55
Participants
Start Date
October 23, 2012
Primary Completion Date
September 20, 2017
Study Completion Date
January 23, 2018
Unilateral electrode placement and testing
An electrode is placed near a sacral nerve with an anal motor response under general anesthesia. During and adjustment phase, the electode is connected to a test box which allows for adjustment of stimulation parameters. After pinpointing stimulation parameters, the external test box is replaced by an implanted device.
Bilateral electrode placement and testing
Two electrodes are placed, one near each sacral nerve under general anesthesia. During an adjustment phase, the electodes are connected to a test box which allows for adjustment of stimulation parameters. This can result in the use of one or the other, or both electrodes, thus increasing the chances of success and the possibility that the patient is eligible for an implant. After pinpointing stimulation parameters, the external test box is replaced by an implanted device.
CHU de Nîmes - Hôpital Universitaire Carémeau, Nîmes
CHRU de Toulouse - Hôpital de Rangueil, Toulouse
Clinique Beau Soleil, Montpellier
CHU de Nantes - Hôtel Dieu, Nantes
APHP - Groupe Hospitalier Pitié-Salpetrière, Paris
CHU de Rouen - Hôpital Charles Nicolle, Rouen
Centre Hospitalier Universitaire de Nīmes
OTHER