A soft, non-surgical intravaginal device for the management of stress urinary incontinence (SUI).
Leaking affects about 2 in 3 women in the US*.
Now you have a fast, non-invasive, same-day treatment for your patients.
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.
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:
quickly became skillful with device
would recommend to a friend
Yōni.Fit is inserted in the vagina similarly to a tampon or menstrual cup, but it is designed to gently place pressure on the urethra to prevent involuntary leaking.
The soft and flexible medical-grade silicone is strong enough to prevent leaks while still allowing women to urinate voluntarily without removing the device.
(6 of them, to be exact.)
Yōni.Fit can be prescribed in your office and coming soon in January 2025, via telehealth. To find the right fit, you will need to perform a pelvic exam and follow the instructions in the video. A link to the Prescriber Instructions is below.
Coming January 2025
Patients will be able to self-fit the device if they decline a pelvic exam or you’re treating via telehealth. Prescribe Telehealth Kit 4, which includes the three smallest sizes of Yōni.Fit and they will be able to test each size at home. The three smallest sizes fit most women. If a patient finds those sizes are not sufficient, you can either prescribe Telehealth Kit 5 or individual sizes 3.5, 4, or 5 depending on the patient’s needs.
The Fit Kit displays all 6 Yōni.Fit sizes, allowing you and your patients to touch and feel for yourselves the soft, flexible material and see the patented crosshatch design.
Use the Fit Kit to show your patients how it works, how it feels, and how to use it.
Yōni.Fit is inserted in the vagina similarly to a tampon or menstrual cup, but it is designed to gently place pressure on the urethra to prevent involuntary leaking with laughing, coughing, sneezing or exercise. The soft and flexible material is strong enough to prevent leaks while still allowing you to pee voluntarily without removing the device.
Yōni.Fit is made of a soft, flexible, medical-grade silicone.
Vaginal spotting and vaginal discomfort were the most common side effects.
© 2024 Yōni.Fit.
