Sacral Neuromodulation in Children and Adolescents

February 25, 2024 updated by: Dr. med. Sonja Diez, Friedrich-Alexander-Universität Erlangen-Nürnberg

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
    • Bavaria
      • Erlangen, Bavaria, Germany, 91054
        • Recruiting
        • Friedrich-Alexander-Universität Erlangen-Nürnberg, Pediatric Surgery
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sacral Neuromodulation

Sacral neuromodulation is surgically implanted within two surgeries:

  1. Implantation of the final electrode (tined-lead electrode): This electrode is implanted to neuronal fibers of S3/4. Both sides are tested intraoperatively, the side with a sufficient response at lower intensity levels is finally implanted. Stimulation is conducted via an external pulse generator.
  2. Implantation of the internal pacemaker system 4 weeks after the electrode's implantation.

Stimulation parameters: Single current, frequency 15Hz, duration 210μs. Stimulation intensity is individually determined beyond the pain threshold (adjustable amplitude between 0-10mA, depending on the intraoperative response).

Start point of clinical evaluation is time of implantation of tined lead electrode.

Medical and behavioral therapy is to be continued as started before intervention.
Device: Invasive Sacral Neuromodulation
Internal, implanted sacral nerve stimulation (electrodes in contact with neuronal fibers S3/4)
Active Comparator: Non-invasive Sacral Neuromodulation

Two adhesive electrodes are placed paravertebrally between L1 and L4 and periumbilically, generating an electrical field by single current with a 15 Hz frequency for a duration of 210μs. Stimulation intensity is individually determined to achieve an effective and comfortable stimulation beyond the pain threshold (adjustable amplitude between 0-10mA).

Start point of clinical evaluation is start of external stimulation.

Medical and behavioral therapy is to be continued as started before intervention.
Device: Non-invasive Sacral Neuromodulation
External, non-invasive sacral nerve stimulation via two cutaneously adhesive electrodes (single current).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline and 12 and 24 weeks after start of therapy
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
Baseline and 12 and 24 weeks after start of therapy
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
Baseline and 12 and 24 weeks after start of therapy
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
Baseline and 12 and 24 weeks after start of therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 12 and 24 weeks after start of therapy
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.
Baseline and 12 and 24 weeks after start of therapy
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.
Baseline and 12 and 24 weeks after start of therapy
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.
Baseline and 12 and 24 weeks after start of therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Friedrich-Alexander-Universität Erlangen-Nürnberg

Investigators

  • Principal Investigator: Sonja Diez, M.D., Friedrich-Alexander-Universität Erlangen-Nürnberg
  • Principal Investigator: Manuel Besendörfer, M.D., Friedrich-Alexander-Universität Erlangen-Nürnberg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

January 14, 2021

First Submitted That Met QC Criteria

January 14, 2021

First Posted (Actual)

January 19, 2021

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 25, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18_20B2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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