Prospective Evaluation of the Connected EMY Biofeedback Probe in the Management of Stress Urinary Incontinence. (Reduc@home)
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|ClinicalTrials.gov Identifier: NCT03985345|
Recruitment Status : Recruiting
First Posted : June 13, 2019
Last Update Posted : March 9, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Stress Urinary Incontinence||Device: intravaginal device (probe) EMY||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Evaluation of the Connected EMY Biofeedback Probe in the Management of Stress Urinary Incontinence.|
|Actual Study Start Date :||September 2, 2019|
|Estimated Primary Completion Date :||December 9, 2021|
|Estimated Study Completion Date :||December 9, 2021|
|Experimental: EMY Probe||
Device: intravaginal device (probe) EMY
Free use of EMY and its mobile application for 10 minutes during 5 different days per week.
- Contilife questionnaire [ 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.
- The patient compliance to 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). ]
- The urinary scores [ 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. ]
- The interest of using the EMY connected perineal device in the context of stress urinary incontinence [ Time Frame: 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 [ Time Frame: The questionnaire of interest will be completed at visit Month3 (3 monhs after inclusion visit). ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03985345
|Contact: Eric DEMONSANT||+33 3 88 11 54 email@example.com|
|Strasbourg University Hospitals||Recruiting|
|Strasbourg, France, 67091|
|Contact: Aline HOST 03 69 55 34 04 ext +33 firstname.lastname@example.org|