NCT07662824 · Mayo Clinic
Flyte Device for Improving Urinary Incontinence Among Endometrial and Cervical Cancer Survivors Who Have Undergone Radiation Therapy
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
Educational Intervention
Given educational handouts
OTHER
Interview
Patients are interviewed on study
DEVICE
Flyte Medical Device Usage and Evaluation
Use Flyte device
OTHER
Questionnaire Administration
Participants complete questionnaires on study
OTHER
Referral
Given referral for in-person pelvic floor physical therapy
Primary outcome measures
Proportion of participants successfully completing study set up (Feasibility)
Time frame: Up to 24 weeks
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
Time frame: Up to 90 days the last administration of study treatment
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
Time frame: Up to 24 weeks
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 vaginal dilator
- Internet access
- Access to an iOS or Android smartphone or tablet with capabilities to download and use the Flyte app
- Willing and able to participate in follow-up
Exclusion criteria
- 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
- Inability to tolerate insertion of the intravaginal wand. This will be recorded to support the usability of Flyte secondary endpoint
- Suspected vesicovaginal or colovaginal fistula
- Physical limitations that impede the patient's ability to participate (e.g., ability to grasp the wand and insert it and ability to turn on the Flyte controller unit)
- Acute infection or hematuria
- Inability to contract the PFMs or pain with contraction, as confirmed with intravaginal exam
- Impaired cognitive function or neurologic conditions
Where
- Rochester, Minnesota
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 31, 2026 · Source of record for eligibility and locations