MedTrace Logo

Non-invasive Sacral Nerve Stimulation in Children and Adolescents With Chronic Constipation

NCT04710433 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2022-12-20

No results posted yet for this study

Summary

The purpose of this study is to assess the efficacy of additional neuromodulation for treatment of chronic constipation in pediatric patients

Conditions

  • Chronic Constipation With Overflow
  • Encopresis With Constipation and Overflow Incontinence
  • Hirschprung's Disease
  • Anorectal Malformations

Interventions

DEVICE

Non-invasive Neuromodulation

Sacral nerve stimulation via two adhesive electrodes (single current).

OTHER

Medical and Behavioral Therapy

Behavioral Therapy consists of toilet training, an active and healthy lifestyle. Doses of medical options are applied weight-adjusted.

Sponsors & Collaborators

  • Friedrich-Alexander-Universität Erlangen-Nürnberg

    lead OTHER

Principal Investigators

  • Sonja Diez, MD · Friedrich-Alexander-Universität Erlangen-Nürnberg

  • Manuel Besendörfer, MD · Friedrich-Alexander-Universität Erlangen-Nürnberg

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • Germany

Study Locations

More Related Trials

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 NCT04710433 on ClinicalTrials.gov