Improvement of Understanding of Pediatric Sacral Neuromodulation: Therapeutic Strategies and Outcome Variables (SMART-GUT)

April 6, 2026 updated by: Dr. med. Sonja Diez, Friedrich-Alexander-Universität Erlangen-Nürnberg

Stimulation Modeling and Adaptive Response Tracking in Pediatric Gastrointestinal Motility Disorders

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Estimated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Erlangen, Germany, 91054
        • Recruiting
        • Pediatric Surgery in the Children's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: SNM-guided implantation
Surgical implantation of sacral neuromodulation after generation of digital twin and intraoperative efficacy testing
Procedure: SNM/MRI/EMG
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
No Intervention: SNM
SNM implantation based on general knowledge and adult measurements

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Within 12 weeks of sacral neuromodulation
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
Within 12 weeks of sacral neuromodulation
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))
Within 12 weeks of sacral neuromodulation
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)
Within 12 weeks of sacral neuromodulation
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)
Within 12 weeks of sacral neuromodulation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Friedrich-Alexander-Universität Erlangen-Nürnberg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2018

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

March 28, 2026

First Submitted That Met QC Criteria

April 6, 2026

First Posted (Actual)

April 9, 2026

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 6, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMART-GUT_V1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data can be shared on reasonable request.

IPD Sharing Time Frame

Within the duration of the study

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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