RecruitingNot ApplicableNCT06285292

Prospective and Comparative Evaluation of a Medical Device Composed of a Perineal Probe Connected to a Mobile Application in the Management of Stress Urinary Incontinence.

Sponsor

Nantes University Hospital

Enrollment

138 participants

Start Date

Nov 25, 2024

Study Type

INTERVENTIONAL

Conditions

Urinary Incontinence

Summary

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called EMY for people with urinary incontinence. The study is currently recruiting participants at 1 location. People eligible for this study include women aged 18 Years to 60 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEEMY

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