About this trial
The goal of this study is to learn about the effects of sacral neuromodulation in pediatric patients with gastrointestinal motility disorders. By combining advanced neuroimaging, patient-specific biophysical modeling, electrophysiological characterization, and clinical translation, the SMART-GUT project establishes a comprehensive framework to systematically investigate neuromodulation in this pediatric population. This integrative approach enables a direct link between mechanism, targeting, and clinical outcome.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
informed consent of patient and care taker
gastrointestinal motility disorder, disregarding underlying diseases
exclusion of mechanical obstructions in the gastrointestinal passage
age between 3 and 18
Disqualifiers
pregnancy/breast feeding
decreased renal or thyroidal function
drug intake of Beta-blockers, antispasmodics, cyclopropane, bisulfite compounds, haloperidol, heroin, meperidine, metamizole, methadone, morphine, nitrofurantoin, opium alkaloids, phenobarbital, phenylbutazone, probenecid, rifamycin
contradictions for MRI
Trial design
Sequential
Treatments tested in this trial
SNM/MRI/EMG
Procedure/SurgeryParticipants are receiving clinical baseline evaluation, preoperative sacral and functional MRI, reconstruction of digital twin, surgical implantation of sacral neuromodulation including intraoperative testing, postoperative sacral and functional MRI, and clinical follow-up
Treatment groups
Trial outcomes
Primary outcomes
Fecal incontinence
Changes in the frequency and intensity of fecal incontinence, assessed by specialized questionnaires for patients and parents and analyzed per day (scale \>1x/d; 1x/d; 2-3x/week; 1x/week; \<1x/week and classified as soiling/encopresis)
Abdominal pain
Changes in the frequency and intensity of abdominal pain, , assessed by specialized questionnaires for patients and parents (NRS scale, 0 no pain - 10 maximum pain) and analyzed as episodes per day
Defecation frequency
Changes in defecation frequency per week, assessed by specialized questionnaires for patients and parents (scale \>1x/d; 1x/d; 2-3x/week; 1x/week; \<1x/week and classified regarding consistency based on Bristol Stool Scale (1 hard stool - 7 fluid stool))
Urinary incontinence
Changes in frequency and intensity of urinary incontinence, assessed by specialized questionnaires for patients and parents and analyzed per day (scale \>1x/d; 1x/d; 2-3x/week; 1x/week; \<1x/week)
Sponsors and contacts
Click on the lead sponsor to view all of their trials.