Therapeutic Effects Analysis of Pudendal Nerve Infiltrations After 3 Months, in Patients Sufferin… (NCT00851513) | Clinical Trial Compass
CompletedPhase 4
Therapeutic Effects Analysis of Pudendal Nerve Infiltrations After 3 Months, in Patients Suffering of Pudendal Neuralgia
France202 participantsStarted 2008-11
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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