The Science: Clinical Evidence Behind Flyte
A growing body of scientific evidence confirms that Flyte™ 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
- Pilot study, Nilsen et. al. investigated whether mechanosignals during Kegel exercises could reduce the amount of urinary leakage in women with SUI after 4 and 6 weeks of training.
Material and methods:
- 60 women with stress urinary incontinence were included in this prospective cohort study
- All were recommended for surgery
- Mechanosignals were superimposed during Kegel exercises using an intravaginal device
- Each training session consisted of 15 maximal contractions of pelvic floor muscles for 5 seconds
- The women performed training (5 min/day) at home for 4 (n = 60) and 6 (n = 36) weeks
- Urine leakage (g) during stress test with standardized bladder volume, and contraction force without and with superimposed mechanical stimulations were measured at inclusion (T0), and after 4 (T2) and 6 (T3) weeks of training using an intravaginal device
- Incontinence Questionnaire—Short Form was recorded at T0, and in a sub-cohort of women (n = 36) at 2 years follow up.
- Mean urine leakage reduced significantly from 20.5 (± 12.2) g at T0 to 4.8 (± 6.7) g at T2 and 1.5 (± 3.5) g at T3
- After 4 and 6 weeks of training, urinary leakage was ≤ 4 g on stress tests in 44 and 49 of the 60 women, respectively
- At T0, the mean Incontinence Questionnaire—Short Form score was 13 (± 2.4), and at 2 years follow up, the score was 6.3 (± 3.75).
- Superimposed mechanical stimulation with Kegel exercises significantly reduced urinary leakage in women with stress urinary incontinence
- After 6 weeks, 82.9% of patients were continent (defined as ≤ 4g leakage)
Patients (n=36) followed for 2 years; 77% reported continued continence at the 2-year mark; none underwent surgery
Randomized, Double Blind, Controlled, Multi-Center Study
- The aim of this study was to evaluate if two-part mechanotherapy applied to pelvic floor muscles (PFM) in conjunction with PFMT improves continence in women with mild, moderate and severe SUI, and if one modality is better than the other.
- Treatment Arm: Part 1 & Part 2 mechanotherapy + PFMT
- Control Arm: Part 1 mechanotherapy only + PFMT
- Control arm subjects crossed over at 6 weeks
- Therapy for 5 min/day for 12 weeks
- 24-Hour Pad Test, Voiding Frequency and QoL at Baseline tested again at 6 & 12 weeks
- Long-term follow-up via telephone at 6, 12, 18 and 24 months
- Approximately 91% of patients responded by week 12 with almost 75% achieving a clinically meaningful reduction (>50%) in pad weight
- Roughly two-thirds of patients achieving continence (10 grams leakage (about 2 teaspoons) or less in a 24-hour pad weight test) as defined by the clinical investigators using the 24-hour pad test.
Although traditional PFMT works, Flyte acts as a great adjunct. It guides the patient to use the right muscles during treatment sessions and also saves time and improves compliance due to a shorter daily treatment time and number of weeks to use. Quality of life survey scores improved in participants over the course of the study.
- 90% said Flyte was simple and easy to use
- 87% said Flyte was useful
- 83% said they would recommend Flyte to others
Conclusion: Flyte™ Therapy with two-part mechanotherapy used as an adjunct with PFMT provided an effective, safe, non-invasive therapeutic option as assessed by multiple QoL instruments.
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
Female Pelvic Medicine & Reconstructive Surgery: September/October 2019 - Volume 25 - Issue 5S - p S80–S166