 months, and 6 months
Patient Satisfaction Score
Patient satisfaction with treatment will be assessed using a 5-point satisfaction scale ranging from 0 (not satisfied at all) to 4 (very satisfied).
Measured: Baseline, 1 month, 3 months, and 6 months
Quality of Life Assessed by Short Form-36 (SF-36)
Health-related quality of life will be evaluated using the Short Form-36 (SF-36) questionnaire.
Measured: Baseline and 6 months
Adverse Events and Complications
All procedure-related adverse events and complications will be recorded throughout the study period.
Measured: From intervention to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start19 Feb 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pudendal NeuralgiaStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şükriye Dadalı, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07356102
- Sponsor's protocol ID
- E2-25-10056
- Status last verified
- Jan 2026
- First submitted
- 11 Jan 2026
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not shared due to institutional and legal restrictions on patient data protection.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07356102
- Acronym / sponsor ID
- E2-25-10056
- Conditions
- Pudendal Neuralgia
- Keywords
- Pudendal Neuralgia, Pudendal Nerve, Pulsed Radiofrequency, PRF, Conventional PRF, High-Voltage Long-Duration PRF, Chronic Pelvic Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 19 Feb 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Conventional PRF | Experimental | 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 availableConventional 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. |
| Arm 2 - High-Voltage Long-Duration PRF | Experimental | Procedure: High-Voltage Long-Duration Pulsed RadiofrequencyHigh-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 availableConventional 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. | Procedure or surgery | Arm 1 - Conventional PRF |
| High-Voltage Long-Duration Pulsed RadiofrequencyHigh-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. | Procedure or surgery | Arm 2 - High-Voltage Long-Duration PRF |
Primary outcome
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.
4 secondary outcomes
Global Perceived Effect (GPE) Score
Time frame: Baseline, 1 month, 3 months, and 6 months
Patient Satisfaction Score
Time frame: Baseline, 1 month, 3 months, and 6 months
Quality of Life Assessed by Short Form-36 (SF-36)
Time frame: Baseline and 6 months
Adverse Events and Complications
Time frame: From intervention to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: No. Individual participant data are not shared due to institutional and legal restrictions on patient data protection.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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 and High-Voltage Long-Duration Pulsed Radiofrequency in people with Pudendal Neuralgia, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Şükriye Dadalı, MD (+905333316636, sukriyedadali@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Intensity Assessed by Numeric Rating Scale (NRS) (time frame: Baseline, 1 month, 3 months, and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.