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Can a High-Tech probe help women stop leaking urine?

NCT ID NCT03985345

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 connected biofeedback probe called EMY, which women use at home with a mobile app to train their pelvic floor muscles. The goal was to see if it improves quality of life for women with stress urinary incontinence—leaking urine when coughing, sneezing, or exercising. Fifty-five women who had given birth at least six months earlier used the device for 10 minutes, five days a week. The study measured changes in quality of life and how well women stuck to the training plan.

What this could mean

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

Active substance
intravaginal biofeedback probe (EMY) with mobile app
What this could lead to
If it works, this could offer a non-surgical, home-based option to help women manage stress urinary incontinence and improve their quality of life.
What could go wrong
This is a small, completed study with only 55 participants and no control group, so results may not be widely applicable. The device requires consistent use and may not work for everyone.

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

55 people

The number who actually took part.

Started

Sep 2019

Finished

Sep 2020

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: * Women with urinary leakage, at least once a week or more since more than 3 months * Women aged 18 and over, no upper age limit * Patient having given birth since 6 months minimum * Patient able to do an effective voluntary contraction and avoiding abdominal synergy and apnea during contraction (attested by the health professional partner who leads the patient to the study) * Patient who has responded favorably to a perineal reeducation with at least 2 sessions (attested by the health professional partner who leads the patient to the clinical study), rehabilitation of stress urinary incontinence or mixed incontinence with predominance of stress urinary incontinence * Signed informed consent form * Effective contraception throughout the study (declarative) * The patient must have a smartphone running at least the Android 5 and iOS 8 versions * The patient must know how to read and write French Exclusion Criteria: * Patient practicing any other perineal reeducation during the study period * Patient with neurological disease or congenital malformation, urinary incontinence or prolapse treated surgically or medically or perineal hypoesthesia or local conditions that prohibit the use of an intravaginal device * Patient with an urge urinary incontinence or mixed urinary incontinence with a predominance of urgency. * Contraindication to the use of the medical device * Patient with Genito-urinary cancer (in the last 5 years) * Patient with extra-uretral "incontinence" (fistula, ectopic ureter) * Patient with severe urinary retention * Patient carrying a sacral neuromodulation case * Subject in exclusion period (determined by previous or current study) * Impossibility to give the patient clear information (patient in emergency situation, patient with difficulties for understanding, ...) * Patient under the protection of justice * Patient under guardianship or curatorship * Pregnancy (positive urine test) * Breastfeeding patient

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Conditions

The condition(s) this trial relates to.

female stress incontinence Urinary Incontinence, Stress

As listed by the trial registrant

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

Contacts and locations

Locations

  • Strasbourg University Hospitals

    Strasbourg, 67091, France

More trials for these conditions

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