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

Phase 4

Completed

• Conditions: Pudendal Neuralgia; Canal Syndrome
• Interventions: Drug: Lidocaine; Drug: Depmedrol; Other: physiological serum

• Registration Number: NCT00851513
• Lead Sponsor: Nantes University Hospital

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 available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2009-02-25
• Study First Submitted QC: 2009-02-25
• Study First Posted: 2009-02-26
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-02
• Last Update Posted: 2013-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 202

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	Depmedrol	local anesthetics (lidocaine) associated with local steroids (depo-medrol)
Group C	Lidocaine	local anesthetics (lidocaine) associated with local steroids (depomedrol) and important volumes of physiological serum
Group C	Depmedrol	local anesthetics (lidocaine) associated with local steroids (depomedrol) and important volumes of physiological serum
Group C	physiological serum	local anesthetics (lidocaine) associated with local steroids (depomedrol) and important volumes of physiological serum
Group B	Lidocaine	local anesthetics (lidocaine) associated with local steroids (depo-medrol)
Group A	Lidocaine	only local anesthetic (lidocaine)

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (9)

CH de la Côte Basque; 🇫🇷 Bayonne, France

CHU de Nantes; 🇫🇷 Nantes, France

Scanner Saint Hilaire; 🇫🇷 Rouen, France

Hôpital Rothschild; 🇫🇷 Paris, France

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

Catherine de Sienne; 🇫🇷 Nantes, France

Hospices Civils de Lyon; 🇫🇷 Lyon, France

Hôpital Charles Nicolle; 🇫🇷 Rouen, France

Centre MARIENIA; 🇫🇷 Cambo les Bains, France