An interventional study of EMY in Urinary Incontinence, sponsored by Nantes University Hospital. Recruiting at 1 site in France. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-06-25.
Sponsored by Nantes University Hospital · Not applicable, Interventional, and Treatment
Stress urinary incontinence (SUI) affects around 40% of women and has a major impact on quality of life. The gold standard for the treatment of SUI is pelvicfloor rehabilitation, but this presents constraints in terms of availability of healthcare professionals, as well as organization and travel for patients. Innovative devices offer self-training exercises for the pelvicfloor, thus promoting motivation and adherence to treatment. The hypothesis of this study is to prove that the use of a pelvicfloor medical device combined with 2 rehabilitation sessions is not inferior to pelvic-perineal rehabilitation.
Two groups will be studied:
Recruitment will be carried out with the help of healthcare professionals. The investigators involved in the study will be physiotherapists specializing in pelvic-perineal rehabilitation.
983 studies on the registry are indexed under Urinary Incontinence; 180 are open to participants now.
This study's planned enrollment of 138 is above the median of 66 across 739 interventional studies indexed under Urinary Incontinence.
Browse Urinary Incontinence studies →Nantes University Hospital is the lead sponsor of 839 studies on the registry; 195 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
2 rehabilitation between M0 and M2 and pelvic-perineal exercises with the EMY device on 3 different days a week, for 15 minutes, over a period of 3 months.
Device: EMY
15 sessions of pelvic floor rehabilitation (gold standard)
Patients in the "intervention" group (rehabilitation with the EMY medical device) will undergo 2 rehabilitation sessions with a physiotherapist trained in pelviperineology between M0 and M2. The aim of these sessions will be to learn proper perineal contraction and combat the deficits identified during the physiotherapist's assessment. They will have to perform pelvic-perineal re-education exercises with the EMY device on 3 different days a week, for 15 minutes, over a period of 3 months. Then, for a further 3 months, their program can be modified for free, on-demand use (e.g. 2 x 10 minutes per week). After the main criterion at M6, they will be free to modify their rehabilitation program in the application according to their symptoms, and follow their program until the end of the study
Also known as: pelvic-perineal probe
Urinary symptoms using the ICIQ-UI SF questionnaire
The non-inferiority of 2 sessions of pelvic floor rehabilitation associated with the use of the EMY medical device compared with 15 sessions of pelvic floor rehabilitation (gold standard) on the urinary symptoms score at 6 months will be assessed using the ICIQ-UI SF questionnaire.
Time frame: 6 months
Quality of life using the I-QoL questionnaire
changes in quality of life will be studied using the validated I - QoL questionnaire
Time frame: 0 month, 1 month, 3 months, 6 months, 12 months
Urinary symptoms using the ICIQ-UI SF questionnaire
changes in urinary symptoms will be studied using the validated ICIQ-UI SF questionnaire
Time frame: 0 month, 1 month, 3 months, 12 months
Cost-utility ratio using the EQ-5D questionnaire
The cost/utility ratio will be studied using the cost/QALY ratio. The costs will relate to the consumption of reimbursed or non-reimbursed care (medical and paramedical consultations, hospitalization, drug treatment, absorbent pads, pessaries, etc.). QALYs will be estimated on the basis of responses to the validated EQ-5D 5L questionnaire.
Time frame: 0 month, 1 month, 3 months, 6 months, 12 months
Qualitative component
the qualitative component will consist of questionnaires evaluating : * consumption of care at M0, M1, M3, M6 and M12 ; * ease of access to care at M1 ; * treatment satisfaction with the standardized PGI-I questionnaire and the question "do you recommend your treatment to a friend ?" at M3; * treatment adherence using a diary and a Likert scale between M0 and M3
Time frame: 1 month, 3 months, 6 months, 12 months
Started Nov 2024 (actual). Primary completion is estimated for Nov 2026, 24 months after the start.
Of 301 non-industry interventional studies with no phase under Urinary Incontinence, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 37. This study's planned 24 months is above that.
Counting every sponsor, half of 364 studies reached it within 15 months; a quarter within 7 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
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