Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Could a pacemaker for the pelvis end double incontinence?

NCT ID NCT07212387

Disease control Sponsor: University Hospital Ostrava 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at whether a device that sends mild electrical pulses to the sacral nerve can help people who have both fecal and urinary incontinence at the same time. The device is already approved for each condition separately. Thirty adult women will try the treatment and report how well it works using symptom diaries and questionnaires. The goal is to reduce leakage episodes and improve daily life.

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

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2025

An estimate. Start dates often move.

Expected to finish

Dec 2029

An estimate. End dates often move.

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

18 years and older

Sex

Female participants only

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: * Adult women over 18 years of age * Consent to participate in the study * Willingness to undergo examination, treatment and follow-up according to the protocol * DI symptoms characterized by: * Grade III fecal incontinence (patient is unable to consciously hold in wind, loose or hard stools) * At least 2 episodes of fecal incontinence during the week (according to bladder and bowel diary) * At least 1 episode of involuntary urine leakage per day (according to bladder and bowel diary) * Total score of the ICIQ-UI SF questionnaire * DI symptoms for more than 6 months * Failure of previous conservative treatment Exclusion Criteria: * Rapidly progressing neurological diseases * Known severe congenital malformations of the anorectum and/or lower urinary tract * Presence of a foreign body in the urinary tract - urolithiasis, urinary catheter, ureteral stent * Pregnancy, lactation * Active urinary tract infection * Active malignant disease * Clinically significant pelvic organ prolapse * Active inflammatory bowel disease (Crohn's disease, ulcerative colitis) * In the case of an associated lesion of the external anal sphincter, a defect greater than 90 degrees * Previous pelvic radiotherapy less than 12 months prior to study enrolment * Previous pelvic organ descent surgery less than 12 months prior to study enrolment * Previous stress urinary incontinence surgery less than 12 months prior to study enrolment * Previous childbirth less than 12 months prior to study enrollment * Anatomical malformations of the sacrum that preclude implantation of the SNM electrode * Low patient compliance * Inability to control the neurostimulator

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Double incontinence are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Encopresis Urinary Incontinence

As listed by the trial registrant

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

Double incontinence Faecal incontinence Urinary incontinence

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University Hospital Ostrava

    Ostrava, Moravian-Silesian Region, 708 52, Czechia

More trials for these conditions

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