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Sacral Neuromodulation in Children and Adolescents

NCT04713085 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-09-08

No results posted yet for this study

Summary

The purpose of this study is to assess the efficacy of neuromodulation for treatment of chronic constipation and fecal incontinence in pediatric patients and to evaluate the differences between the invasive vs. non-invasive approach.

Conditions

  • Chronic Constipation With Overflow
  • Encopresis With Constipation and Overflow Incontinence
  • Hirschsprung's Disease
  • Anorectal Malformations
  • Sacral Dysgenesis

Interventions

DEVICE

Invasive Sacral Neuromodulation

Internal, implanted sacral nerve stimulation (electrodes in contact with neuronal fibers S3/4)

DEVICE

Non-invasive Sacral Neuromodulation

External, non-invasive sacral nerve stimulation via two cutaneously adhesive electrodes (single current).

Sponsors & Collaborators

  • Friedrich-Alexander-Universität Erlangen-Nürnberg

    lead OTHER

Principal Investigators

  • Sonja Diez, M.D. · Friedrich-Alexander-Universität Erlangen-Nürnberg

  • Manuel Besendörfer, M.D. · Friedrich-Alexander-Universität Erlangen-Nürnberg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04713085 on ClinicalTrials.gov