Pudendal NeuralgiaPhase 3EPHI-DACINCT06872437
Evaluation of the Efficacy of Therapeutic Infiltrations of the Pudendal Nerve, Performed Under Neurostimulation on Pain, 1 Month After an Infiltration of Local Anaesthetic, in the Treatment of Pudendal Neuralgia.
A Phase 3 study testing Lidocaine Injectable Solution and Saline Solution for Block in people with Pudendal Neuralgia, run by Groupe Hospitalier Diaconesses Croix Saint-Simon at 1 site in France.
Trial summary
Pudendal neuralgia (PN) is a chronic nerve compression syndrome causing neuropathic pain. Treatment includes medication, infiltration and decompressive surgery. Medicinal treatment involves the use of drugs that have proved effective in other areas, such as shingles or diabetes. 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?
- Lidocaine Injectable Solution and Saline Solution for Block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 8 Dec 2023to 8 Mar 2029
- Phase
- Phase 3
- 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
- Patient 18 years of age or older,
- Expressed consent to participate in the study
- Affiliated or beneficiary of a social security plan
- With pudendal neuralgia (Nantes criteria "modified" Nantes criteria).
- MRI normal or without pathology explaining the pain
- Drug treatment failure as defined in the LOS, i.e., failure (VAS decrease < 3) of at least one antiepileptic drug and an antidepressant whose dosages have been to the maximum possible dosage, or in whom a side effect for whom a side effect could not allow the dose to be increased to its to its maximum allowed dose.
Who cannot join
- Patient benefiting from a legal protection measure
- Pregnant or breastfeeding woman
- General and/or local infection (fistulous or cutaneous suppuration of the anal margin) in progress
- Known neurological pathology that may explain the pain
- Psychiatric pathology requiring a drug treatment treatment
- Anticoagulants or haemostasis disorders
- Hypersensitivity to lidocaine hydrochloride, to local anesthetics
- Recurrent porphyrias
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Croix Saint-Simon
Paris, 75020
Rahma MKHININI, Clinical Research Assistant, +33 01 44 64 30 95, rmkhinini@hopital-dcss.org
Axel EGAL, Doctor
About this study
Official title: EFFICACY OF THE USUAL TREATMENT WITH INFILTRATION OF LOCAL ANAESTHETIC IN THE TREATMENT OF PUDENDAL NEURALGIA: A RANDOMISED TRIAL COMPARED WITH A PHYSIOLOGICAL SERUM
Pudendal neuralgia (PN) is a chronic nerve compression syndrome causing neuropathic pain. Treatment includes medication, infiltration and decompressive surgery. Medicinal treatment involves the use of drugs that have proved effective in other areas, such as shingles or diabetes. There is no consensus on the molecules to be used for pudendal nerve infiltration (PNTI), and less than half of patients experience short-term relief. The only risk factor for failure is the duration of pain. Our study proposes to compare the usual treatment with a placebo, as no type of infiltration has been compared with a placebo.
Read the detailed description
Like carpal tunnel syndrome, pudendal neuralgia (PN) is defined as a syndrome of chronic nerve compression (of the pudendal nerve) causing neuropathic pain.
Treatment of NP is based on 3 therapeutic strategies of increasing aggressiveness: drug treatment, infiltrations and decompressive surgery.
Drug treatment is based on the "empirical" use of drugs for neuropathic pain that have proved effective in other areas (shingles, diabetes, etc.). People with this disease are generally considered 'non-responders' to drug treatment after failure (decrease in VAS scale < 3) of at least one antidepressant and one antiepileptic drug, whose doses have been increased to the maximum possible level, or in whom a side effect has prevented the dose from being increased to the maximum authorised level.
For pudendal nerve infiltration (ITNP), there is no consensus or recommendation on which molecules to use. Most studies have used a combination of local anaesthetics and corticosteroids. However, a randomised controlled trial, researchers compare lidocaine infiltration with or without methylprednisolone. The results were not significantly different (14% vs 11%).
According to the data in the literature, less than half of patients (11% to 39%) are relieved in the short term, up to 3 months, and only about 10% (6.8% to 12.2%) are still relieved at 1 year. The only recognised risk factor for failure seems to be the duration of pain (more than 1 year). Other risk factors have been described in the literature, but only in one study and not in the others, such as gender (male or female), age (over or under 70), duration of pain (over or under 1 year), and whether the pain is bilateral or not.
In our department, patients are currently treated with lidocaine INTP under neurostimulation. Given the poor results in terms of efficacy and the strong psychological component in chronic pain pathologies, the investigators propose in this study to compare our usual treatment with placebo, since no type of infiltration has ever been compared with placebo, although this is a condition where the placebo effect is likely to be large.
- Conditions
- Pudendal Neuralgia
- Being tested
- Lidocaine Injectable Solution, Saline Solution for Block
- Medical subject headings
- Pudendal Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine Injectable SolutionDrug
Infiltration by injections of 6mL of lidocaine (10 mg/mL) per injection site (left ischioanal fossa, right ischioanal fossa right ischioanal fossa, coccyx),
Saline Solution for BlockDrug
Infiltration by injections of 6mL of saline solution per injection site (left ischio-anal fossa, right ischio-anal fossa right ischio-anal fossa, coccyx)
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine | Active comparator | Infiltration by injections of 6mL of lidocaine (10 mg/mL) per injection site (left ischioanal fossa, right ischioanal fossa right ischioanal fossa, coccyx) Receives: Drug: Lidocaine Injectable Solution |
| Saline solution | Placebo comparator | Infiltration by injections of 6mL of saline solution per injection site (left ischio-anal fossa, right ischio-anal fossa right ischio-anal fossa, coccyx) Receives: Drug: Saline Solution for Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between the two treatment arms (lidocaine vs.saline) of the rate of patients with a decrease of at least 3 points on a visual 3 points on a visual analogue pain scale (VAS) between inclusion and
Measured: between inclusion and 1 month after the first injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start8 Dec 2023
- Primary completion8 Mar 2029 (estimated)
- Study completion8 Mar 2029 (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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier Diaconesses Croix Saint-Simon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Axel EGAL, Doctor, Principal investigator, Groupe Hospitalier Diaconesses Croix Saint-Simon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06872437
- Sponsor's protocol ID
- RI-B-2021-7300-07
- Acronym
- EPHI-DACI
- Status last verified
- May 2025
- First submitted
- 29 Apr 2021
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFICACY OF THE USUAL TREATMENT WITH INFILTRATION OF LOCAL ANAESTHETIC IN THE TREATMENT OF PUDENDAL NEURALGIA: A RANDOMISED TRIAL COMPARED WITH A PHYSIOLOGICAL SERUM
- ClinicalTrials.gov ID
- NCT06872437
- Acronym / sponsor ID
- EPHI-DACI / RI-B-2021-7300-07
- Conditions
- Pudendal Neuralgia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Groupe Hospitalier Diaconesses Croix Saint-SimonUniversity, hospital or other
- Study start
- 8 Dec 2023 (actual)
- Primary completion
- 8 Mar 2029 (estimated)
- Study completion
- 8 Mar 2029 (estimated)
- First posted
- 12 Mar 2025 (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.
Pudendal neuralgia (PN) is a chronic nerve compression syndrome causing neuropathic pain. Treatment includes medication, infiltration and decompressive surgery. Medicinal treatment involves the use of drugs that have proved effective in other areas, such as shingles or diabetes. There is no consensus on the molecules to be used for pudendal nerve infiltration (PNTI), and less than half of patients experience short-term relief. The only risk factor for failure is the duration of pain. Our study proposes to compare the usual treatment with a placebo, as no type of infiltration has been compared with a placebo.
Detailed description
Like carpal tunnel syndrome, pudendal neuralgia (PN) is defined as a syndrome of chronic nerve compression (of the pudendal nerve) causing neuropathic pain.
Treatment of NP is based on 3 therapeutic strategies of increasing aggressiveness: drug treatment, infiltrations and decompressive surgery.
Drug treatment is based on the "empirical" use of drugs for neuropathic pain that have proved effective in other areas (shingles, diabetes, etc.). People with this disease are generally considered 'non-responders' to drug treatment after failure (decrease in VAS scale < 3) of at least one antidepressant and one antiepileptic drug, whose doses have been increased to the maximum possible level, or in whom a side effect has prevented the dose from being increased to the maximum authorised level.
For pudendal nerve infiltration (ITNP), there is no consensus or recommendation on which molecules to use. Most studies have used a combination of local anaesthetics and corticosteroids. However, a randomised controlled trial, researchers compare lidocaine infiltration with or without methylprednisolone. The results were not significantly different (14% vs 11%).
According to the data in the literature, less than half of patients (11% to 39%) are relieved in the short term, up to 3 months, and only about 10% (6.8% to 12.2%) are still relieved at 1 year. The only recognised risk factor for failure seems to be the duration of pain (more than 1 year). Other risk factors have been described in the literature, but only in one study and not in the others, such as gender (male or female), age (over or under 70), duration of pain (over or under 1 year), and whether the pain is bilateral or not.
In our department, patients are currently treated with lidocaine INTP under neurostimulation. Given the poor results in terms of efficacy and the strong psychological component in chronic pain pathologies, the investigators propose in this study to compare our usual treatment with placebo, since no type of infiltration has ever been compared with placebo, although this is a condition where the placebo effect is likely to be large.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine | Active comparator | Drug: Lidocaine Injectable SolutionInfiltration by injections of 6mL of lidocaine (10 mg/mL) per injection site (left ischioanal fossa, right ischioanal fossa right ischioanal fossa, coccyx) |
| Saline solution | Placebo comparator | Drug: Saline Solution for BlockInfiltration by injections of 6mL of saline solution per injection site (left ischio-anal fossa, right ischio-anal fossa right ischio-anal fossa, coccyx) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient 18 years of age or older,
- Expressed consent to participate in the study
- Affiliated or beneficiary of a social security plan
- With pudendal neuralgia (Nantes criteria "modified" Nantes criteria).
- MRI normal or without pathology explaining the pain
Key exclusion criteria (8 listed)
- Patient benefiting from a legal protection measure
- Pregnant or breastfeeding woman
- General and/or local infection (fistulous or cutaneous suppuration of the anal margin) in progress
- Known neurological pathology that may explain the pain
- Psychiatric pathology requiring a drug treatment treatment
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 |
|---|---|---|
| Lidocaine Injectable SolutionInfiltration by injections of 6mL of lidocaine (10 mg/mL) per injection site (left ischioanal fossa, right ischioanal fossa right ischioanal fossa, coccyx), | Drug | Lidocaine |
| Saline Solution for BlockInfiltration by injections of 6mL of saline solution per injection site (left ischio-anal fossa, right ischio-anal fossa right ischio-anal fossa, coccyx) | Drug | Saline solution |
Primary outcome
Comparison between the two treatment arms (lidocaine vs.saline) of the rate of patients with a decrease of at least 3 points on a visual 3 points on a visual analogue pain scale (VAS) between inclusion and
Time frame: between inclusion and 1 month after the first injection.
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 18 May 2025.
- Individual participant dataSharing planned: No
Related trials for Pudendal Neuralgia
Active, not recruiting
Positioning for Hip Arthroscopic Surgery to Reduce Postoperative Numbness
Hip Osteoarthritis, Hip Injuries
Active, not recruiting
Pudendal Nerve Block With Articaine and Triamcinolone for Pudendal Neuralgia
Pudendal Neuralgia Pudendal Nerve Entrapment Chronic Pelvic Pain
RecruitingObservational study
Decompression of Pudendal and Inferior Cluneal Nerves Using Robot-assisted Laparoscopy for Entrapment Neuralgias : the X-DECO Study
Pudendal Neuralgia
Recruiting
Conventional Versus High-Voltage Long-Duration Pulsed Radiofrequency of the Pudendal Nerve
Pudendal Neuralgia
RecruitingObservational study
Perioperative Medical Program to Optimize Nerve Regeneration After Robot-assisted Laparoscopic Neurolyses of Pudendal and/or Inferior Cluneal Nerves for Chronic Neuralgias: Results After 1-year Follow-up
Pudendal Neuralgia, Neuralgia
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.
Axel EGAL, Doctor principal investigator
Groupe Hospitalier Diaconesses Croix Saint-Simon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lidocaine Injectable Solution and Saline Solution for Block in people with Pudendal Neuralgia, run by Groupe Hospitalier Diaconesses Croix Saint-Simon at 1 site in France.
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 6 inclusion and 8 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 18 May 2025. 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 France. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison between the two treatment arms (lidocaine vs.saline) of the rate of patients with a decrease of at least 3 points on a visual 3 points on a visual analogue pain scale (VAS) between inclusion and (time frame: between inclusion and 1 month after the first injection.). 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 18 May 2025.