NCT00851513

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
202

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2008

Typical duration for phase_4

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 26, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

September 4, 2013

Status Verified

September 1, 2013

Enrollment Period

2.3 years

First QC Date

February 25, 2009

Last Update Submit

September 2, 2013

Conditions

Pudendal NeuralgiaCanal Syndrome

Keywords

Pudendal neuralgiapudendal nerveAlcock's canal syndromeCanal syndromeneuropathic paininfiltrationrandomized protocolpain scales

Outcome Measures

Primary Outcomes (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

Study Arms (3)

Group B

EXPERIMENTAL

local anesthetics (lidocaine) associated with local steroids (depo-medrol)

Drug: LidocaineDrug: Depmedrol

Group C

EXPERIMENTAL

local anesthetics (lidocaine) associated with local steroids (depomedrol) and important volumes of physiological serum

Drug: LidocaineDrug: DepmedrolOther: physiological serum

Group A

ACTIVE COMPARATOR

only local anesthetic (lidocaine)

Drug: Lidocaine

Interventions

LidocaineDRUG

local anesthetics

Group AGroup BGroup C
DepmedrolDRUG

local steroids

Group BGroup C
physiological serumOTHER

important volumes of physiological serum

Group C

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

CH de la Côte Basque

Bayonne, 64100, France

Location

Centre MARIENIA

Cambo-les-Bains, 64250, France

Location

CHU Clermont-Ferrand

Clermont-Ferrand, 63058, France

Location

Hospices Civils de Lyon

Lyon, 69495, France

Location

CHU de Nantes

Nantes, 44093, France

Location

Catherine de Sienne

Nantes, 44200, France

Location

Hôpital Rothschild

Paris, 75571, France

Location

Scanner Saint Hilaire

Rouen, 76000, France

Location

Hôpital Charles Nicolle

Rouen, 76031, France

Location

MeSH Terms

Conditions

Pudendal NeuralgiaNeuralgia

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Nerve Compression SyndromesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Jean-Jacques LABAT

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 25, 2009

First Posted

February 26, 2009

Study Start

November 1, 2008

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

September 4, 2013

Record last verified: 2013-09

Locations

FR(9)