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

Pudendal Neuralgia Clinical Trial

— INFILTHERA  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00851513
• Other study ID #: BRD08/6-B
• Status: Completed
• Phase: Phase 4
• First received: February 25, 2009
• Last updated: September 2, 2013
• Start date: November 2008
• Est. completion date: February 2011

Study information

• Verified date: September 2013
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

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

Related Conditions & MeSH terms

• Canal Syndrome
• Neuralgia
• Pudendal Neuralgia

Intervention

Drug:
• Lidocaine
local anesthetics
• Depmedrol
local steroids

Other:
• physiological serum
important volumes of physiological serum

Locations

Country	Name	City	State
France	CH de la Côte Basque	Bayonne
France	Centre MARIENIA	Cambo les Bains
France	CHU Clermont-Ferrand	Clermont-Ferrand
France	Hospices Civils de Lyon	Lyon
France	Catherine de Sienne	Nantes
France	CHU de Nantes	Nantes
France	Hôpital Rothschild	Paris
France	Hôpital Charles Nicolle	Rouen
France	Scanner Saint Hilaire	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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