Improvement of Understanding of Pediatric Sacral Neuromodulation: Therapeutic Strategies and Outcome Variables

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-18
SponsorFriedrich-Alexander-Universität Erlangen-Nürnberg

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 volunteers

Qualifiers

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

Design model

Sequential

Treatments tested in this trial

  • SNM/MRI/EMG

    Procedure/Surgery

    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

Treatment groups

25 Participants
are divided into 2 treatment groups
Group A: SNM-guided implantationActive comparator 1 intervention
Group B: SNMNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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)

Time frame
Within 12 weeks of sacral neuromodulation
2

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
3

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
4

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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