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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03985345
Other study ID # 6990
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2, 2019
Est. completion date September 9, 2020

Study information

Verified date March 2021
Source University Hospital, Strasbourg, France
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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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Study Design


Intervention

Device:
intravaginal device (probe) EMY
Free use of EMY and its mobile application for 10 minutes during 5 different days per week.

Locations

Country Name City State
France Strasbourg University Hospitals Strasbourg

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Strasbourg, France FIZIMED

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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).
Secondary 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).
Secondary 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.
Secondary 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).
Secondary 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).
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