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Completed

NCT Number: NCT04710433

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

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

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Key information

Conditions

Chronic Constipation With Overflow Anorectal Malformations Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Abnormalities Digestive System Diseases Encopresis With Constipation and Overflow Incontinence Hirschprung's Disease

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 being informed about the study and potential risks of neuromodulation, all included patients and next of kin give written informed consent to the study.

At baseline, patients are classified to one of the two predefined subgroups: either medical and behavioral therapy is extended and optimized or neuromodulatory treatment is started with non-invasive sacral nerve stimulation via single current and two external adhesive electrodes. Within 12 weeks, treatment success is evaluated in routine clinical check-ups (week 4/8/12) and via specialized questionnaires and bowel movement diaries. Quality of life is evaluated at baseline and after 12 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
  • refractory to conventional treatment in a sufficient application (training for bowel movements, lifestyle changes, pelvic floor training)
  • exclusion of metabolic, inflammatory and hormonal causes for chronic constipation (such as e.g., celiac disease, cystic fibrosis, hypothyroidism)
  • in cases of underlying Hirschsprung's disease: confirmation of diagnosis via rectal biopsies
  • in cases of anorectal malformation: post-surgical status

Exclusion criteria

  • metabolic, inflammatory and hormonal causes for chronic constipation with further therapeutic options
  • toxic megacolon or further emergencies, which must be treated surgically
  • 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

Non-invasive Neuromodulation

Device

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

Medical and Behavioral Therapy

Other

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

Primary outcomes

  1. Symptoms: Change in defecation frequency

    Time frame: Baseline and 12 weeks after start of therapy

    Defecation frequency is measured by bowel movements per week.

  2. Symptoms: Change in defecation consistency

    Time frame: Baseline and 12 weeks after start of therapy

    Defecation consistency is measured by the Bristol Stool Scale, which classifies stool consistency from 1 (hard consistency) to 7 (fluid consistency).

  3. Symptoms: Change of encopresis/soiling

    Time frame: Baseline and 12 weeks after start of therapy

    Episodes of encopresis/soiling are evaluated per day.

  4. Change in Quality of Life

    Time frame: Baseline and 12 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.

Secondary outcomes

  1. Symptoms: Change of abdominal pain

    Time frame: Baseline and 12 weeks after start of therapy

    Abdominal pain is recorded in episodes per week and its intensity is evaluated via the numeric rating scale (0=no pain, 10=worst imaginable pain)

Sponsors and collaborators

Lead sponsor

Friedrich-Alexander-Universität Erlangen-Nürnberg

Other

Registry information

Official study title

Non-invasive Sacral Nerve Stimulation in Children and Adolescents With Chronic Constipation: a Case-control Study on External Neuromodulatory Treatment

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jan 14, 2021
Registry last updated
Dec 20, 2022

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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