For Healthcare Professionals

Clinically proven, first-line treatment for incontinence

Flyte is a first-of-its-kind, clinically proven, intravaginal home-use device that delivers mechanotherapy to the pelvic floor muscles to treat stress urinary incontinence caused by weak pelvic floor muscles. Mechanotherapy is an established medical treatment that has shown to be effective in the rehabilitation of muscles and other tissue by stimulating cellular responses that support the body's healing process. 

Flyte is backed by clinical data that demonstrates high efficacy with clinical benefit approaching surgery but at a much lower cost and without the surgical risks. As an easy-to-use, affordable, non-surgical treatment, Flyte has the potential to be first-line therapy for millions of women. Flyte is FDA cleared.

A 5-minute per day, 6-week standard in-home treatment

  • Made of medical-grade silicone
  • Sensors measure tone of the pelvic floor muscles at rest and in contraction
  • Transmits data to handheld biofeedback unit to provide visual feedback
  • Delivers two-part therapy: 1) preloads the muscle to enhance neuromuscular function 2) delivers mechanical transduction pulses 
  • Amplifies the benefit of a Kegel for faster results compared to pelvic floor muscle training (PFMT) alone
Small_Flyte3121_8
Small_Flyte3030_3

Treating through non-invasive mechanotherapy

Mechanotherapy uses non-invasive mechanical stimuli to a surface of the body to influence molecular, cellular and tissue structures and function via a process called mechanotransduction, ultimately leading to improve a function in the body.

Unlike other intravaginal, home-use devices that use apps to teach PFMT through biofeedback, Flyte offers both biofeedback and mechanotherapy-based treatment.

  • Flyte treats with mechanotherapy, which leverages the body’s natural healing response to strengthen the pelvic floor muscles.
  • During mechanotherapy, the Flyte intravaginal wand stimulates the pelvic floor through preloading the muscles and mechanical transduction pulses that provide biofeedback during Kegel contractions. 
  • The body responds at the cellular level  to the Flyte wand. These cellular responses promote structural changes in the body – a stronger pelvic floor – improving bladder control.
  • Flyte’s mechanotherapy amplifies the benefit of a Kegel, so patients see results much sooner compared to PFMT alone.

Clinical Evidence

A growing body of scientific evidence confirms that Flyteâ„¢ is a clinically effective, non-invasive treatment for women with stress urinary incontinence (SUI). Clinical studies have shown that Flyte provides statistically significant improvements in pad weight, voiding frequency, and quality of life (QoL).

Flyte was studied in patients in two different studies. Our first study was a single-arm, prospective study using an in-clinic, ultra-short perineal pad test. Our second study was a 119 patient, multi-center double blind, randomized trial using the 24-hour pad weight test. This study is currently underway (fully enrolled with interim results – patients will be followed for two years). Despite these very different testing methodologies, both studies showed statistically significant clinical improvements. 

Single Arm, Prospective Pilot Study

  • Pelvic floor training 5 mins/day for 4-6 weeks using Flyteâ„¢ (n=60 female SUI patients; mean age=47; all referred for surgery)
  • 1-hour standard volume stress tests
  • After 6 weeks, 82.9% of patients were continent (defined as ≤4g leakage)
  • Urine leakage decreased from a mean of 20.5g +/- 12.2g to 1.5g +/- 3.5g
  • Patients (n=36) followed for 2 years; 77% reported continued continence at the 2-year mark; none underwent surgery
Single Arm Prospective Pilot Study Graph

Randomized, Double Blind, Controlled, Multi-Center Study

  • Final enrollment: n=119 patients. 5 mins/day treatment sessions for 12 weeks
  • 24-hour pad weight tests
  • Control patients were crossed over to full intervention after 6 weeks
  • Within 2 - 12 weeks 71% of patients were dry or near dry
  • 71% achieved more than 50% reduction in pad weight in 12 weeks
  • At 6 weeks, 81% of patients were responders. At 12 weeks, 91% of patients were responders (defined as more than 10% reduction in leakage)
  • 20.4 gram mean reduction in pad weight (urine loss) yielding 56% to 106% better outcomes and requiring at 5x less treatment time than competitive products using electrical stimulation, based on published studies
Randomized Double Blind Multi Center Study Chart

Papers and Presentations 

 

ICS 2020 Abstract #26: Novel Pelvic Floor Treatment with Mechanotherapy: Final Clinical Trial Results in Women with Stress Urinary Incontinence (SUI). Nakib N, Sutherland S, Hallman K. 

Acta Obstetrica et Gynecologica Scandinavica Volume 97, Issue 10: 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; Ingard Nilsen, Guillermo Rebolledo, Ganesh Acharya, Gunnar Leivseth

Female Pelvic Medicine & Reconstructive Surgery: September/October 2019 - Volume 25 - Issue 5S - p S26–S79
doi: 10.1097/SPV.0000000000000763

Female Pelvic Medicine & Reconstructive Surgery: September/October 2019 - Volume 25 - Issue 5S - p S80–S166
doi: 10.1097/SPV.0000000000000767

Questions about how Flyte can fit into your practice?

Schedule a conversation to learn more about Flyte, our clinical results and partnering with Pelvital.

1-866-PELVITAL

8:00 AM - 5:00 PM CDT

[email protected]