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Shock therapy for leaky bowels? new device shows promise

NCT ID NCT05864807

Symptom relief Sponsor: InnoCon Medical 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tested a device called UCon for people with fecal incontinence (unexpected bowel leakage). The device sends mild electrical pulses through the skin to calm overactive bowel muscles. Thirty adults used it at home to see if it was safe and if it reduced their symptoms by at least half.

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

30 people

The number who actually took part.

Started

Aug 2023

Finished

Feb 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 years and older

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: 1. Participant is ≥ 18 years of age. 2. Participant is showing symptoms of FI. 3. Participant is able to communicate, provide feedback, understand and follow instructions during the course of the investigation, including using the device at home. Exclusion Criteria: 1. Participant is medically unstable (acute illness or complication of a chronic condition that might affect the participants´ participation in the investigation). 2. Participant has an active infection in the genital area. 3. Participant has an implanted pacemaker, implantable drug pump or other active medical device (any medical device that uses electrical energy or other source of power to make it function). 4. Participant is pregnant, nursing or planning a pregnancy (to be confirmed with a negative pregnancy test). Women of childbearing potential must maintain effective contraception\* during the interventional period judged by the investigator. 5. Participant is enrolled or planning to enrol in another clinical investigation or was enrolled in an investigational drug trial or medical device investigation within four weeks to enrolment. 6. Participant has neuropathy to a degree that is presumed to diminish the effect of the electrical stimulation, e.g., denervated patients and severe diabetic neuropathy. 7. Participant is currently receiving cancer treatment. 8. Participant has addictive behaviour defined as abuse of alcohol, cannabis, opioids, or other intoxicating drugs. 9. Participant does not speak and understand Spanish. * The following contraception is considered effective: Intrauterine device, hormonal contraceptives such as birth control pills, implants, contraceptive patch, vaginal ring, and contraceptive injection.

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Conditions

The condition(s) this trial relates to.

Encopresis

As listed by the trial registrant

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

Faecal incontinence Faecal incontinence with faecal urgency

Contacts and locations

Locations

  • Vall d'Hebron University Hospital

    Barcelona, 08035, Spain

More trials for these conditions

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