Effectiveness of Sacral Neuromodulation in Low Anterior Resection Syndrome

NACompletedINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

May 25, 2018

Primary Completion Date

February 17, 2021

Study Completion Date

February 17, 2022

Conditions
Low Anterior Resection SyndromeSacral Neuromodulation - Interstim TherapyRectal Cancer
Interventions
DEVICE

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."

Trial Locations (1)

Unknown

Hospital Universitari Vall d'Hebrón Research Institute, Barcelona

All Listed Sponsors
collaborator

Hospital Universitari de Bellvitge

OTHER

collaborator

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

OTHER

lead

Hospital Universitari Vall d'Hebron Research Institute

OTHER

NCT03598231 - Effectiveness of Sacral Neuromodulation in Low Anterior Resection Syndrome | Biotech Hunter | Biotech Hunter