What is Flyte™?
Flyte is a simple, effective in-home treatment for stress urinary incontinence (SUI), designed to strengthen and treat weakened pelvic floor muscles to substantially improve bladder leaks when used as directed for 5 minutes per day for 6 weeks, the standard treatment time.
What is the story of Flyte?
Flyte was originally developed by physicians at the Arctic University of Norway and other experts in gynecology, muscle rehabilitation and urinary incontinence treatments. Two clinical trials studied the safety and effectiveness of Flyte, in Norway and the United States. The US study is one of the largest multi-center, randomized, double-blind study for an in-home stress urinary incontinence treatment to date. Flyte is now available in the United States and was cleared by the FDA in July 2020.
How does Flyte work?
Flyte helps women strengthen weak pelvic floor muscles to reduce bladder leaks – both the frequency and volume of urine.
The Flyte wand is placed in the vagina and delivers a series of mechanical pulses while you contract (squeeze or tighten) your pelvic floor muscles during a 5-minute per day, six-week treatment.
Flyte promotes a healing response within the cells of the pelvic floor muscles, restoring strength and bladder control. This is called mechanotherapy — the Flyte wand, mechanical pulses and muscle contractions working together to restore your pelvic floor.
Is Flyte effective?
Flyte reduces bladder leaks — both the frequency of episodes and volume of urine — in women with mild, moderate or severe stress urinary incontinence.
In clinical trial, most women using Flyte were dry or near dry in 2 - 12 weeks. For many women, Flyte’s benefits are life changing.
Is Flyte safe?
Flyte is a proven safe, non-surgical treatment for stress urinary incontinence.
Who can use Flyte?
Flyte is designed to strengthen weak pelvic floor muscles, which has been found to help women with stress urinary incontinence (SUI). You should be able to commit to using the device for 5 minutes per day for the standard six-week treatment time. You should also be OK with the idea of using a non-invasive, intravaginal device in the privacy of your home. Women who experience pelvic pain, pain with intercourse or have trouble using tampons may not be good candidates for Flyte. Whether your bladder leakage is mild, moderate or severe, Flyte may be able to help restore bladder control, reducing or eliminating leaks and the need for pads.
Does Flyte help women who have other forms of incontinence?
Flyte was clinically studied in women with SUI — women who leak when they cough, laugh, sneeze, exercise, or lift things. Flyte has not been studied to treat other forms of incontinence. If you are suffering from bladder leaks, we encourage you to talk with your doctor to understand what’s causing it and to discuss appropriate treatment options. There are many simple, non-surgical solutions for bladder leaks.
Who is not a good candidate for Flyte?
Do not use Flyte if you:
- Are under 21 years of age
- Have given birth in the past 6 weeks
- Have had genitourinary or pelvic surgery in the past 6 weeks
- Have had vaginal surgery within the past 3 months
- Have experienced unusual or unexpected vaginal bleeding in the past 6 months
- Experience pain or a burning sensation when you urinate, which could indicate a urinary tract infection
- Experience vaginal discharge that has an odor, irritation, soreness, or itching, which could indicate a vaginal infection
- Have been diagnosed by your doctor with a severely dry vagina
- If you have a sensitivity or allergy to silicone
Ask your doctor before using Flyte if you:
- Are pregnant
- Experience pain during sexual intercourse or when inserting a tampon or tampon-like device
- Often have trouble keeping in a tampon or tampon-like device
How can I get Flyte?
Flyte is newly FDA cleared. There are two ways to buy Flyte — one product, available with or without a prescription.
- Flyte is available directly from Pelvital without a prescription. Call us at 866-735-8482 or buy online here.
- Flyte is also available by prescription through a few healthcare professionals (coming soon!) in the Minneapolis/St. Paul MN area during our limited market release. Some healthcare professionals are offering telemedicine consults.
How much does Flyte cost? Is it covered by insurance?
The retail cost of Flyte is $649 when purchased from Pelvital.
Flyte is not currently covered by insurance. If you have money in a flexible spending account or a health savings account through your employer-based health insurance, you may be able to use this money to help pay for and purchase Flyte from a medical provider.
Why is Flyte more expensive than some other options available online?
Unlike most pelvic floor devices available online, Flyte is more than a Kegel trainer. It offers both biofeedback and treatment using mechnotherapy, leveraging the body's natural healing response to strengthen the pelvic floor muscle. Flyte is a treatment backed by 15 years of research and development including rigorous clinical studies to prove it is safe and effective.
Data on file at Pelvital
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