Clinical trial NCT00851513: Therapeutic Effects Analysis of Pudendal Nerve Infiltrations After 3 Months, in Patients Suffering of Pudendal Neuralgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pudendal Neuralgia
Canal Syndrome
Keywords: Pudendal neuralgia
pudendal nerve
Alcock's canal syndrome
Canal syndrome
neuropathic pain
infiltration
randomized protocol
pain scales
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2009-02-26
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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)

Primary outcomes:
measure: 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 outcomes:
Other outcomes:
Locations:
city: Bayonne
country: France
facility: CH de la Côte Basque
city: Cambo les Bains
country: France
facility: Centre MARIENIA
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Nantes
country: France
facility: CHU de Nantes
city: Nantes
country: France
facility: Catherine de Sienne
city: Paris
country: France
facility: Hôpital Rothschild
city: Rouen
country: France
facility: Scanner Saint Hilaire
city: Rouen
country: France
facility: Hôpital Charles Nicolle
Study officials:
affiliation: Nantes University Hospital
name: Jean-Jacques LABAT
role: PRINCIPAL_INVESTIGATOR
References: