Multicenter European study to evaluate efficacy and safety of sacral nerve stimulation with InterStim Therapy to treat fecal incontinence or constipation
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
140
Treatment with InterStim Therapy: all patients meeting inclusion/exclusion criteria undergo test screening and those who have successful outcomes receive a permanent implant.
University of Minnesota
Minneapolis, Minnesota, United States
Danube Hospital/SMZ-Ost
Vienna, Austria
Aarhus University Hospital
Aarhus, Denmark
Herlev Hospital
Copenhagen, Denmark
FI - number of FI episodes per week and/or number of days with FI per week. Constipation - number of bowel movements per week; &/or decrease defecations requiring straining; &/or decrease defecations where there was incomplete emptying
Time frame: Annually
FI-number of days with staining/week;urgency with continent bowel movements; Improvement in QOL;* Improvement in anal canal pressure. Constipation - Improvement in Wexner constipation score; QOL.
Time frame: Annually
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University Hospital Erlangen
Erlangen, Germany
Maastricht University Hospital
Maastricht, Netherlands
Hospital Mutua de Terrassa
Terrassa, Spain
Danderyd Hospital
Stockholm, Sweden
St. Mark's Hospital
London, United Kingdom