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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT07662824
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Educational Intervention — OTHER
    Given educational handouts
  • Interview — OTHER
    Patients are interviewed on study
  • Flyte Medical Device Usage and Evaluation — DEVICE
    Use Flyte device
  • Questionnaire Administration — OTHER
    Participants complete questionnaires on study
  • Referral — OTHER
    Given referral for in-person pelvic floor physical therapy

Study Details

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.

Key Dates

Start date
Aug 13, 2026
Status verified
Jun 2026
Primary completion
Aug 13, 2028
Completion
Aug 13, 2028

Study Design

Enrollment
44 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: Group 1 (Flyte device)
    Patients use the Flyte device over 5 minutes daily during Kegel exercises for 12 weeks in the absence of unacceptable toxicity.
  • Active Comparator: Group 2 (referral, education)
    Patients receive a referral for in-person pelvic floor physical therapy and educational handouts on Kegel exercises on study.

Primary Outcome Measure

Incidence of all serious adverse events (SAEs) including unanticipated adverse device effects [ Time Frame: Up to 90 days the last administration of study treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
Clinical Trials Referral Office
[email protected]
855-776-0015
Kelly Gunderson
507-422-1892
Shariska Harrington, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Rochester, MN

By condition
Cervical cancerEndometrial cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Mayo Clinic in Rochester· Rochester, MN

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