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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


Clinical Trial Description

n/a


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


NCT number NCT00851513
Study type Interventional
Source Nantes University Hospital
Contact
Status Completed
Phase Phase 4
Start date November 2008
Completion date February 2011

See also
  Status Clinical Trial Phase
Not yet recruiting NCT05531500 - Patient Reported Outcomes Following Interventional Procedures in Pelvic Pain N/A
Completed NCT02564172 - Conus Medullaris Stimulation With 5 Columns Lead Versus Medical Treatment in Refractory Pudendal Neuralgia N/A
Recruiting NCT06461312 - Combined PRF of the Pudendal Nerve With Ganglion Impar Block Effectively Alleviates Pudendal Neuralgia N/A
Completed NCT04455659 - Impact of Adding TENS to Conventional Physical Therapy Exercise on Pain Relief Among Patients With Pudendal Neuralgia. N/A
Recruiting NCT06413277 - Targeting the Conus Medullaris With ECAP-Controlled Closed-Loop SCS for Treatment of Chronic Pelvic Pain: HOPE Trial
Completed NCT04509518 - Effectiveness of Selected Physical Therapy Exercise Program and Transcutaneous Electrical Nerve Stimulation on Patients With Pudendal Neuralgia N/A
Active, not recruiting NCT04198714 - Pudendal Nerve Block in Vaginal Surgery N/A