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Clinical Trial 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.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT06285292
Study type Interventional
Source Nantes University Hospital
Contact Thibault THUBERT, PHD
Phone 02.53.48.24.43
Email thibault.thubert@chu-nantes.fr
Status Not yet recruiting
Phase N/A
Start date June 2024
Completion date June 2026

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