New gadget aims to treat leaky bladder from home
NCT ID NCT06285292
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a medical device (a perineal probe connected to a mobile app) for women with stress urinary incontinence. Participants use the device at home for 15 minutes, three times a week, plus two sessions with a physiotherapist. The goal is to see if this approach works as well as the standard 15 physiotherapy sessions. The trial enrolls 138 women aged 18–60 with moderate to very severe symptoms.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- pelvic-perineal probe (EMY device) with mobile application
- What this could lead to
- If successful, this could offer a convenient home-based option for managing stress urinary incontinence, reducing the need for frequent clinic visits.
- What could go wrong
- This is a non-inferiority trial, so the device may not be as effective as standard therapy. The study is relatively small (138 participants) and results may not apply to all patients.
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 138 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Nov 2024
- Expected to finish
-
Nov 2026
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 to 60 years
- 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 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: * Patients with moderate, severe or very severe stress urinary incontinence or mixed stress urinary incontinence (according to ICIQ-UI SF questionnaire score: moderate (6-12), severe (13-18) and very severe (19-21)) * Patient aged between 18 and 60 * Patient with a quality of life score measured with the I-QoL questionnaire less than or equal to 70 (score measured from 0 to 100, with poor quality of life: 0-35; average quality of life: 36-70; good quality of life: 71-100) * Not to have given birth in the last 6 months (to avoid post-partum physiological recovery) * Signed informed consent * Effective contraception throughout the study (declarative) * Patient must have a smartphone running at least Android 7 and iOS 12 * Patient must be able to read and write French Exclusion Criteria: * Patients with mild stress urinary incontinence or mixed stress urinary incontinence (ICIQ-UI SF score: mild (1-5)) * Patient with a quality of life score above 70 (according to the I-QoL questionnaire: good quality of life: 71-100) * Patient undergoing other pelvic-perineal rehabilitation during the study period * Patients with neurological disease or congenital malformation, surgically or medically treated urinary incontinence or prolapse, perineal hypoesthesia or local conditions prohibiting the use of an intravaginal catheter * Infection of the bladder or vagina, or any symptoms associated with infection (itching, pain on urination or fever) * Contraindications to the use of the medical device * Anatomy making catheter placement difficult or impossible; in the case of prolapse, specialist advice is recommended. * Hemorrhage * Patients with genitourinary cancer (within the last 5 years) * Patients with extra-urethral "incontinence" (fistula, ectopic ureter) * Patients with severe urinary retention * Patient with vesico-ureteral reflux * Patients with hypoactive bladder * In case of peripheral denervation in the pelvic-perineal area, specialist advice is recommended * Patients wearing a sacral neuromodulation device * Patients in an exclusion period (determined by a previous or current study) * Impossibility of giving the subject clear information (subject in an emergency situation, difficulties in understanding the subject, etc.) * Patient under court protection * Patient under guardianship or curatorship * Pregnancy (positive pregnancy test) * Breastfeeding (as the hormonal impregnation caused by breastfeeding has a negative impact on perineal tone) * Use of Huawei and Oppo smartphones
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Stress urinary incontinence are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
-
CHU de Nantes
RECRUITINGNantes, 44093, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Shoes that train your pelvic floor without you knowing
- Estrogen drop may hold clue to bladder leaks in women with spinal cord injury
- Bladder leaks may signal frailty in older adults
- Can your own blood help stop leakage? a new trial investigates
- A gentler catheter may cut infection risk for women in hospitals
- Can a Full-Body rehab program help children stop wetting?