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.
Recruiting now · Phase 3
Conditions studied: Pudendal Neuralgia
In brief
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.
Key facts
- Study ID
- NCT06872437
- Run by
- Groupe Hospitalier Diaconesses Croix Saint-Simon
- People needed
- 60
- Starts
- 2023-12-08
- Expected to finish
- 2029-03-08
- Last updated by the study team
- 2025-05-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Hôpital Croix Saint-Simon — Paris, France (enrolling)
Full record on ClinicalTrials.gov
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