Flyte System Transvaginal Mechanotherapy for Urinary Incontinence in Endometrial and Cervical Cancer Survivors: A Pilot Study
Mayo Clinic
Summary
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.
Eligibility
- Age range
- 21+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Female patients who have received conventionally fractioned adjuvant or primary pelvic radiation therapy for endometrial or cervical cancer ≥ 3 months prior to registration * Age ≥ 21 years at enrollment * English speaking * Demonstrates understanding of the study protocol and has signed the Informed Consent Form (ICF) * Has a clinical diagnosis of urinary incontinence (stress urinary incontinence \[SUI\], urge urinary incontinence \[UUI\], mixed) or overactive bladder (OAB) * Ability to contract the pelvic floor muscles (PFMs) without pain * Ability to tolerate size 6 v…
Interventions
- OtherEducational Intervention
Given educational handouts
- OtherInterview
Patients are interviewed on study
- DeviceFlyte Medical Device Usage and Evaluation
Use Flyte device
- OtherQuestionnaire Administration
Participants complete questionnaires on study
- OtherReferral
Given referral for in-person pelvic floor physical therapy
Location
- Mayo Clinic in RochesterRochester, Minnesota