Chronic Constipation With OverflowNCT04713085

Sacral Neuromodulation in Children and Adolescents

A study testing Invasive Sacral Neuromodulation and Non-invasive Sacral Neuromodulation in people with Chronic Constipation With Overflow and Encopresis With Constipation and Overflow Incontinence, run by Friedrich-Alexander-Universität Erlangen-Nürnberg at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 2 to 17 years
Conditions the study is for: Chronic Constipation With Overflow, Encopresis With Constipation and Overflow Incontinence, Hirschsprung's Disease
What is being tested?: Invasive Sacral Neuromodulation and Non-invasive Sacral Neuromodulation
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 1 siteGermany
Study dates: 1 Jan 2019to 31 Dec 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 2 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Germany1 site

Friedrich-Alexander-Universität Erlangen-Nürnberg, Pediatric Surgery
Erlangen, Bavaria, 91054

Other trials in Germany

About this study

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

Read the 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.

Conditions: Chronic Constipation With Overflow, Encopresis With Constipation and Overflow Incontinence, Hirschsprung's Disease, Anorectal Malformations, Sacral Dysgenesis
Being tested: Invasive Sacral Neuromodulation, Non-invasive Sacral Neuromodulation
Keywords: Sacral Nerv Stimulation, Neuromodulation
Medical subject headings: Hirschsprung Disease, Anorectal Malformations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Invasive Sacral NeuromodulationDevice
Internal, implanted sacral nerve stimulation (electrodes in contact with neuronal fibers S3/4)
Non-invasive Sacral NeuromodulationDevice
External, non-invasive sacral nerve stimulation via two cutaneously adhesive electrodes (single current).

Study groups in NCT04713085
Study group	Role	What they receive
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. Receives: 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. Receives: Device: Non-invasive Sacral Neuromodulation

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline and 12 and 24 weeks after start of therapy

Secondary outcomes (4)

Change of proprioception
Improvement of proprioception is measured as mentioned in the specialized questionnaires.
Measured: Baseline and 12 and 24 weeks after start of therapy
Episodes of urinary incontinence
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.
Measured: Baseline and 12 and 24 weeks after start of therapy
Change of Quality of Life
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.
Measured: Baseline and 12 and 24 weeks after start of therapy
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Adverse events are measured as mentioned in the specialized questionnaires: these include cutaneous reactions, urinary incontinence, dysfunction of stimulation or further unknown factors.
Measured: Baseline and 12 and 24 weeks after start of therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 201931 Dec 2024

First posted19 Jan 2021
Study start1 Jan 2019
Primary completion31 Dec 2024
Study completion31 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Chronic Constipation With OverflowStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04713085
Sponsor's protocol ID: 18_20B2
Status last verified: Aug 2025
First submitted: 14 Jan 2021
Last updated: 8 Sep 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Bieling F, Kirchgatter A, Bauer A, Weiss C, Muller H, Matzel KE, Rowald A, Besendorfer M, Diez S. Sacral Neuromodulation in Pediatric Gastrointestinal Motility Disorders: An Exploratory Prospective Cohort Analysis of Clinical Outcomes Based on Different Approaches. Neuromodulation. 2026 Jun 15:S1094-7159(26)00614-8. doi: 10.1016/j.neurom.2026.05.013. Online ahead of print.
PubMed 42467022
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.
PubMed 38515199

Study at a glance

From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Sacral Neuromodulation for Constipation and Fecal Incontinence in Children and Adolescents - Randomized Controlled Trial on the Application of Invasive vs. Non-invasive Technique
ClinicalTrials.gov ID: NCT04713085
Acronym / sponsor ID: 18_20B2
Conditions: Chronic Constipation With Overflow, Encopresis With Constipation and Overflow Incontinence, Hirschsprung's Disease, Anorectal Malformations, Sacral Dysgenesis
Keywords: Sacral Nerv Stimulation, Neuromodulation
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Friedrich-Alexander-Universität Erlangen-NürnbergUniversity, hospital or other
Study start: 1 Jan 2019 (actual)
Primary completion: 31 Dec 2024 (actual)
Study completion: 31 Dec 2024 (actual)
First posted: 19 Jan 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Sacral Neuromodulation	Active comparator	Device: Invasive Sacral NeuromodulationSacral 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.
Non-invasive Sacral Neuromodulation	Active comparator	Device: Non-invasive Sacral NeuromodulationTwo 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.

Who may qualify

Ages: 2 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (6 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Invasive Sacral NeuromodulationInternal, implanted sacral nerve stimulation (electrodes in contact with neuronal fibers S3/4)	Device	Sacral Neuromodulation
Non-invasive Sacral NeuromodulationExternal, non-invasive sacral nerve stimulation via two cutaneously adhesive electrodes (single current).	Device	Non-invasive Sacral Neuromodulation

Primary outcome

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
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
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
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

4 secondary outcomes

Change of proprioception
Time frame: 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
Change of Quality of Life
Time frame: 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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
Derived from this study: PubMed 42467022Bieling F, Kirchgatter A, Bauer A, Weiss C, Muller H, Matzel KE, Rowald A, Besendorfer M, Diez S. Sacral Neuromodulation in Pediatric Gastrointestinal Motility Disorders: An Exploratory Prospective Cohort Analysis of Clinical Outcomes Based on Different Approaches. Neuromodulation. 2026 Jun 15:S1094-7159(26)00614-8. doi: 10.1016/j.neurom.2026.05.013. Online ahead of print.
Derived from this study: PubMed 38515199Besendorfer 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.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sonja Diez, M.D. principal investigator

Friedrich-Alexander-Universität Erlangen-Nürnberg

Manuel Besendörfer, M.D. principal investigator

Friedrich-Alexander-Universität Erlangen-Nürnberg

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of episodes of abdominal pain (time frame: Baseline and 12 and 24 weeks after start of therapy). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04713085, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.