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Completed

NCT Number: NCT04713085

Sacral Neuromodulation in Children and Adolescents

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.

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Key information

Conditions

Chronic Constipation With Overflow Anorectal Malformations Colonic Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Abnormalities Digestive System Diseases Encopresis With Constipation and Overflow Incontinence Gastrointestinal Diseases Hirschsprung Disease Hirschsprung's Disease Intestinal Diseases Megacolon Sacral Dysgenesis

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Friedrich-Alexander-Universität Erlangen-Nürnberg, Pediatric Surgery

Erlangen, Bavaria, 91054, Germany

About this study

Patients are selected according to the eligibility requirements. After obtaining informed consent off-label use and potential risks of sacral neuromodulation, all included patients and next of kin give written informed consent to the study.

At baseline, patients are randomized to one of the two predefined subgroups: either invasive sacral neuromodulation or non-invasive sacral neuromodulation. Clinical symptoms and outcome variables are compared regarding the beginning of non-invasive sacral neuromodulation or the implantation of the tined lead electrode. Patients are closely monitored within 6 months. Treatment success is evaluated in routine clinical check-ups (week 4/8/12 and 24) and via specialized questionnaires and bowel movement diaries. Quality of life is evaluated at baseline and after 12 and 24 weeks of treatment.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • age between 2-17 years
  • informed consent
  • chronic constipation according to the ROME IV criteria for more than 3 months with or without encopresis/soiling despite underlying diseases such as slow-transit constipation, rectal evacuation disorders or Hirschsprung's disease.
  • refractory to conventional treatment in an appropriate weight-adapted application (training for bowel movements, lifestyle changes, pelvic floor training, pharmacological options)
  • in cases of Hirschsprung's disease: diagnosis confirmed histologically by rectal biopsies and in case of resection of an aganglionic segement: period between surgery and SNM at least 1 year
  • in cases of anorectal malformation or mechanical obstruction: post-surgical status: period between surgery and SNM at least 1 year

Exclusion criteria

  • metabolic, inflammatory, and hormonal causes for chronic constipation
  • toxic megacolon or further emergencies, which must be treated surgically
  • sacral fractures or substantial differences in the sacral anatomy
  • inflammatory bowel disorders
  • rectal prolapse
  • neuronal malignancies under medical and radiation therapy
  • seizures

Treatment and study plan

Invasive Sacral Neuromodulation

Device

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

Non-invasive Sacral Neuromodulation

Device

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

Primary outcomes

  1. Change of episodes of abdominal pain

    Time frame: Baseline and 12 and 24 weeks after start of therapy

    Abdominal pain is recorded in number of episodes per week. Its intensity is evaluated via the numeric rating scale (0=no pain, 10=worst imaginable pain). Definition of success: reduction by at least 50% of episodes per week

  2. Change of episodes of fecal incontinence

    Time frame: Baseline and 12 and 24 weeks after start of therapy

    Number of episodes of fecal incontinence per week. Definition of success: reduction by at least 50% of episodes per week

  3. Change of defecation frequency

    Time frame: Baseline and 12 and 24 weeks after start of therapy

    Defecation frequency is measured by number of bowel movements per week. Definition of success: doubling of episodes per week to at least 3 or more bowel movements per week

  4. Change of defecation consistency

    Time frame: Baseline and 12 and 24 weeks after start of therapy

    Defecation consistency is measured daily by the Bristol Stool Scale, which classifies stool consistency from 1 (hard consistency) to 7 (fluid consistency). Definition of success: change of at least 2 points within the scale of 1-7

Secondary outcomes

  1. Change of proprioception

    Time frame: Baseline and 12 and 24 weeks after start of therapy

    Improvement of proprioception is measured as mentioned in the specialized questionnaires.

  2. Episodes of urinary incontinence

    Time frame: Baseline and 12 and 24 weeks after start of therapy

    The number of episodes per week is evaluated with the criterion for a clinically relevant improvement in cases of reduction by at least 50% of episodes per week.

  3. Change of Quality of Life

    Time frame: Baseline and 12 and 24 weeks after start of therapy

    The quality of life is classified via the 'Revised Children's Quality of Life Questionnaire' (KINDLR). It consists of 24 5-point Likert-scale items, covering 6 quality of life dimensions: physical well-being, emotional well-being, self-esteem, family, friends and daily functioning (school or nursery school/kindergarten). Items are partially reverse scored and linearly transformed to a 0 to 100 scale according to the manual. Higher scores indicate a better quality of life.

  4. Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

    Time frame: Baseline and 12 and 24 weeks after start of therapy

    Adverse events are measured as mentioned in the specialized questionnaires: these include cutaneous reactions, urinary incontinence, dysfunction of stimulation or further unknown factors.

Sponsors and collaborators

Lead sponsor

Friedrich-Alexander-Universität Erlangen-Nürnberg

Other

Registry information

Official study title

Sacral Neuromodulation for Constipation and Fecal Incontinence in Children and Adolescents - Randomized Controlled Trial on the Application of Invasive vs. Non-invasive Technique

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Jan 19, 2021
Registry last updated
Sep 8, 2025

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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