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| Name | Class |
|---|---|
| FIZIMED Company | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EMY (connected biofeedback medical device) | Experimental | 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. |
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| standard | No Intervention | 15 sessions of pelvic floor rehabilitation (gold standard) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EMY | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life using the I-QoL questionnaire | changes in quality of life will be studied using the validated I - QoL questionnaire | 0 month, 1 month, 3 months, 6 months, 12 months |
| Urinary symptoms using the ICIQ-UI SF questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thibault THUBERT, PHD | Contact | 02.53.48.24.43 | thibault.thubert@chu-nantes.fr | |
| Selma EL ANDALOUSSI, manager | Contact | 02.53.48.28.52 | selma.elandaloussi@chu-nantes.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nantes | Recruiting | Nantes | 44093 | France |
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changes in urinary symptoms will be studied using the validated ICIQ-UI SF questionnaire
| 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. | 0 month, 1 month, 3 months, 6 months, 12 months |
| Qualitative component | the qualitative component will consist of questionnaires evaluating :
| 1 month, 3 months, 6 months, 12 months |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| 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 |
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