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.
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)
Participation in another clinical study which may interfere with study requirements
Currently receiving active cancer directed therapy (i.e., cytotoxic chemotherapy) in post hysterectomy patients
Completion of radiation therapy or surgery within 3 months of enrollment
Life expectancy is less than six months in the opinion of the investigator
Parallel
Educational Intervention
Other interventionGiven educational handouts
Interview
Other interventionPatients are interviewed on study
Flyte Medical Device Usage and Evaluation
DeviceUse Flyte device
Questionnaire Administration
Other interventionParticipants complete questionnaires on study
Referral
Other interventionGiven referral for in-person pelvic floor physical therapy
Proportion of participants successfully completing study set up (Feasibility)
Feasibility will be considered acceptable if at least 65% of participants successfully complete study setup (receipt of the device, completion of onboarding, and download and activation of the mobile application).
Incidence of all serious adverse events (SAEs) including unanticipated adverse device effects
Will be summarized descriptively and reported as the number and proportion of participants experiencing at least one event. Events will be listed and summarized by severity, seriousness, and relationship to device use as assessed by the investigator.
Incidence of all device failures and malfunctions
Will be summarized descriptively and reported as the number and proportion of participants experiencing at least one event. Events will be listed and summarized by severity, seriousness, and relationship to device use as assessed by the investigator.
Quality of Life (QoL) - ICIQ-UI-SF
Assessed using the International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI-SF), a questionnaire for evaluating the frequency, severity and impact on quality of life (QoL). The ICIQ-UI-SF consists of 4 questions related to urine leakage over the past 4 weeks. A score of 0 indicates no leakage and no impact on daily quality of life. Higher scores denote greater symptom severity and a more profound impact on daily functioning. Participants will be categorized into two strata based on their baseline ICIQ-UI-SF score: ≤12 (mild to moderate severity) and ≥13 (severe severity).
Quality of Life (QoL) - EPIC
Assessed using the Expanded Prostate Cancer Index Composite (EPIC) urinary and bowel domains, a questionnaire designed to measure QoL in patients with cancer. The questionnaire consists of 26 questions answered on various scales (e.g., a scale of 0-4 where 0=no problem and 4=big problem). Higher scores indicate better quality of life.
Change in patient satisfaction with personal goal achievement
Will be assessed using progress toward personal goals data collected within the Flyte app. Goal attainment measures will be summarized descriptively, including the proportion of participants reporting improvement or achievement of personal goals over time.
Change in pelvic floor muscle function
Will be assessed using device-generated metrics, including change in maximum average contraction and change in the range between maximum average contraction and maximum average relaxation. These measures will be summarized descriptively.
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