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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SNM-guided implantation | Active Comparator | Surgical implantation of sacral neuromodulation after generation of digital twin and intraoperative efficacy testing |
|
| SNM | No Intervention | SNM implantation based on general knowledge and adult measurements |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SNM/MRI/EMG | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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 | 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)) | 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) | 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) | Within 12 weeks of sacral neuromodulation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sonja Diez, PD Dr. med. | Contact | 09131 - 85 32923 | sonja.diez@uk-erlangen.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pediatric Surgery in the Children's Hospital | Recruiting | Erlangen | 91054 | Germany |
Data can be shared on reasonable request.
Within the duration of the study
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|
| ID | Term |
|---|---|
| D006627 | Hirschsprung Disease |
| ID | Term |
|---|---|
| D004065 | Digestive System Abnormalities |
| D004066 | Digestive System Diseases |
| D008531 | Megacolon |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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