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Tests treatment safety and results for Pudendal Neuralgia
Official title 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.
ClinicalTrials.gov ID: NCT06872437
What this study is testing
What is Lidocaine Injectable Solution?
Lidocaine Injectable Solution is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for pudendal neuralgia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Pudendal neuralgia (PN) is a chronic nerve compression syndrome causing neuropathic pain. Treatment includes medication, infiltration and decompressive surgery.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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
You likely can't join 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
See the full eligibility 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Paris, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.