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Shocking constipation away: nerve zap trial for kids

NCT ID NCT06528470

Symptom relief Sponsor: Nationwide Children's Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This completed trial tested whether a nerve stimulation treatment called PTNS can help children aged 8-18 with constipation caused by pelvic floor dyssynergia. Forty participants received either real PTNS or a sham (fake) treatment to see if it improves bowel function. The goal is to find a new, non-surgical option for this tough-to-treat condition.

What this could mean

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

Active substance
Posterior Tibial Nerve Stimulation (PTNS) device
What this could lead to
If it works, this could offer a non-drug, non-surgical option to help children with constipation due to pelvic floor dyssynergia.
What could go wrong
This is a small pilot study (40 children) with no phase designation, so results may not be conclusive or widely applicable. The treatment involves needle insertion, which may cause discomfort.

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

40 people

The number who actually took part.

Started

Jan 2020

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

8 to 18 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: * Patients 8-18 years of age * Diagnosis of constipation due to pelvic floor dyssynergia * Scheduled to start pelvic floor biofeedback therapy. Exclusion Criteria: \- Prior surgery for constipation (colonic resection, cecostomy, Malone appendicostomy, sacral nerve stimulator implantation, etc.)

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Conditions

The condition(s) this trial relates to.

anismus constipation disorder Fecal Incontinence

As listed by the trial registrant

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

Constipation Fecal incontinence in children Pelvic floor dyssynergia

Contacts and locations

Locations

  • Nationwide Children's Hospital

    Columbus, Ohio, 43220, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.