Clinical Results
Flyte is backed by strong clinical evidence
Flyte was studied in patients with stress urinary incontinence (SUI) in two key studies including a 119 patient, multi-center double blind, randomized trial, one of the largest of its kind for an in-home SUI treatment.
Single-Center Study at Arctic University of Norway
Pelvic floor training 5 mins/day for 4-6 weeks using Flyte™ (n=60 female SUI patients; mean age=47; all referred for surgery)
- 1-hour standard volume stress tests to measure urine lost and captured in incontinence pads
- After 6 weeks, 82.9% of patients were continent (defined as ≤4g leakage)
- Urine leakage decreased from a mean of 20.3g +/- 12.2g to 1.5g +/- 6.7g
- Patients (n=36) followed for 2 years; 77% reported continued continence at the 2-year mark; none underwent surgery
120-Patient SUI Multi-Center, Randomized, Double-Blind, Controlled Study in United States
- Final enrollment: n=119 patients. 5 mins/day treatment sessions for 12 weeks; Control group crossed over to treatment at week 6
- 24-hour pad weight tests to measure urine lost and captured in incontinence pads
- Within 2 -12 weeks, 71% of patients were dry or near dry (defined as < 10 g leakage in 24 hours)
- At 6 weeks, 81% of patients were responders. At 12 weeks, 91% of patients were responders (defined as ≥ 10% reduction in leakage)
- 21.4 grams mean reduction in pad weight, yielding 57% to 300% better outcomes and requiring at least 83% less treatment time than competitive products using electrical stimulation, based on published studies
Flyte is proven to reduce bladder leaks - both frequency and volume.
Before starting therapy with Flyte, patients in our US clinical trial experienced bladder leaks daily – between 10 – 500 grams a day. Twelve weeks into clinical trial, patients saw a dramatic reduction in leaks, most leaking 0 – 10 grams.
Flyte is proven to improve the quality of life for women with stress urinary incontinence.
90%
of users said Flyte is simple and easy to use (106 women surveyed)
87%
of users said Flyte was useful (106 women surveyed)
83%
of users would recommend Flyte to others (106 women surveyed)
Stop coping. Start treating at home.
(and say goodbye to all those pads!)