NCT07662824Recruiting
Flyte Device for Improving Urinary Incontinence Among Endometrial and Cervical Cancer Survivors Who Have Undergone Radiation Therapy
Flyte System Transvaginal Mechanotherapy for Urinary Incontinence in Endometrial and Cervical Cancer Survivors: A Pilot Study
Source: ClinicalTrials.gov · Last updated 31 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 44 (estimated)
- First submitted
- 16 Jun 2026
- Start date
- 20 Aug 2026
- Primary completion date
- 20 Aug 2028
- Lead sponsor
- Mayo Clinic
- Diseases
- Endometrial cancer, Cervical cancer
- NCT number
- NCT07662824
What you commit to
- Study type: Interventional
- Planned participants: 44
- From 20 Aug 2026 to the primary completion date, 20 Aug 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Suspected vesicovaginal or colovaginal fistula
- Acute infection or hematuria
- Impaired cognitive function or neurologic conditions
Other
- Participation in another clinical study which may interfere with study requirements
- 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
- 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)
- Inability to contract the PFMs or pain with contraction, as confirmed with intravaginal exam
Who the study is looking for
- 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
Age in the registry: 21 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mayo Clinic in Rochester Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.