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.

NCT06872437 | Recruiting Phase 3

• 1 other identifier: RI-B-2021-7300-07
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pudendal Neuralgia

Outcome Measures

Primary Outcomes (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

  between inclusion and 1 month after the first injection.

Study Arms (2)

Lidocaine

ACTIVE COMPARATOR

Infiltration by injections of 6mL of lidocaine (10 mg/mL) per injection site (left ischioanal fossa, right ischioanal fossa right ischioanal fossa, coccyx)

Drug: Lidocaine Injectable Solution

Saline solution

PLACEBO COMPARATOR

Infiltration by injections of 6mL of saline solution per injection site (left ischio-anal fossa, right ischio-anal fossa right ischio-anal fossa, coccyx)

Drug: Saline Solution for Block

Interventions

Lidocaine Injectable Solution DRUG

Infiltration by injections of 6mL of lidocaine (10 mg/mL) per injection site (left ischioanal fossa, right ischioanal fossa right ischioanal fossa, coccyx),

Lidocaine

Saline Solution for Block DRUG

Infiltration by injections of 6mL of saline solution per injection site (left ischio-anal fossa, right ischio-anal fossa right ischio-anal fossa, coccyx)

Saline solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Groupe Hospitalier Diaconesses Croix Saint-Simon: lead

Study Sites (1)

Hôpital Croix Saint-Simon

Paris, 75020, France

RECRUITING

MeSH Terms

Conditions

Pudendal Neuralgia

Interventions

Saline Solution; Dental Occlusion

Condition Hierarchy (Ancestors)

Nerve Compression Syndromes; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Axel EGAL, Doctor

  Groupe Hospitalier Diaconesses Croix Saint-Simon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: March 12, 2025
• Study Start: December 8, 2023
• Primary Completion (Estimated): March 8, 2029
• Study Completion (Estimated): March 8, 2029
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)