Stress Urinary Incontinence
Millions of women suffer from unexpected bladder leaks during normal physical activities – a condition known as stress urinary incontinence (SUI). These leaks happen during normal physical activities that put pressure on the bladder, such as laughing, coughing, sneezing or exercising. SUI affects women of all ages and can greatly affect quality of life. It is often caused by physical changes from pregnancy, childbirth, and menopause.
Pelvic floor muscle training, also known as Kegel exercises, can be effective in strengthening pelvic floor muscles to reduce or eliminate leakage. However, these muscles can be difficult to isolate, with some women contracting the wrong muscles during these exercises. In addition, Kegel exercises, even when done properly, do not always cure SUI. Although surgery for SUI maybe recommended, and often has a high rate of success, surgery is not free from complications. Due to the moderate success of Kegel exercises, and potential side effects from surgery, there is a need for new SUI treatments.
The FlyteTM System was developed by physicians who are experts in gynecology, muscle rehabilitation and urinary incontinence treatments. It uses a unique therapy called “mechanotherapy” which is designed to strengthen and potentially heal the pelvic floor muscle system. Mechanotherapy is a proven method for strengthening and healing muscle systems, but has not been used to treat pelvic floor muscles until now. 1,2,3,4
The Flyte System is an investigational device and is used intravaginally during pelvic floor muscle training exercises, also known as Kegel exercises. Mechanotherapy is delivered with each pelvic floor contraction, amplifying the benefit of one contraction approximately 39 times. The Flyte System also provides visual guidance on how to conduct a proper Kegel contraction. It is used at home for 5 minutes a day during the six-week treatment period.
Early Pelvital clinical results in women with stress urinary incontinence demonstrated a high cure rate.5 Patients also reported the device was comfortable and easy to use.
- Engber DE. Cellular mechanotransduction: putting all pieces together again. FASEB J 2006; 20: 811-827.
- Iskratsch T, Wolfenson H, Sheetz MP. Appreciating force and shape – the rise of mechanotransduction in cell biology. Molecular Cell Biology 2014; 15: 825-833.
- Paulch EP, Nelson CM, Biais N, Fabry B, Moeller J, Pruitt BL et al. Mechanotransduction: use the force(s). BMC Biology 2015: 13-47.
- Salanova M, Gelfi C, Moriggi M, Vasso M, Viganò A. et al. Disuse deterioration of human skeletal muscle challenged by resistive exercise superimposed with vibration: evidence from structural and proteomic analysis. FASEB J 2014 Nov; 28(11):4748-63.
- Nilsen I, Rebolledo G, Acharya G, Leivseth G. 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. Acta Obstet Gynecol Scand. 2018;00:1-7. https://doi.org/10.1111/aogs.13412
Pelvital Clinical Study
Update: Enrollment is now closed. Doctors at select US centers are accepting participants for a new clinical study to evaluate the FlyteTM System for the treatment of stress urinary incontinence (SUI). Participants who qualify and choose to participate in the study will receive the Flyte System and all study-related costs will be covered at no charge to them. Learn more.
Initial study eligibility criteria include the following:
- Stress urinary incontinence diagnosis
- 18-75 years old
- Not currently pregnant
- Not currently taking prescription medications for SUI
- Able to attend up to 8 clinic visits over 3 months
The FlyteTM System is an investigational device being evaluated in US clinical study for stress urinary incontinence (SUI). Flyte is a conservative, in-home treatment that is used intravaginally during pelvic floor muscle training exercises, also known as Kegel exercise, for five minutes per day. It is a cost-effective solution designed to strengthen and potentially heal the pelvic floor muscle for women who suffer from stress urinary or mixed incontinence.
Flyte was designed by gynecologists and experts in muscle rehabilitation and urinary incontinence treatments. It is the first and only SUI treatment to use mechanotherapy, a proven treatment for healing muscles.
CAUTION: The Flyte System is an investigational device. Limited by United States law to investigational use only.