Flyte device to help urinary incontinence after pelvic radiation for endometrial or cervical cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study evaluates the Flyte medical device as a home-based mechanotherapy aid for urinary incontinence in endometrial and cervical cancer survivors who completed pelvic radiation. Participants perform guided pelvic floor contractions while the device delivers targeted mechanical vibrations during the exercises. The study also includes educational components, interviews, questionnaires, and follow-up to assess usability, tolerability, and impact on quality of life. Eligible participants are adult women with a history of pelvic radiation and a diagnosis of stress or urge incontinence, who can use a smartphone/tablet and access the Flyte app. The trial is conducted at Mayo Clinic in Rochester, with data collected to determine feasibility and potential benefits of in-home Flyte use.

Why it matters

Who can join: the full rules

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 it's running

• Mayo Clinic in Rochester
  Rochester, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Shariska Harrington, MD — Mayo Clinic in Rochester
• Study coordinator: Clinical Trials Referral Office
• Email: mayocliniccancerstudies@mayo.edu
• Phone: 855-776-0015

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.