Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| FIZIMED | UNKNOWN |
Not provided
Not provided
Not provided
After birth, the perineum has to be trained in order to recover its functions.
This study is designed to assess the quality of life evolution with the EMY connected device.
The secondary purposes are to evaluate patient compliance to the EMY probe, to observe the evolution of urine scores over the duration of the trial in order to consider a comparative study thereafter, and to evaluate the interest of using the EMY connected perineal probe in the context of stress urinary incontinence.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EMY Probe | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intravaginal device (probe) EMY | Device | Free use of EMY and its mobile application for 10 minutes during 5 different days per week. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Contilife questionnaire | A quality of life questionnaire will be used to follow the quality of life evolution for patients with stress urinary incontinence (UI) using the EMY device. | The change of the quality of life will be assessed : completion of Contilife questionnaire at the inclusion visit (Day 0), one month after inclusion visit (Month1), 2 months after inclusion visit (Month2) and 3 months after inclusion (Month3). |
| Measure | Description | Time Frame |
|---|---|---|
| The patient compliance to the EMY device | Patients will complete the tracking notebook each time they use the EMY device during 3 months of the clinical research study (from inclusion, until visit Month3). | |
| The urinary scores | The change in the urinary scores will be assessed. The ICIQ-SF questionnaire will be completed by patients at the inclusion visit (Day0) and on visits Month1, Month2 and Month3. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Strasbourg University Hospitals | Strasbourg | 67091 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34861424 | Background | Jochum F, Garbin O, Godet J, Ragueneau M, Meyer C, Billecocq S, Lecointre L, Akladios C, Host A. Prospective evaluation of the connected biofeedback EMY Kegel trainer in the management of stress urinary incontinence. J Gynecol Obstet Hum Reprod. 2022 Feb;51(2):102280. doi: 10.1016/j.jogoh.2021.102280. Epub 2021 Dec 1. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 18, 2025 | |
| Reset | Dec 11, 2025 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 18, 2025 | Dec 11, 2025 |
| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| The interest of using the EMY connected perineal device in the context of stress urinary incontinence | The PGI-I questionnaire will be completed at visit Month3 (3 monhs after inclusion visit). |
| The interest of using the EMY connected perineal device in the context of stress urinary incontinence | The questionnaire of interest will be completed at visit Month3 (3 monhs after inclusion visit). |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |