Strasbourg University Hospitals
Strasbourg, 67091, France
NCT Number: NCT03985345
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.
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Notify Me18 year and older
Female
Interventional
Not applicable
Strasbourg, 67091, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Free use of EMY and its mobile application for 10 minutes during 5 different days per week.
Time frame: 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).
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.
Time frame: 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).
Time frame: 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.
Time frame: The PGI-I questionnaire will be completed at visit Month3 (3 monhs after inclusion visit).
Time frame: The questionnaire of interest will be completed at visit Month3 (3 monhs after inclusion visit).
University Hospital, Strasbourg, France
Other
Acronym: Reduc@home
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