Frequently Asked Questions
How does Yōni.Fit work?
Yōni.Fit is inserted similarly to a tampon or cup, but it places gentle pressure on the bladder neck to prevent involuntary leaks caused by Stress Urinary Incontinence. The soft and flexible material is easy for the patient to insert and remove independently, and 100% of patients in our clinical trials were able to fit themselves. Yōni.Fit also collects menstrual flow and discharge, making it the first and only dual-purpose device that spans continence and period care.
What is the Yōni.Fit device made of?
Yōni.Fit is made of a soft, flexible, medical-grade silicone.
What were the most common side effects of Yōni.Fit?
All adverse events in the clinical trial were mild to moderate. Mild vaginal spotting and vaginal discomfort were the most common side effects. The majority of the adverse events were reported during the fitting phase, and we saw a significant decrease once the patient found the correct size.
How do I prescribe Yōni.Fit?
You can either e-prescribe here or use our fax sheet here.
How long can my patients use the Yōni.Fit device?
Up to 12 hours per day for up to 30 uses.
What kind of clinical evidence does the Yōni.Fit have?
Is there a peer-reviewed publication about the trials?
Yes, our peer reviewed publication is available here in Urogynecology.
Can patients use the Yōni.Fit device with an IUD?
Yes! Patients in the clinical trials that had an IUD were successful using the Yōni.Fit.
Who can benefit from a Yōni.Fit?
Most women who experience stress urinary incontinence can benefit from Yōni.Fit. Women who are childbearing age, sexually active, and looking forward to returning to specific activities that SUI has impacted tend to report the highest levels of satisfaction. In our recent clinical trial, 96.3% of patients reported success using the device.
Can women who have pelvic organ prolapse use Yōni.Fit?
Yes, in our clinical trials, women with up to stage 2 pelvic organ prolapse had success using Yōni.Fit. The device was not studied in patients with greater than stage 2 prolapse, however you may prescribe at your discretion.
How do I get a Provider Kit for my office?
To learn more about the Provider Kit, visit this page. Complete and submit the form and we’ll be in contact to ship you a Provider Kit or schedule a virtual in-service here and we will send a complimentary welcome kit to have on hand for the discussion.
How do I determine the right size for my patients?
We made a helpful video here that shows you exactly how to take a mid-vaginal width measurement during a pelvic exam and use the provider instructions to determine the right size and Fit Kit prescription. For patients that do not want a vaginal exam, self-sizing kits are available.
What is the difference between the different Fit Kits?
The Yōni.Fit comes in six different sizes which are organized into five different fit kit options:
- Fit Kit 1 (Purple): Includes sizes 1 (34 mm) and 2 (38 mm)
- Fit Kit 2 (Teal): Includes sizes 3 (42 mm) and 3.5 (45mm)
- Fit Kit 3 (Pink): Includes sizes 4 (48 mm) and 5 (52 mm)
- Telehealth/ Self-sizing Kit 4 (Silver): Includes sizes 1, 2 and 3
- Telehealth/self-sizing Kit 5 (Gold): Includes sizes 3.5, 4, and 5
Every fit kit includes a cleaning brush and for a limited time, may also include a free carrying case.
Can I prescribe the Yōni.Fit via telemedicine?
Yes, the self-sizing kits were specifically designed for patients that prefer to fit themselves at home. 100% of the patients in our clinical trials were able to find their correct size using the kit.
What if my patients have questions I can’t answer?
You can direct them to a variety of resources we created just for them:
- Patient FAQs Click Here for Patient FAQs
- Instructions for Use Click here to view IFU
- Patient helpline: 1-844-YONIFIT (844-966-4348)
Is Yōni.Fit covered by insurance?
Yes, Yōni.Fit should be covered by all major commercial and government insurance plans. Depending on the pharmacy, the patient may need to file individually with their insurance company for coverage.
Are there any contraindications for the Yōni.Fit?
Yōni.Fit is intended for women 18+ with stress urinary incontinence. It may be used for SUI predominant mixed incontinence but should not be used for urge urinary incontinence, during pregnancy, before a patient is cleared for vaginal insertion following childbirth, or when the patient has symptoms of a UTI or vaginal/vulvar infection. Please review the full Instructions for Use for all contraindications, warnings and precautions.
Do providers need to fit or sterilize Yōni.Fit in the office?
No. Yōni.Fit is designed to be patient-fit. Providers measure the patient’s mid-vaginal width and use that measurement to determine the appropriate Fit Kit. The patient receives the prescribed Fit Kit at home and tries the included sizes to determine which provides the best fit and comfort. Because Yōni.Fit is not inserted by the provider for fitting, there is no need to sterilize or autoclave Yōni.Fit devices in the office.
How can a pelvic floor therapist recommend Yōni.Fit?
Have your patient visit Yōni.Fit.com and complete the prescription request form. They can provide their prescribing physician’s information, such as their OB/GYN or PCP, and the Yōni.Fit team will contact the physician directly to obtain authorization. Once the prescription is approved, Yōni.Fit will coordinate fulfillment and shipping directly to the patient.
