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.
Patients enrolled in the study will be receiving sacral neuromodulation (via surgical implantation) and MRIs prior to neuromodulation treatment and after 12 weeks. In cases of surgical implantation, the intraoperative testing is accompanied by a broad neuronal evaluation (The goal is to establish with these informations * improved understanding of interindividual sacral nerval anatomy * improved guidelines for implantation of sacral neuromodulation via 3D reconstructions (digital twins) * prediction of neural activation by sacral neuromodulation and improvement of response rates * mechanism guided implantation based on clinical symptoms (fecal incontinence vs. leading constipative symptoms) * improvement of therapeutic efficacy in comparison to non-guided implantation
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Participants 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
Pediatric Surgery in the Children's Hospital
Erlangen, Germany
RECRUITINGFecal 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)
Time frame: Within 12 weeks of sacral neuromodulation
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
Time frame: Within 12 weeks of sacral neuromodulation
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))
Time frame: Within 12 weeks of sacral neuromodulation
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)
Time frame: Within 12 weeks of sacral neuromodulation
Proprioception
Changes in the proprioception of urge to defecate, assessed by specialized questionnaires for patients and parents and analyzed per day (scale normal urge to defecate without soiling/encopresis; rare urge to defecate with soiling/encopresis; no urge to defecate with soiling/encopresis)
Time frame: Within 12 weeks of sacral neuromodulation
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