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Effective in a single-blinded, multicenter, randomized, sham controlled, clinical trial.

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.

Of patients participating in the clinical trial:

92.3%

quickly became skillful with device

88.5%

are satisfied

88.5%

would recommend to a friend

Randomized Controlled Trial Evaluating Efficacy & Safety of a Novel Stress Incontinence Device

Get the details

Clinical trials took place at:

Physician Roundtable

How Yōni.Fit Compares to Modern SUI Treatments

Featuring an unscripted conversation between principal investigators from the clinical trial and the Yōni.Fit Chief Medical Officer.

What they are saying:

Nearly 3 in 4 women worldwide suffer from SUI, and for years have been suffering in silence because the treatments can be perceived as intimidating or invasive.

Assistant Professor of Urology & Gynecology/Obstetrics, NYU

Patients expressed being happy with the opportunity for a non-surgical option for the treatment of SUI. Options in this space are currently limited.

Yōni.Fit Clinical Trial Investigator

This has changed such a huge part of my life. I am truly grateful.

Yōni.Fit Clinical Trial Patient

Overall, patients tolerated the therapy well. Patients also expressed being happy with the opportunity for a non-surgical option for the treatment of stress incontinence. Many patients expressed the desire to purchase the product.

Yōni.Fit Clinical Trial Investigator