Cervical CarcinomaNCT07662824
Flyte Device for Improving Urinary Incontinence Among Endometrial and Cervical Cancer Survivors Who Have Undergone Radiation Therapy
A study testing Educational Intervention, Interview and Flyte Medical Device Usage and Evaluation in people with Cervical Carcinoma and Endometrial Carcinoma, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Cervical Carcinoma, Endometrial Carcinoma, Overactive Bladder
- What is being tested?
- Educational Intervention, Interview and Flyte Medical Device Usage and Evaluation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2026to 20 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kelly Gunderson contact
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Kelly Gunderson, 507-422-1892
About this study
Official title: 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.
- Being tested
- Educational Intervention, Interview, Flyte Medical Device Usage and Evaluation, Questionnaire Administration, Referral
- Medical subject headings
- Uterine Cervical Neoplasms, Endometrial Neoplasms, Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Given educational handouts
InterviewOther
Patients are interviewed on study
Flyte Medical Device Usage and EvaluationDevice
Use Flyte device
Questionnaire AdministrationOther
Participants complete questionnaires on study
ReferralOther
Also called Referred
Given referral for in-person pelvic floor physical therapy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Educational Intervention; Other: Interview; Other: Questionnaire Administration; Other: Referral |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 24 weeks
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.
Measured: 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.
Measured: Up to 24 weeks
Secondary outcomes (9)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study start20 Aug 2026
- Primary completion20 Aug 2028 (estimated)
- Study completion20 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shariska Harrington, Mayo Clinic
- Investigators
- Shariska Harrington, MD, Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07662824
- Sponsor's protocol ID
- 25-011307
- Status last verified
- Aug 2026
- First submitted
- 16 Jun 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flyte System Transvaginal Mechanotherapy for Urinary Incontinence in Endometrial and Cervical Cancer Survivors: A Pilot Study
- ClinicalTrials.gov ID
- NCT07662824
- Acronym / sponsor ID
- 25-011307
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 20 Aug 2026 (actual)
- Primary completion
- 20 Aug 2028 (estimated)
- Study completion
- 20 Aug 2028 (estimated)
- First posted
- 23 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Flyte device) | Experimental | Other: Interview, Device: Flyte Medical Device Usage and Evaluation, Other: Questionnaire AdministrationPatients use the Flyte device over 5 minutes daily during Kegel exercises for 12 weeks in the absence of unacceptable toxicity. |
| Group 2 (referral, education) | Active comparator | Other: Educational Intervention, Other: Interview, Other: Questionnaire Administration, Other: ReferralPatients receive a referral for in-person pelvic floor physical therapy and educational handouts on Kegel exercises on study. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalGiven educational handouts | Other | Group 2 (referral, education) |
| InterviewPatients are interviewed on study | Other | Group 1 (Flyte device), Group 2 (referral, education) |
| Flyte Medical Device Usage and EvaluationUse Flyte device | Device | Group 1 (Flyte device) |
| Questionnaire AdministrationParticipants complete questionnaires on study | Other | Group 1 (Flyte device), Group 2 (referral, education) |
| ReferralAlso: ReferredGiven referral for in-person pelvic floor physical therapy | Other | Group 2 (referral, education) |
Primary outcome
Proportion of participants successfully completing study set up (Feasibility)
Time frame: Up to 24 weeks
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).
Incidence of all serious adverse events (SAEs) including unanticipated adverse device effects
Time frame: Up to 90 days the last administration of study treatment
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.
Incidence of all device failures and malfunctions
Time frame: Up to 24 weeks
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.
9 secondary outcomes
Quality of Life (QoL) - ICIQ-UI-SF
Time frame: Baseline up to 24 weeks
Quality of Life (QoL) - EPIC
Time frame: Baseline up to 24 weeks
Change in patient satisfaction with personal goal achievement
Time frame: Baseline up to 24 weeks
Change in pelvic floor muscle function
Time frame: Baseline up to 24 weeks
Adherence and usability of the Flyte system - frequency of use
Time frame: Up to 24 weeks
Adherence and usability of the Flyte system - session completion
Time frame: Up to 24 weeks
Change in perceived sexual function - FSFI
Time frame: Up to 24 weeks
Efficacy of Flyte therapy on other pelvic floor disorders
Time frame: Up to 24 weeks
Meaningful change in urinary incontinence
Time frame: Up to 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kelly Gunderson contact
Shariska Harrington, MD principal investigator
Mayo Clinic in Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Intervention, Interview and Flyte Medical Device Usage and Evaluation in people with Cervical Carcinoma and Endometrial Carcinoma, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants successfully completing study set up (Feasibility) (time frame: Up to 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.