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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:

Logos for clinical trials locations: Stanford, NYU and Jefferson

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