About this trial
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 criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Educational Intervention
- Interview
- Flyte Medical Device Usage and Evaluation
- Questionnaire Administration
- Referral