Can a High-Tech probe help women stop leaking urine?
NCT ID NCT03985345
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
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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
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55 people
The number who actually took part.
- Started
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Sep 2019
- Finished
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Sep 2020
- Lead sponsor
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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
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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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 Hide 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Strasbourg University Hospitals
Strasbourg, 67091, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Shoes that train your pelvic floor without you knowing
- Can your own blood help stop leakage? a new trial investigates
- Could a blood flow drug strengthen pelvic muscles to curb incontinence?
- Can ancient qigong movements fortify pelvic health after childbirth?
- Can a single dose of muscle cells hold up for years against stubborn incontinence?