Clinical Results

Flyte® is backed by strong clinical evidence - more than most conservative therapy devices

Flyte® was studied in patients with stress urinary incontinence (SUI) in two key studies including a 60 patient study in Norway and a 119 patient study in the U.S., one of the largest of its kind for an in-home treatment. Both studies used pad weight - a very objective measure - as the primary outcome measure. Both studies also looked at quality of life and long-term durability (whether the treatment lasts even after you stop using Flyte).

In both studies, Flyte® demonstrated continence rates and durability comparable to surgery in only 5 minutes per day for six to twelve weeks.

Whether you have occasional "nuisance" leaks, or if your SUI is more severe and you're considering surgery, Flyte® is the clinically proven treatment option.

Single-Center Study at Arctic University of Norway (60 patients)

  • Patients had on average over 9 years of symptoms and had been recommended for surgery prior to the study.
  • 82% of patients were continent at 6 weeks.
  • 77% of patients reported continence at 2-year follow-up (36 patients responded).
  • All patients who tried Flyte were able to avoid surgery at the 2-year follow-up.

Multi-Center, Randomized, Double-Blind, Controlled Study in United States (119 patients)

  • Included women with the highest level of severity SUI.
  • 71% of patients reported dry or near-dry results by 12 weeks — 37% of patients reported dry or near-dry results in as little as 2 weeks.
  • Over 90% of women said Flyte® is simple and easy to use (106 women surveyed).
  • Flyte® demonstrated effectiveness for mild, moderate, and severe stress urinary incontinence (SUI).
  • 2-year follow-up showed continued improvement in quality of life (34 patients answered survey at 2 years).

Flyte® is proven to improve the quality of life for women with SUI

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)

Flyte® is proven to reduce bladder leaks - both frequency and volume.

Norway Study

The Norwegian study included patients of mild and moderate stress urinary incontinence severity. The strong results are impressive and durable, with 82% of women continent in only 6 weeks, and 77% of women who responded to a 2-year follow-up question reporting continued continence.

US Study

Before starting therapy with Flyte®, patients in our US clinical trial experienced bladder leaks daily – between 10 – 500 grams a day. Twelve weeks into trial, they saw a dramatic reduction in leaks, most leaking 0 – 10 grams. Many conservative therapies perform poorly for women who have severe incontinence. Flyte® performed well, with 37% of patients reporting dry or near-dry results in a little as 2 weeks, and 71% by 12 weeks.