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NCT Number: NCT07519915

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

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.

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Key information

Conditions

Gastrointestinal Motility Disorders in Children Colonic Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Constipation - Functional Digestive System Abnormalities Digestive System Diseases Gastrointestinal Diseases Hirschsprung Disease Intestinal Diseases Megacolon

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pediatric Surgery in the Children's Hospital

Erlangen, 91054, Germany

Location status: Recruiting

Location contact

Sonja Diez, PD Dr. med.

CONTACT

[email protected]

0049 9131 8532923

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • indication for analgosedation for MRI
  • inflammatory bowel diseases
  • fractures/different anatomy in sacral region
  • epilepsy
  • presence of cardiac pacemakers

Treatment and study plan

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

Primary outcomes

  1. Fecal incontinence

    Time frame: Within 12 weeks of sacral neuromodulation

    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)

  2. Abdominal pain

    Time frame: Within 12 weeks of sacral neuromodulation

    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

  3. Defecation frequency

    Time frame: Within 12 weeks of sacral neuromodulation

    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))

  4. Urinary incontinence

    Time frame: Within 12 weeks of sacral neuromodulation

    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)

  5. Proprioception

    Time frame: Within 12 weeks of sacral neuromodulation

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Sonja Diez, PD Dr. med.

CONTACT

[email protected]

09131 - 85 32923

Sponsors and collaborators

Lead sponsor

Friedrich-Alexander-Universität Erlangen-Nürnberg

Other

Registry information

Official study title

Stimulation Modeling and Adaptive Response Tracking in Pediatric Gastrointestinal Motility Disorders

Acronym: SMART-GUT

Important dates

Study start
2018
Primary completion
2028
Study completion
2029
First posted
Apr 9, 2026
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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