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

This study is currently Recruiting

January 2010 By Nantes University Hospital

First Recieved on February 25, 2009

Last Updated on January 4, 2010

Sponsor: Nantes University Hospital
Collaborators:
Information provided by: Nantes University Hospital
Identifier: NCT00851513

Purpose

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 Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Eligibility

Ages Eligible for Study:18 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No
Criteria

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 Lidoca?ne, 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)

Investigators

  • Investigator: Jean-Jacques LABAT - Principal Investigator - CHU de Nantes

Locations

  • Clinique Saint Etienne

    Bayonne, 64100 France

  • CH de la C?te Basque

    Bayonne, 64100 France

  • Centre MARIENIA

    Cambo Les Bains, 64250 France

  • CHU Clermont-Ferrand

    Clermont-Ferrand, 63058 France

  • Hospices Civils de Lyon

    Lyon, 69495 France

  • CHU de Nantes

    Nantes, 44093 France

  • Catherine de Sienne

    Nantes, 44200 France

  • H?pital Rothschild

    Paris, 75571 France

  • H?pital Charles Nicolle

    Rouen, 76031 France

  • Scanner Saint Hilaire

    Rouen, 76000 France

Conditions related to this trial:

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