Therapeutic Effects Analysis of Pudendal Nerve Infiltrations After 3 Months, in Patients Suffering of Pudendal Neuralgia (INFILTHERA)
Primary Purpose
Pudendal Neuralgia, Canal Syndrome
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Lidocaine
Depmedrol
physiological serum
Sponsored by
About this trial
This is an interventional treatment trial for Pudendal Neuralgia focused on measuring Pudendal neuralgia, pudendal nerve, Alcock's canal syndrome, Canal syndrome, neuropathic pain, infiltration, randomized protocol, pain scales
Eligibility 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 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)
Sites / Locations
- CH de la Côte Basque
- Centre MARIENIA
- CHU Clermont-Ferrand
- Hospices Civils de Lyon
- CHU de Nantes
- Catherine de Sienne
- Hôpital Rothschild
- Scanner Saint Hilaire
- Hôpital Charles Nicolle
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Group B
Group C
Group A
Arm Description
local anesthetics (lidocaine) associated with local steroids (depo-medrol)
local anesthetics (lidocaine) associated with local steroids (depomedrol) and important volumes of physiological serum
only local anesthetic (lidocaine)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT00851513
First Posted
February 25, 2009
Last Updated
September 2, 2013
Sponsor
Nantes University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00851513
Brief Title
Therapeutic Effects Analysis of Pudendal Nerve Infiltrations After 3 Months, in Patients Suffering of Pudendal Neuralgia
Acronym
INFILTHERA
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Nantes University Hospital
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pudendal Neuralgia, Canal Syndrome
Keywords
Pudendal neuralgia, pudendal nerve, Alcock's canal syndrome, Canal syndrome, neuropathic pain, infiltration, randomized protocol, pain scales
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
202 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group B
Arm Type
Experimental
Arm Description
local anesthetics (lidocaine) associated with local steroids (depo-medrol)
Arm Title
Group C
Arm Type
Experimental
Arm Description
local anesthetics (lidocaine) associated with local steroids (depomedrol) and important volumes of physiological serum
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
only local anesthetic (lidocaine)
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Description
local anesthetics
Intervention Type
Drug
Intervention Name(s)
Depmedrol
Intervention Description
local steroids
Intervention Type
Other
Intervention Name(s)
physiological serum
Intervention Description
important volumes of physiological serum
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Jacques LABAT
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CH de la Côte Basque
City
Bayonne
ZIP/Postal Code
64100
Country
France
Facility Name
Centre MARIENIA
City
Cambo les Bains
ZIP/Postal Code
64250
Country
France
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63058
Country
France
Facility Name
Hospices Civils de Lyon
City
Lyon
ZIP/Postal Code
69495
Country
France
Facility Name
CHU de Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Catherine de Sienne
City
Nantes
ZIP/Postal Code
44200
Country
France
Facility Name
Hôpital Rothschild
City
Paris
ZIP/Postal Code
75571
Country
France
Facility Name
Scanner Saint Hilaire
City
Rouen
ZIP/Postal Code
76000
Country
France
Facility Name
Hôpital Charles Nicolle
City
Rouen
ZIP/Postal Code
76031
Country
France
12. IPD Sharing Statement
Learn more about this trial
Therapeutic Effects Analysis of Pudendal Nerve Infiltrations After 3 Months, in Patients Suffering of Pudendal Neuralgia
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