Evaluation of the Efficacy of Therapeutic Infiltrations of the Pudendal Nerve, Performed Under Ne… (NCT06872437) | Clinical Trial Compass
RecruitingPhase 3
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.
France60 participantsStarted 2023-12-08
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
Timeframe: between inclusion and 1 month after the first injection.