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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Overactive Bladder; Voiding Disorders; Cervical Carcinoma; Endometrial Carcinoma
• Intervention / Treatment: Other: Interview; Device: Flyte Medical Device Usage and Evaluation; Other: Questionnaire Administration; Other: Educational Intervention; Other: Referral

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
• Study Contact Backup: Name: Kelly Gunderson; Phone Number: 507-422-1892

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester
      • Contact: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
      • Contact: Kelly Gunderson; Phone Number: 507-422-1892
      • Principal Investigator: Shariska Harrington, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Interview; Patients are interviewed on study; Device: Flyte Medical Device Usage and Evaluation; Use Flyte device; Other: Questionnaire Administration; Participants complete questionnaires on study
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.	Other: Interview; Patients are interviewed on study; Other: Questionnaire Administration; Participants complete questionnaires on study; Other: Educational Intervention; Given educational handouts; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Other: Referral; Given referral for in-person pelvic floor physical therapy; Other Names: Referred

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life (QoL) - ICIQ-UI-SF	Assessed using the International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI-SF), a questionnaire for evaluating the frequency, severity and impact on quality of life (QoL). The ICIQ-UI-SF consists of 4 questions related to urine leakage over the past 4 weeks. A score of 0 indicates no leakage and no impact on daily quality of life. Higher scores denote greater symptom severity and a more profound impact on daily functioning. Participants will be categorized into two strata based on their baseline ICIQ-UI-SF score: ≤12 (mild to moderate severity) and ≥13 (severe severity).	Baseline up to 24 weeks
Quality of Life (QoL) - EPIC	Assessed using the Expanded Prostate Cancer Index Composite (EPIC) urinary and bowel domains, a questionnaire designed to measure QoL in patients with cancer. The questionnaire consists of 26 questions answered on various scales (e.g., a scale of 0-4 where 0=no problem and 4=big problem). Higher scores indicate better quality of life.	Baseline up to 24 weeks
Change in patient satisfaction with personal goal achievement	Will be assessed using progress toward personal goals data collected within the Flyte app. Goal attainment measures will be summarized descriptively, including the proportion of participants reporting improvement or achievement of personal goals over time.	Baseline up to 24 weeks
Change in pelvic floor muscle function	Will be assessed using device-generated metrics, including change in maximum average contraction and change in the range between maximum average contraction and maximum average relaxation. These measures will be summarized descriptively.	Baseline up to 24 weeks
Adherence and usability of the Flyte system - frequency of use	Will be assessed using app-derived usage data (e.g., how many times they accessed the app) and summarized descriptively.	Up to 24 weeks
Adherence and usability of the Flyte system - session completion	Will be assessed using app-derived usage data (e.g., session completion) and summarized descriptively.	Up to 24 weeks
Change in perceived sexual function - FSFI	Assessed using the Female Sexual Function Index (FSFI), a questionnaire used to assess female sexual feelings and responses during the past 4 weeks. The FSFI consists of 19 questions answered using various scales such as 0-5 where 0=no sexual activity, 1=very low or none at all, 2=low, 3-moderate, 4=high, and 5=very high. Scores range from 2-36 with higher scores indicating greater levels of sexual functioning.	Up to 24 weeks
Efficacy of Flyte therapy on other pelvic floor disorders	Assessed using the gynecologic subset of the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE-GYN). The PRO-CTCAE was developed to assess patient self-reported symptoms in cancer clinical trials. The questionnaire consists of 27 questions related to symptoms and side effects experienced over the past 7 days. Each question is answered on a 5-point scale (e.g., none, mild, moderate, severe, very severe or never, rarely occasionally, frequently, almost constantly). The final question is a yes/no question about any other symptoms with opportunity to list any not included in the assessment. Higher scores indicate that patients are experiencing worse or more frequent/severe symptoms and side effects.	Up to 24 weeks
Meaningful change in urinary incontinence	Assessed using the narrative description and personalized meaningful change description sections of the Anchored Episodic Recall (AER) exercise, a psychological and cognitive intervention technique adapted for use to retrain bladder signaling. Results will be analyzed descriptively.	Up to 24 weeks

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Shariska Harrington, MD, Mayo Clinic in Rochester

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Estimated): August 13, 2026
• Primary Completion (Estimated): August 13, 2028
• Study Completion (Estimated): August 13, 2028

Study Registration Dates

• First Submitted: June 16, 2026
• First Submitted That Met QC Criteria: June 22, 2026
• First Posted (Actual): June 23, 2026

Study Record Updates

• Last Update Posted (Actual): June 23, 2026
• Last Update Submitted That Met QC Criteria: June 22, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Lower Urinary Tract Symptoms; Urological Manifestations; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Neoplasms; Urinary Bladder Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Uterine Cervical Neoplasms; Endometrial Neoplasms; Urinary Bladder, Overactive; Professional Practice; Organization and Administration; Health Services Administration; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Diagnostic Techniques and Procedures; Diagnosis; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Health Services; Health Care Facilities Workforce and Services; Child Health Services; Community Health Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Methods; Interviews as Topic; Early Intervention, Educational; Educational Status; Referral and Consultation; Physical Examination
• Other Study ID Numbers: 25-011307

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No