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

NCT07519915 | Recruiting

• 1 other identifier: SMART-GUT_V1
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hirschsprung Disease; Constipation - Functional; Gastrointestinal Motility Disorders in Children

Keywords

pediatric gastrointestinal motility disorders; chronic constipation; Hirschsprung disease; sacral neuromodulation

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

SNM-guided implantation

ACTIVE COMPARATOR

Surgical implantation of sacral neuromodulation after generation of digital twin and intraoperative efficacy testing

Procedure: SNM/MRI/EMG

SNM

NO INTERVENTION

SNM implantation based on general knowledge and adult measurements

Interventions

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

SNM-guided implantation

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• informed consent of patient and care taker
• gastrointestinal motility disorder, disregarding underlying diseases
• age between 3 and 18

You may not qualify if:

• 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

Sponsors & Collaborators

• Friedrich-Alexander-Universität Erlangen-Nürnberg: lead

Study Sites (1)

Pediatric Surgery in the Children's Hospital

Erlangen, 91054, Germany

RECRUITING

MeSH Terms

Conditions

Hirschsprung Disease

Condition Hierarchy (Ancestors)

Digestive System Abnormalities; Digestive System Diseases; Megacolon; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Sonja Diez, PD Dr. med.

CONTACT

09131 - 85 32923; sonja.diez@uk-erlangen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Managing senior physician of Pediatric Surgery, University Hospital Erlangen, and PI of SMART-GUT

Study Record Dates

• First Submitted: March 28, 2026
• First Posted: April 9, 2026
• Study Start: July 1, 2018
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Within the duration of the study

Locations

DE (1)