Recruiting

Flyte

Sponsor:

Mayo Clinic

Code:

NCT07662824

Conditions

Cervical Carcinoma

Endometrial Carcinoma

Overactive Bladder

Voiding Disorders

Eligibility Criteria

Sex: Female

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Educational Intervention

Interview

Flyte Medical Device Usage and Evaluation

Questionnaire Administration

Referral

Study Details

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.

Conditions

Cervical Carcinoma

Endometrial Carcinoma

Overactive Bladder

Voiding Disorders

Study ID

NCT07662824

Start date

Aug 20, 2026

Status verified date

Aug, 2026

Completion date

Aug 20, 2028

Anticipated

Primary completion date

Aug 20, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 21+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

44 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Device Feasibility

Interventions and Outcome Measures

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.

Interventions

Educational Intervention

Given educational handouts

Interview

Patients are interviewed on study

Flyte Medical Device Usage and Evaluation

Use Flyte device

Questionnaire Administration

Participants complete questionnaires on study

Referral

Given referral for in-person pelvic floor physical therapy

Primary outcome measure

  • Proportion of participants successfully completing study set up (Feasibility) [ Time Frame: Up to 24 weeks ]
  • Incidence of all serious adverse events (SAEs) including unanticipated adverse device effects [ Time Frame: Up to 90 days the last administration of study treatment ]
  • Incidence of all device failures and malfunctions [ Time Frame: Up to 24 weeks ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Kelly Gunderson

507-422-1892

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Kelly Gunderson

507-422-1892

Principal Investigator:

Shariska Harrington, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Aug 31, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-08-31.