This clinical trial studies how well and how easy it is to use a device called Flyte in improving problems with bladder control (urinary incontinence) among endometrial and cervical cancer survivors who have undergone radiation therapy. Urinary incontinence is common after pelvic radiation therapy and can affect daily life and well-being. Access to in-person pelvic floor physical therapy can be limited. The Flyte device is designed for in-home use to deliver a series of mechanical vibrations at a specific frequency while the pelvic floor muscles are contracting and relaxing (i.e., normal, guided Kegel exercises). This treatment is called mechanotherapy. The Flyte device may improve urinary incontinence symptoms, as well as overall quality of life among endometrial and cervical cancer survivors who have undergone radiation therapy.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07662824.
Locations matching your search criteria
United States
Minnesota
Rochester
Mayo Clinic in RochesterStatus: Active
Contact: Shariska Harrington
Phone: 507-538-5867
PRIMARY OBJECTIVES:
I. Determine the feasibility of using Flyte, a home-based device that uses transvaginal mechanotherapy to strengthen the pelvic floor and facilitate neuromuscular memory to improve urinary incontinence, after radiation therapy in patients with cervical and endometrial cancer.
II. Demonstrate the safety of Flyte by evaluating (a) the incidence of all serious adverse events (AEs) including unanticipated adverse device effects and (b) the incidence of all device failures and malfunctions.
SECONDARY OBJECTIVES:
I. Evaluate the impact of Flyte, a home-based device that uses transvaginal mechanotherapy to strengthen the pelvic floor and facilitate neuromuscular memory, on quality of life (QOL) measures related to urinary incontinence during the immediate survivorship period among patients with cervical and endometrial cancer.
II. Evaluate patient satisfaction with Flyte therapy, as assessed by progress towards personal goals captured through the Flyte mobile application.
III. Evaluate changes in pelvic floor muscle performance, including improvement in maximum average contraction and range between maximum average contraction and maximum average relaxation, as measured by device-generated data collected through the Flyte application.
IV. Assess patient adherence to Flyte therapy, including barriers related to compliance and usability of the device and/or application, using device-derived and patient-reported data.
V. Explore the impact of Flyte therapy on other pelvic floor disorders, including fecal incontinence and sexual dysfunction.
VI. Explore meaningful change in urinary incontinence from patient perspectives through the Anchored Episodic Recall (AER) exercise using the narrative description and personalized meaningful change description.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP 1: Patients use the Flyte device over 5 minutes daily during Kegel exercises for 12 weeks in the absence of unacceptable toxicity.
GROUP 2: Patients receive a referral for in-person pelvic floor physical therapy and educational handouts on Kegel exercises on study.
After completion of study intervention, patients are followed up at 24 weeks.
Trial PhaseNo phase specified
Trial Typedevice
Lead OrganizationMayo Clinic in Rochester
Principal InvestigatorShariska Harrington
