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: * the control group will undergo 15 sessions of pelvic-perineal rehabilitation, corresponding to the gold standard. * the intervention group will use the medical device 3 times a week for 15 minutes over a 3-month period, in addition to 2 rehabilitation sessions. The participant will then be able to modify her program according to her symptoms. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
138
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
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.
Time frame: 6 months
Quality of life using the I-QoL questionnaire
changes in quality of life will be studied using the validated I - QoL questionnaire
Time frame: 0 month, 1 month, 3 months, 6 months, 12 months
Urinary symptoms using the ICIQ-UI SF questionnaire
changes in urinary symptoms will be studied using the validated ICIQ-UI SF questionnaire
Time frame: 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.
Time frame: 0 month, 1 month, 3 months, 6 months, 12 months
Qualitative component
the qualitative component will consist of questionnaires evaluating : * consumption of care at M0, M1, M3, M6 and M12 ; * ease of access to care at M1 ; * treatment satisfaction with the standardized PGI-I questionnaire and the question "do you recommend your treatment to a friend ?" at M3; * treatment adherence using a diary and a Likert scale between M0 and M3
Time frame: 1 month, 3 months, 6 months, 12 months
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