Therapeutic Effects Analysis of Pudendal Nerve Infiltrations After 3 Months, in Patients Suffering of Pudendal Neuralgia (INFILTHERA)

Pudendal neuralgia is a recent identified pathology, extremely invalidating, related to chronic pelvic entrapment. Nowadays, pudendal neuralgia can be treated with:

• neuropathic pains treatment
• specific kinesitherapy
• Alcock's canal and sacrospinal ligament infiltrations under scan
• with diagnostic block
• local steroids injections
• and surgical decompression of pudendal nerve with transrectal approach.

Only surgery was validated after a randomised protocol studying surgery versus abstention, performed and published by the CHU de Nantes. Many techniques have been proposed for realization of pudendal nerve infiltrations. The results of these infiltrations have never been published, and no randomised study had ever evaluated those results, even at short-run. Very few randomized studies have validated steroids infiltrations techniques in canal syndrome neuropathies.

The primary objective of the investigators phase IV trial is to evaluate the efficacy of three different types of pudendal nerve infiltrations in Alcock's canal and sacrospinal ligament:

• group A: only local anesthetic (control arm)
• group B: local anesthetics associated with local steroids
• group C: local anesthetics associated with local steroids and important volumes of physiological serum

Study Overview

• Status: Completed
• Conditions: Pudendal Neuralgia; Canal Syndrome
• Intervention / Treatment: Drug: Lidocaine; Drug: Depmedrol; Other: physiological serum

• Study Type: Interventional
• Enrollment (Actual): 202
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Bayonne, France, 64100
    • CH de la Cote Basque
  • Cambo les Bains, France, 64250
    • Centre MARIENIA
  • Clermont-Ferrand, France, 63058
    • CHU Clermont-Ferrand
  • Lyon, France, 69495
    • Hospices Civils de Lyon
  • Nantes, France, 44093
    • CHU de Nantes
  • Nantes, France, 44200
    • Catherine de Sienne
  • Paris, France, 75571
    • Hôpital Rothschild
  • Rouen, France, 76031
    • Hopital Charles Nicolle
  • Rouen, France, 76000
    • Scanner Saint Hilaire

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient presenting the four indispensable clinical criteria for pudendal neuralgia (Nantes' criteria)
• Man or woman aged more than 18 years old
• Suffering from pudendal neuralgia since more than six months
• Without previous infiltration identical to the one proposed by the protocol
• Without previous surgery of pudendal nerve
• Without any hemorrhagic risk factor
• No contra-indication to Lidocaïne, Depo-medrol or contrast-product injections
• Pain intensity with an average > or = 40/100 (measured by scales during the fifteen days before infiltration)

Exclusion Criteria:

• Patient presenting one of the four exclusion clinical criterium for pudendal neuralgia (Nantes' criteria)
• Patient who has filled his "pain note book" during less than 5 days over the 15 days before the infiltration
• Pregnancy
• Depression (Beck scale > 16/39)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group B; local anesthetics (lidocaine) associated with local steroids (depo-medrol)	Drug: Lidocaine; local anesthetics; Drug: Depmedrol; local steroids
Experimental: Group C; local anesthetics (lidocaine) associated with local steroids (depomedrol) and important volumes of physiological serum	Drug: Lidocaine; local anesthetics; Drug: Depmedrol; local steroids; Other: physiological serum; important volumes of physiological serum
Active Comparator: Group A; only local anesthetic (lidocaine)	Drug: Lidocaine; local anesthetics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The main objective is to evaluate, after 3 months, the therapeutical efficacy on pain of steroids pudendal nerve infiltration, in patients suffering from pudendal neuralgia with canal syndrome

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Principal Investigator: Jean-Jacques LABAT, CHU de Nantes

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: February 25, 2009
• First Submitted That Met QC Criteria: February 25, 2009
• First Posted (Estimate): February 26, 2009

Study Record Updates

• Last Update Posted (Estimate): September 4, 2013
• Last Update Submitted That Met QC Criteria: September 2, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: neuropathic pain; infiltration; pudendal nerve; pain scales; Pudendal neuralgia; Alcock's canal syndrome; Canal syndrome; randomized protocol
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Pain; Neurologic Manifestations; Disease; Neuromuscular Diseases; Peripheral Nervous System Diseases; Nerve Compression Syndromes; Syndrome; Neuralgia; Pudendal Neuralgia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: BRD08/6-B