How an FDA-Cleared System Is Changing the Way We Treat Stress Urinary Incontinence
Stress Urinary Incontinence (SUI)— bladder leaks with sneezing, laughing, coughing, running, jumping, etc.—impacts millions of women across all stages of life. Whether you’re postpartum, perimenopausal, or simply sneezing too hard during allergy season, SUI can affect your confidence, your schedule, and your sense of control.
But here's the good news: medical technology is advancing, and we no longer need to rely on pads, guesswork around Kegels, bulking injections, or invasive surgeries. Flyte, an FDA-cleared treatment for stress urinary incontinence, is changing the way we treat SUI—offering fast, noninvasive, clinically proven results from the comfort of home. Research supports that pelvic floor muscle training (PFMT) significantly improves continence and quality of life [1], especially when enhanced by mechanotherapy, Flyte’s mechanism of action. [2,3]
Let’s dive into how mechanotherapy works, why FDA clearance matters, and how Flyte is leading the way in revolutionizing pelvic health.
Understanding Stress Urinary Incontinence
Stress Urinary Incontinence is defined as the involuntary leakage of urine during activities that increase abdominal pressure, such as coughing, laughing, sneezing, jumping, running, or lifting [4]. 62% of women have urinary incontinence [5], and SUI is the most common form of urinary incontinence in women [5,6]. Take our FREE Bladder Quiz to learn more about your type of urinary incontinence.
Key facts:
- On average, 62% of women over age 20 experience urinary incontinence (UI), with prevalence rates ranging from 37% to 83% depending on age and risk factors [5].
- UI is especially common after childbirth, during menopause, and as women age, with 83% of women aged 70 and above affected [5].
- UI is not a normal part of aging—and it is treatable. A Cochrane review confirms that PFMT can cure or improve symptoms of SUI, reducing leakage episodes and improving quality of life [1].
SUI occurs when the pelvic floor muscles and tissues that support the bladder and urethra weaken or lose tone. This can be due to:
- Pregnancy and childbirth (especially vaginal delivery)
- Hormonal changes in menopause
- High-impact exercise
- Aging and tissue laxity
- Obesity or chronic coughing
While it’s incredibly common, SUI is rarely discussed openly. Many women suffer in silence or assume bladder leaks are a “normal” part of being a mom or aging. However, studies show that SUI significantly impacts psychological, social, and sexual well-being, underscoring the need for effective treatments [7-9].
The truth: Bladder leaks are common—but they’re not normal. And they’re absolutely treatable with Flyte, an evidence-based, FDA-cleared prescribed in Family Medicine, OB/GYN, and urology.
Take the FREE Incontinence Quiz Now
Why FDA Clearance Matters
In a world full of wellness trends, social media ads, and “miracle” pelvic devices sold online, one designation stands out: FDA clearance.
What Does “FDA-Cleared” Actually Mean?
When the medical device is FDA 510(k) cleared, it means the FDA has accepted the information and data submitted by the manufacturer supporting the device is substantially equivalent to a predicate device being legally marketed in the US [10].
Substantial equivalence means the device, when compared to a legally marketed predicate device:
· has the same intended use as the predicate; and
· has the same technological characteristics as the predicate;
or
· has the same intended use as the predicate; and
· has different technological characteristics and does not raise different questions of safety and effectiveness; and
· the information submitted to FDA demonstrates that the device is as safe and effective as the legally marketed device.
This involves:
- Reviewing clinical and non-clinical studies and data to confirm efficacy and safety
- Requiring manufacturing and quality standards
- Comparing the device to others on the market for substantial equivalence
There are three classifications of medical devices with the FDA [10]:
Class I: Low risk, FDA-listed or FDA-registered (e.g. bandages, examination gloves, tongue depressor)
§ FDA knows the device is being sold but has not been reviewed for its safety and use
Class II: Moderate risk, goes through FDA-clearance (e.g. Flyte, blood pressure monitors, wheelchairs)
§ Devices found to be “substantially equivalent” to similar products with FDA clearance
Class III: High risk, goes through FDA-approval (e.g. pacemakers, replacement heart valves, medications)
§ Thorough FDA review as device may pose substantial risk, illness, or may be crucial in supporting life
Why You Should Care
- Safety: FDA clearance ensures the product doesn’t cause harm when used as directed.
- Efficacy: It’s proven to do what it claims—such as treating stress urinary incontinence. For example, Flyte’s clinical trials showed 91% of patients responded to treatment [3].
- Credibility: It means the product information and data submitted has been reviewed by a trusted federal health authority and must continue to follow a set of rigorous quality regulations.
Unlike generic products or wellness gadgets, FDA-cleared pelvic floor systems meet rigorous standards. This sets them apart from untested devices marketed online.
Introducing Flyte: The FDA-Cleared Breakthrough in Pelvic Floor Health
Flyte is an at-home pelvic floor treatment system that’s changing the game for women with stress urinary incontinence. It’s FDA-cleared, clinically proven, and designed by pelvic floor experts to restore continence in just 5 minutes a day. Developed by physicians and researchers with association to the Arctic University of Norway, Flyte leverages mechanotherapy—a novel approach that leverages the body’s natural healing response to strengthen the pelvic floor muscles [2,3,11].
What Makes Flyte Different?
- Noninvasive: No surgery, no downtime, no pain.
- Convenient: Use from home—in just 5 minutes a day, for 6 weeks.
- Clinically Proven: In clinical trial, 82% of women achieved continence in 6 weeks, with 77% maintaining results 2 years later [2].
- Developed and Prescribed by Clinicians: Designed and tested by doctors and researchers, prescribed by Family Medicine, OBGYN, Women’s Health, Urology, Pelvic floor therapists, and more.
- Long-lasting Results: Treats the root cause—pelvic floor weakness—not just the symptoms.
Flyte uses a comfortable intravaginal wand that delivers a gentle, therapeutic mechanical oscillation while you perform pelvic floor contractions. This mechanotherapy approach stimulates cellular-level tissue repair and enhances neuromuscular memory [2]. Unlike Kegels alone, which are performed incorrectly by up to 76% of women [12], Flyte provides real-time muscle re-education with science-backed results.
A 2020 study demonstrated that Flyte’s mechanotherapy superimposed on guided Kegels significantly reduced bladder leaks (mild, moderate, and severe >500g/24 hours) in 71% of women within 2–12 weeks [3], with 91% of women responding to treatment.
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Comparing Treatment Options: Why Flyte Makes Sense
If you’re leaking, you’ve likely been told to “just do more Kegels,” “try a pad,” or “consider surgery.” Here’s how Flyte compares to common options, backed by research:
| Treatment | Pros | Cons |
| Pads/Panty Liners | Easy to use, accessible | Costly over time ($750/year on average) [13], only masks symptoms. Increased risk of UTIs [14] |
| Kegels | Noninvasive, free | Often done incorrectly, takes months to see results. 56% success rate from 12 weeks to 6 months [15]. |
| Surgery (Sling, Bulking Agents) | High success rate (up to 80–90%) [14] | Invasive, requires downtime, potential complications like perforation, pain, bleeding, infection, dyspareunia [16] |
| Flyte | Fast, noninvasive, FDA-cleared, at-home, effective in 2-12 weeks [2,3,11] | Requires consistent daily use for 6 weeks |
Pads are a short-term coping mechanism. Surgery is effective but carries risks, including bladder perforation, continued incontinence, infection, painful intercourse (dyspareunia), bleeding, scarring, nerve and/or muscle issues, need for additional surgeries, etc [16]. Kegels, while beneficial, are less effective without supervision, and compliance is low [1]. Flyte bridges the gap, offering a noninvasive, clinically proven path to dryness with high patient satisfaction [2,3,11].
Real Women. Real Results.
Don’t just take our word for it—women across the country are experiencing life-changing results with Flyte.
“I’ve lived with this issue for over 10 years — I can’t believe only a few weeks into the Flyte program and I am seeing such amazing results - and without surgery! This is life changing.”— Lisa
“I am so excited to be free from constantly paying for and wearing pads - but even more excited to be dating again! [Flyte is] totally worth it.”— Carrie
“I used Flyte for six weeks and stopped leaking! That was over a year ago and I haven’t had to use it since. I now get to be active without leaks and have returned to playing pickleball.”— Kristen
“I am so glad [Flyte] was an option for postpartum use. After 4 weeks of Flyte my bladder leaks went away! I was able to get back to working out without being nervous and had so much more confidence.”— Amy
“I want everyone to know how much success I had with the Flyte treatments. I've had problems for 30 years and using up to 3 packs of pads a week... after 6 weeks...I was not leaking like I was! It was a miracle! And I am able to exercise again!”— Sharon
These testimonials align with clinical data showing Flyte’s effectiveness across mild, moderate, and severe SUI, with 91% of users reporting reduced leakage in the U.S. trial [3].
The Future of SUI Treatment
As more women speak openly about pelvic health, the demand for effective, convenient solutions is growing. Research highlights the need for noninvasive, accessible treatments that improve quality of life [11]. The future of SUI treatment is:
- Noninvasive: Avoiding surgery where possible
- Clinically backed: Supported by robust evidence
- Accessible from home: Reducing barriers to care
- Integrated with expert support: Offering expert guidance, Flyte staffs Doctor of Physical Therapy specialized in pelvic health to support you
Flyte is at the forefront of this change. It’s not just a device—it’s a movement toward empowering women to reclaim control of their bodies and lives.
What to Look for in a Pelvic Floor Device
Not all pelvic floor gadgets are created equal. Before choosing a treatment, ask:
- Is it FDA-cleared?
- Is it clinically proven?
- Is it noninvasive and easy to use?
- Is there support or professional guidance?
If the answer isn’t yes to all four, keep searching. Flyte meets these criteria, ensuring safety, efficacy, and user support.
Questions? Connect with our Doctors of Physical Therapy
You Deserve Better Than Bladder Leaks
Whether you’re a mom chasing toddlers, a professional powering through meetings, a grandmother enjoying her golden years, or an active woman who wants to enjoy life without pads—you deserve to be leak-free.
You don’t need to accept bladder leaks as your “new normal.” With Flyte, you can:
- Restore your pelvic strength
- Reclaim your confidence
- Say goodbye to bladder leaks—for good
Talk to your doctor about Flyte or connect with Flyte’s on-staff pelvic health Doctors of Physical Therapy, and take the first step toward leak-free living!
References
1. Dumoulin, C., et al. (2018). Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women. Cochrane Database of Systematic Reviews. DOI: 10.1002/14651858.CD005654.pub4
2. Nilsen I, Rebolledo G, Acharya G, Leivseth G. Mechanical oscillations superimposed on the pelvic floor muscles during Kegel exercises reduce urine leakage in women suffering from stress urinary incontinence: A prospective cohort study with a 2-year follow up. Acta Obstet Gynecol Scand. 2018 Oct;97(10):1185-1191. doi: 10.1111/aogs.13412. Epub 2018 Aug 2. PMID: 29923602.
3. Nakib N, Sutherland S, Hallman K, Mianulli M, R Boulware D. Randomized trial of mechanotherapy for the treatment of stress urinary incontinence in women. Ther Adv Urol. 2024 Feb 6;16:17562872241228023. doi: 10.1177/17562872241228023. PMID: 38328552; PMCID: PMC10848796.
4. Haylen, B. T., et al. (2010). An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Neurourology and Urodynamics, 29(1), 4–20. DOI: 10.1002/nau.20798
5. Patel UJ, Godecker AL, Giles DL, Brown HW. Updated Prevalence of Urinary Incontinence in Women: 2015-2018 National Population-Based Survey Data. Female Pelvic Med Reconstr Surg. 2022 Apr 1;28(4):181-187. doi: 10.1097/SPV.0000000000001127. Epub 2022 Jan 12. PMID: 35030139.
6. Minassian VA, Stewart WF, Wood GC. Urinary incontinence in women: variation in prevalence estimates and risk factors. Obstet Gynecol. 2008 Feb;111(2 Pt 1):324-31. doi: 10.1097/01.AOG.0000267220.48987.17. PMID: 18238969.
7. Franco MM, Pena CC, de Freitas LM, Antônio FI, Lara LAS, Ferreira CHJ. Pelvic Floor Muscle Training Effect in Sexual Function in Postmenopausal Women: A Randomized Controlled Trial. J Sex Med. 2021 Jul;18(7):1236-1244. doi: 10.1016/j.jsxm.2021.05.005. Epub 2021 Jun 27. PMID: 34187758.
8. Cheng S, Lin D, Hu T, Cao L, Liao H, Mou X, Zhang Q, Liu J, Wu T. Association of urinary incontinence and depression or anxiety: a meta-analysis. J Int Med Res. 2020 Jun;48(6):300060520931348. doi: 10.1177/0300060520931348. PMID: 32552169; PMCID: PMC7303787.
9. Bartolone SN, Sharma P, Chancellor MB, Lamb LE. Urinary Incontinence and Alzheimer's Disease: Insights From Patients and Preclinical Models. Front Aging Neurosci. 2021 Dec 17;13:777819. doi: 10.3389/fnagi.2021.777819. PMID: 34975457; PMCID: PMC8718555.
10. Premarket Notification 510(k) | FDA. Accessed June 1, 2025.
11. Fulker A, Kovela S, Mianulli M. Transvaginal mechanotherapy for stress urinary incontinence: Principles, cellular and neuromuscular mechanisms of action, and comparison to current gold standard treatments. Continence Reports. 2025 Mar;13C. 100077. doi: https://doi.org/10.1016/j.contre.2024.100077.
12. Kandadai P, O'Dell K, Saini J. Correct performance of pelvic muscle exercises in women reporting prior knowledge. Female Pelvic Med Reconstr Surg. 2015 May-Jun;21(3):135-40. doi: 10.1097/SPV.0000000000000145. PMID: 25349943.
13. Subak LL, Brubaker L, Chai TC, Creasman JM, Diokno AC, Goode PS, Kraus SR, Kusek JW, Leng WW, Lukacz ES, Norton P, Tennstedt S; Urinary Incontinence Treatment Network. High costs of urinary incontinence among women electing surgery to treat stress incontinence. Obstet Gynecol. 2008 Apr;111(4):899-907. doi: 10.1097/AOG.0b013e31816a1e12. PMID: 18378749; PMCID: PMC2593129.
14. Ragnhild Omli, Liv Heidi Skotnes, Ulla Romild, August Bakke, Arnstein Mykletun, Esther Kuhry, Pad per day usage, urinary incontinence and urinary tract infections in nursing home residents, Age and Ageing, Volume 39, Issue 5, September 2010, Pages 549–554, https://doi.org/10.1093/ageing/afq082
15. Jundt K, Peschers U, Kentenich H. The investigation and treatment of female pelvic floor dysfunction. Dtsch Arztebl Int. 2015 Aug 17;112(33-34):564-74. doi: 10.3238/arztebl.2015.0564. PMID: 26356560; PMCID: PMC4570968.
16. Ford AA, Rogerson L, Cody JD, Ogah J. Mid-urethral sling operations for stress urinary incontinence in women. Cochrane Database Syst Rev. 2015 Jul 1;(7):CD006375. doi: 10.1002/14651858.CD006375.pub3. Update in: Cochrane Database Syst Rev. 2017 Jul 31;7:CD006375. doi: 10.1002/14651858.CD006375.pub4. PMID: 26130017.