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

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

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Key information

Conditions

Pudendal Neuralgia Canal Syndrome Nerve Compression Syndromes Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CH de la Côte Basque, Bayonne, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Lidocaine

Drug

local anesthetics

Depmedrol

Drug

local steroids

physiological serum

Other

important volumes of physiological serum

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Acronym: INFILTHERA

Important dates

Study start: 2008
Primary completion: 2011
Study completion: 2011
First posted: Feb 26, 2009
Registry last updated: Sep 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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