Over half of women using the Yōni.Fit device saw over a 50% reduction in their 12-hour pad weights compared to the control device. Subjects collected pad weights over a period of 7 days, representing efficacy with regular daily activities.
Yōni.Fit reduced SUI episodes on voiding diary by at least 50% in almost all (96.3%) study patients.
Adverse events were mostly mild with zero device related serious adverse events.