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

NCT07662824 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 25-011307
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Incidence of all serious adverse events (SAEs) including unanticipated adverse device effects

  Will be summarized descriptively and reported as the number and proportion of participants experiencing at least one event. Events will be listed and summarized by severity, seriousness, and relationship to device use as assessed by the investigator.

  Up to 90 days the last administration of study treatment

• Incidence of all device failures and malfunctions

  Will be summarized descriptively and reported as the number and proportion of participants experiencing at least one event. Events will be listed and summarized by severity, seriousness, and relationship to device use as assessed by the investigator.

  Up to 24 weeks

• Proportion of participants successfully completing study set up (Feasibility)

  Feasibility will be considered acceptable if at least 65% of participants successfully complete study setup (receipt of the device, completion of onboarding, and download and activation of the mobile application).

  Up to 24 weeks

Secondary Outcomes (9)

• Quality of Life (QoL) - ICIQ-UI-SF

  Baseline up to 24 weeks

• Quality of Life (QoL) - EPIC

  Baseline up to 24 weeks

• Change in patient satisfaction with personal goal achievement

  Baseline up to 24 weeks

• Change in pelvic floor muscle function

  Baseline up to 24 weeks

• Adherence and usability of the Flyte system - frequency of use

  Up to 24 weeks

Study Arms (2)

Group 1 (Flyte device)

EXPERIMENTAL

Patients use the Flyte device over 5 minutes daily during Kegel exercises for 12 weeks in the absence of unacceptable toxicity.

Other: Interview; Device: Flyte Medical Device Usage and Evaluation; Other: Questionnaire Administration

Group 2 (referral, education)

ACTIVE COMPARATOR

Patients receive a referral for in-person pelvic floor physical therapy and educational handouts on Kegel exercises on study.

Other: Educational Intervention; Other: Interview; Other: Questionnaire Administration; Other: Referral

Interventions

Educational Intervention OTHER

Given educational handouts

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Group 2 (referral, education)

Interview OTHER

Patients are interviewed on study

Group 1 (Flyte device); Group 2 (referral, education)

Flyte Medical Device Usage and Evaluation DEVICE

Use Flyte device

Group 1 (Flyte device)

Questionnaire Administration OTHER

Participants complete questionnaires on study

Group 1 (Flyte device); Group 2 (referral, education)

Referral OTHER

Given referral for in-person pelvic floor physical therapy

Also known as: Referred

Group 2 (referral, education)

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Endometrial Neoplasms; Urinary Bladder, Overactive

Interventions

Early Intervention, Educational; Educational Status; Methods; Interviews as Topic; Physical Examination; Referral and Consultation

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Diagnostic Techniques and Procedures; Diagnosis; Professional Practice; Organization and Administration; Health Services Administration

Study Officials

• Shariska Harrington, MD

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Kelly Gunderson

CONTACT

507-422-1892

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: June 23, 2026
• Study Start (Estimated): August 13, 2026
• Primary Completion (Estimated): August 13, 2028
• Study Completion (Estimated): August 13, 2028
• Last Updated: June 23, 2026

Record last verified: 2026-06

Locations

US (1)