21
Participants
Start Date
January 8, 2019
Primary Completion Date
November 9, 2021
Study Completion Date
November 9, 2021
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.
CHU Brugmann, Brussels
Brugmann University Hospital
OTHER