NCT07662824 Flyte Device for Improving Urinary Incontinence Among Endometrial and Cervical Cancer Survivors Who Have Undergone Radiation Therapy
| NCT ID | NCT07662824 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mayo Clinic |
| Condition | Cervical Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 44 participants |
| Start Date | 2026-08-20 |
| Primary Completion | 2028-08-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 44 participants in total. It began in 2026-08-20 with a primary completion date of 2028-08-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Shariska Harrington, MD
PRINCIPAL INVESTIGATOR
Mayo Clinic in Rochester
Frequently Asked Questions
Who can join the NCT07662824 clinical trial?
This trial is open to female participants only, aged 21 Years or older, studying Cervical Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07662824 currently recruiting?
Yes, NCT07662824 is actively recruiting participants. Contact the research team at mayocliniccancerstudies@mayo.edu for enrollment information.
Where is the NCT07662824 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT07662824 clinical trial?
NCT07662824 is sponsored by Mayo Clinic. The principal investigator is Shariska Harrington, MD at Mayo Clinic in Rochester. The trial plans to enroll 44 participants.