Actively Recruiting
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.
Led by Groupe Hospitalier Diaconesses Croix Saint-Simon · Updated on 2025-05-18
60
Participants Needed
1
Research Sites
273 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient 18 years of age or older
- Provided consent to participate in the study
- Affiliated with or beneficiary of a social security plan
- Diagnosed with pudendal neuralgia using modified Nantes criteria
- MRI results normal or show no cause for the pain
- Failed drug treatment defined as less than 3-point pain decrease on VAS after maximum doses of at least one antiepileptic and one antidepressant, or unable to increase dose due to side effects
You will not qualify if you...
- Under legal protection measures
- Pregnant or breastfeeding
- Active general or local infection, including anal margin suppuration
- Known neurological disease explaining the pain
- Psychiatric illness requiring drug treatment
- Use of anticoagulants or bleeding disorders
- Allergic to lidocaine or other local anesthetics
- Recurrent porphyrias
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hôpital Croix Saint-Simon
Paris, France, 75020
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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