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
Phase 3
Interventional Study
Pudendal Neuralgia
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 60 (estimated)
- Sponsor
- Groupe Hospitalier Diaconesses Croix Saint-Simon · Other
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About This Trial
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…
Trial Locations
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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 treatmen…
Contacts
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