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

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ClinicalTrials.gov Identifier: NCT00851513
Recruitment Status : Completed
First Posted : February 26, 2009
Last Update Posted : September 4, 2013
Sponsor:
Information provided by:
Nantes University Hospital

Tracking Information
First Submitted Date  ICMJE February 25, 2009
First Posted Date  ICMJE February 26, 2009
Last Update Posted Date September 4, 2013
Study Start Date  ICMJE November 2008
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2009)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00851513 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Therapeutic Effects Analysis of Pudendal Nerve Infiltrations After 3 Months, in Patients Suffering of Pudendal Neuralgia
Official Title  ICMJE Not Provided
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Pudendal Neuralgia
  • Canal Syndrome
Intervention  ICMJE
  • Drug: Lidocaine
    local anesthetics
  • Drug: Depmedrol
    local steroids
  • Other: physiological serum
    important volumes of physiological serum
Study Arms  ICMJE
  • Experimental: Group B
    local anesthetics (lidocaine) associated with local steroids (depo-medrol)
    Interventions:
    • Drug: Lidocaine
    • Drug: Depmedrol
  • Experimental: Group C
    local anesthetics (lidocaine) associated with local steroids (depomedrol) and important volumes of physiological serum
    Interventions:
    • Drug: Lidocaine
    • Drug: Depmedrol
    • Other: physiological serum
  • Active Comparator: Group A
    only local anesthetic (lidocaine)
    Intervention: Drug: Lidocaine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 22, 2012)
202
Original Estimated Enrollment  ICMJE
 (submitted: February 25, 2009)
201
Actual Study Completion Date  ICMJE February 2011
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00851513
Other Study ID Numbers  ICMJE BRD08/6-B
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Nantes University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jean-Jacques LABAT CHU de Nantes
PRS Account Nantes University Hospital
Verification Date September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP