NCT06872437 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.
| NCT ID | NCT06872437 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Groupe Hospitalier Diaconesses Croix Saint-Simon |
| Condition | Pudendal Neuralgia |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-12-08 |
| Primary Completion | 2029-03-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 60 participants in total. It began in 2023-12-08 with a primary completion date of 2029-03-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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
Contact & Investigator
Axel EGAL, Doctor
PRINCIPAL INVESTIGATOR
Groupe Hospitalier Diaconesses Croix Saint-Simon
Frequently Asked Questions
Who can join the NCT06872437 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pudendal Neuralgia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06872437 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 60 participants.
Is NCT06872437 currently recruiting?
Yes, NCT06872437 is actively recruiting participants. Visit ClinicalTrials.gov or contact Groupe Hospitalier Diaconesses Croix Saint-Simon to inquire about joining.
Where is the NCT06872437 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT06872437 clinical trial?
NCT06872437 is sponsored by Groupe Hospitalier Diaconesses Croix Saint-Simon. The principal investigator is Axel EGAL, Doctor at Groupe Hospitalier Diaconesses Croix Saint-Simon. The trial plans to enroll 60 participants.