45
Participants
Start Date
May 25, 2018
Primary Completion Date
February 17, 2021
Study Completion Date
February 17, 2022
Sacral neuromodulation
"After the definitive implantation, stimulators are placed in position OFF for the first arm and in position ON for the second arm during 4 weeks.~Then all the stimulators are switched OFF (both first and second arms) for 2 weeks.~Finally stimulators are maintained in position ON for the first arm and switched OFF for the second arm during 4 weeks.~Since this is a cross-over study, patients can be randomly assigned to any arm first, but they will go to the other arm since the patient is its own control. 50% of randomized patients will go through ON-OFF and the other 50% OFF-ON.~After this cross-over phase, ALL stimulators will be in ON position until the end of the study period."
Hospital Universitari Vall d'Hebrón Research Institute, Barcelona
Hospital Universitari de Bellvitge
OTHER
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
OTHER
Hospital Universitari Vall d'Hebron Research Institute
OTHER