Implantation of a Pudendal PNA Test Lead for Neuromodulation by the ENTRAMI Technique in Case of Chronic Perineal Pain Syndrome.

NACompletedINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

January 8, 2019

Primary Completion Date

November 9, 2021

Study Completion Date

November 9, 2021

Conditions
Pudendal Impingement Syndrome
Interventions
DEVICE

pudendal PNE test lead

All patients eligible for release surgery will be implanted a PNE test lead (Medtronic) which will be placed (transforaminal or transgluteally) next to the pudendal nerve, at the level of the ischial spine, after surgical release and connected to an external stimulation device. The PNE lead will be fixed at the ischial-spinal ligament with an absorbable suture to prevent dislocation. If a bilateral dissection is needed, bilateral test leads will be placed. Stimulation will be switched on at the second postoperative day, according to the sensory threshold described by the patient. After three weeks the PNE test lead will be removed at the outpatient clinical visit.

Trial Locations (1)

1020

CHU Brugmann, Brussels

All Listed Sponsors
lead

Brugmann University Hospital

OTHER

NCT03880786 - Implantation of a Pudendal PNA Test Lead for Neuromodulation by the ENTRAMI Technique in Case of Chronic Perineal Pain Syndrome. | Biotech Hunter | Biotech Hunter