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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00851513
Recruitment Status : Completed
First Posted : February 26, 2009
Last Update Posted : September 4, 2013
Information provided by:
Nantes University Hospital

Brief Summary:

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

Condition or disease Intervention/treatment Phase
Pudendal Neuralgia Canal Syndrome Drug: Lidocaine Drug: Depmedrol Other: physiological serum Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 202 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : November 2008
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

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

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00851513

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CH de la Côte Basque
Bayonne, France, 64100
Cambo les Bains, France, 64250
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63058
Hospices Civils de Lyon
Lyon, France, 69495
CHU de Nantes
Nantes, France, 44093
Catherine de Sienne
Nantes, France, 44200
Hôpital Rothschild
Paris, France, 75571
Scanner Saint Hilaire
Rouen, France, 76000
Hôpital Charles Nicolle
Rouen, France, 76031
Sponsors and Collaborators
Nantes University Hospital
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Principal Investigator: Jean-Jacques LABAT CHU de Nantes

Layout table for additonal information Identifier: NCT00851513     History of Changes
Other Study ID Numbers: BRD08/6-B
First Posted: February 26, 2009    Key Record Dates
Last Update Posted: September 4, 2013
Last Verified: September 2013
Keywords provided by Nantes University Hospital:
Pudendal neuralgia
pudendal nerve
Alcock's canal syndrome
Canal syndrome
neuropathic pain
randomized protocol
pain scales
Additional relevant MeSH terms:
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Pudendal Neuralgia
Pathologic Processes
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Nerve Compression Syndromes
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action