Sacral Neuromodulation in Children and Adolescents

NCT04713085 | Completed

• 1 other identifier: 18_20B2
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Sacral Nerv Stimulation; Neuromodulation

Outcome Measures

Primary Outcomes (4)

• Change of episodes of abdominal pain

  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

  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

  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

  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 Outcomes (4)

• Change of proprioception

  Baseline and 12 and 24 weeks after start of therapy

• Episodes of urinary incontinence

  Baseline and 12 and 24 weeks after start of therapy

• Change of Quality of Life

  Baseline and 12 and 24 weeks after start of therapy

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

  Baseline and 12 and 24 weeks after start of therapy

Study Arms (2)

Sacral Neuromodulation

ACTIVE COMPARATOR

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

Non-invasive Sacral Neuromodulation

ACTIVE COMPARATOR

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

Interventions

Invasive Sacral Neuromodulation DEVICE

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

Sacral Neuromodulation

Non-invasive Sacral Neuromodulation DEVICE

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

Non-invasive Sacral Neuromodulation

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Friedrich-Alexander-Universität Erlangen-Nürnberg: lead

Study Sites (1)

Friedrich-Alexander-Universität Erlangen-Nürnberg, Pediatric Surgery

Erlangen, Bavaria, 91054, Germany

Location

Related Publications (1)

• Besendorfer M, Kirchgatter A, Carbon R, Weiss C, Muller H, Matzel KE, Diez S. Sacral neuromodulation for constipation and fecal incontinence in children and adolescents - study protocol of a prospective, randomized trial on the application of invasive vs. non-invasive technique. Trials. 2024 Mar 22;25(1):210. doi: 10.1186/s13063-024-08052-6.

  PMID: 38515199 DERIVED

MeSH Terms

Conditions

Hirschsprung Disease; Anorectal Malformations

Condition Hierarchy (Ancestors)

Digestive System Abnormalities; Digestive System Diseases; Megacolon; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Sonja Diez, M.D.

  Friedrich-Alexander-Universität Erlangen-Nürnberg

  PRINCIPAL INVESTIGATOR

• Manuel Besendörfer, M.D.

  Friedrich-Alexander-Universität Erlangen-Nürnberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, M.D.

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: January 19, 2021
• Study Start: January 1, 2019
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: September 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)