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Can a nerve zap cure Kids' stubborn constipation?

NCT ID NCT04713085

Disease control Sponsor: Friedrich-Alexander-Universität Erlangen-Nürnberg Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tested two ways to stimulate sacral nerves in 48 children aged 2-17 with severe constipation and fecal incontinence that didn't improve with standard care. One group got an implanted nerve stimulator, the other a non-invasive patch. The goal was to see if either approach could reduce pain, improve bowel movements, and cut down on accidents.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sacral nerve stimulation (implanted or external patch)
What this could lead to
If successful, this could offer a new option for children with severe constipation and fecal incontinence that hasn't improved with standard treatments.
What could go wrong
This is a small, completed trial with only 48 children. The results may not apply to all kids, and the invasive implant carries surgical risks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

48 people

The number who actually took part.

Started

Jan 2019

Finished

Dec 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

anorectal malformation Anorectal Malformations caudal regression sequence constipation disorder Hirschsprung disease imperforate anus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anorectal malformations Chronic constipation with overflow Encopresis with constipation and overflow incontinence Hirschsprung's disease Sacral dysgenesis

Contacts and locations

Locations

  • Friedrich-Alexander-Universität Erlangen-Nürnberg, Pediatric Surgery

    Erlangen, Bavaria, 91054, Germany

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