Clinical Results

Flyte® is backed by strong clinical evidence – demonstrating outcomes and durability of treatment comparable to surgery.

Clinical Studies

Flyte was studied in patients with stress urinary incontinence (SUI) in 2 peer-reviewed, published clinical studies, including one of the largest US studies of its kind for an in-home treatment.

The outcome measures were:

  • 1. Pad weight
  • 2. Quality of life
  • 3. Long-term durability of treatment effect

The Takeaway: Both studies showed that Flyte delivers continence rates and durability comparable to surgery in just 5 minutes a day for 6 to 12 weeks. Maintenance is not typically required.

A Deep Dive Into The Studies

Review Article

Published in Continence Reports in 2025,¹ an article reviewing the body of evidence surrounding transvaginal mechanotherapy for SUI demonstrated that transvaginal mechanotherapy for SUI delivers:

  • • Superior pad weight reduction compared to traditional pelvic floor muscle training (PFMT)

  • • Superior quality of life (QoL) improvements compared to traditional PFMT

  • • Continence and durability outcomes comparable to surgery


The Takeaway: Incorporating transvaginal mechanotherapy in the treatment of female SUI improves both objective and subjective outcomes, while avoiding the risks of surgery. Flyte is a first-line, accessible treatment that should be part of the standard of care for SUI when PFMT is indicated.



Read the article

A Closer Look at Flyte’s Clinical Studies

Single-Center Study at Arctic University (N = 60)²


Prior to the study, all participants had been referred to surgery after failing PFMT under supervised guidance for 1 year. The mean duration of symptoms was >9 years.

After completing Flyte protocol of 5 min per day for 6 weeks:

  • • 82% of participants were continent by 6 weeks

  • • 77% of participants reported continence at 2-year follow-up (N = 36)

  • • No participants went on to get surgery, even at 2-year follow-up


Flyte successfully helped these women avoid surgery for their stress urinary incontinence (SUI).

Read the study

Multi-Center, Randomized, Double-Blind, Controlled Study P-SUIT (N = 119)⁴

This study is unique in that it included women with mild, moderate, and severe stress urinary incontinence, including women with leakage of over 500g per 24 hours.

  • • 71% of participants were dry or near-dry in 2-12 weeks

  • • 91% of participants were responders to Flyte’s treatment


Long-term follow-up studied the durability of the treatment effect on quality of life over 2 years. Quality of life was measured via:

  • • International Consultation on Incontinence Questionnaire (ICIQ)

  • • Incontinence - Quality of Life Questionnaire (I-QOL): Despite majority discontinuing use of Flyte post-study, participants continued to improve, particularly for high-severity cases.

Read the study

How to Prescribe Flyte

To prescribe Flyte, simply:

  • 1. Complete the Flyte Prescription Form
  • 2. Fax with relevant clinical notes showing medical necessity to the number on the form.

Our DME partners will take it from there, including pre-authorization work if necessary.

If you are a physical or occupational therapist prescribing Flyte, you will need the Flyte Prescription Form to be signed by the referring provider.

Flyte Prescription Form