Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational Intervention | Other | Given educational handouts |
|
| 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 |
| 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). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Referral Office | Contact | 855-776-0015 | mayocliniccancerstudies@mayo.edu | |
| Kelly Gunderson | Contact | 507-422-1892 |
| Name | Affiliation | Role |
|---|---|---|
| Shariska Harrington, MD | Mayo Clinic in Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
Not provided
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
|
|
| 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 |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D016889 | Endometrial Neoplasms |
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| D004522 | Educational Status |
| D008722 | Methods |
| D007407 | Interviews as Topic |
| D010808 | Physical Examination |
| D012017 | Referral and Consultation |
| ID | Term |
|---|---|
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D008919 | Investigative Techniques |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
Not provided
Not provided