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Flyte Device for Bladder Control After Cancer Radiation

This study is looking at how well and how easy it is for endometrial and cervical cancer survivors to use a device called Flyte to improve bladder control problems (urinary incontinence) after radiation therapy. Urinary incontinence can be a common issue after pelvic radiation. The Flyte device is used at home and delivers gentle vibrations while you do pelvic floor exercises (like Kegels). The study will enroll 44 women who are at least 21 years old, speak English, and have been diagnosed with urinary incontinence after radiation for endometrial or cervical cancer. Researchers will look at how many serious side effects occur, if the device works properly, and how many participants successfully start using the device. The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 44 women. It is not specified if it is randomized or blinded.
What's involved
You would use the Flyte device, complete questionnaires, and be interviewed. You would also receive educational handouts and a referral for pelvic floor physical therapy.
Compensation
Not stated in the trial record.
Follow-up
Researchers will track serious side effects for up to 90 days after the last study treatment. Device failures and successful setup will be monitored for up to 24 weeks.

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NCT07662824

Flyte Device for Improving Urinary Incontinence Among Endometrial and Cervical Cancer Survivors Who Have Undergone Radiation Therapy

Not Yet Recruiting
NAAges 21+InterventionalDevice feasibility
Mayo Clinic
~44 participants
Updated 2026-06-23 on ClinicalTrials.gov
What's tested:Educational InterventionInterviewFlyte Medical Device Usage and EvaluationQuestionnaire AdministrationReferral

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of all serious adverse events (SAEs) including unanticipated adverse device effects
Measured over Up to 90 days the last administration of study treatment
+2 more outcomes measured

Conditions

Cervical Carcinoma
Endometrial Carcinoma
Overactive Bladder
Voiding Disorders

Explore related trials

Cervical CarcinomaEndometrial CarcinomaOveractive BladderVoiding Disorders

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Shariska Harrington, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic in Rochester

Who to contact

Clinical Trials Referral Office
[email protected]
855-776-0015
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Incidence of all serious adverse events (SAEs) including unanticipated adverse device effectsUp 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 malfunctionsUp 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.

  • Proportion of participants successfully completing study set up (Feasibility)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).