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.

NANot yet recruitingINTERVENTIONAL
Enrollment

138

Participants

Timeline

Start Date

June 30, 2024

Primary Completion Date

June 30, 2024

Study Completion Date

June 30, 2026

Conditions
Urinary Incontinence
Interventions
DEVICE

EMY

"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"

All Listed Sponsors
collaborator

FIZIMED Company

UNKNOWN

lead

Nantes University Hospital

OTHER

NCT06285292 - 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. | Biotech Hunter | Biotech Hunter