Cervical Carcinoma, Endometrial Carcinoma, Overactive Bladder, Voiding Disorders
Conditions
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.
Interventions
OTHEREducational Intervention
Given educational handouts
OTHERInterview
Patients are interviewed on study
DEVICEFlyte Medical Device Usage and Evaluation
Use Flyte device
OTHERQuestionnaire Administration
Participants complete questionnaires on study
OTHERReferral
Given referral for in-person pelvic floor physical therapy
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of all serious adverse events (SAEs) including unanticipated adverse device effects | 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 | 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. |
| Proportion of participants successfully completing study set up (Feasibility) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life (QoL) - ICIQ-UI-SF | Baseline up to 24 weeks | 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). |
| Quality of Life (QoL) - EPIC | Baseline up to 24 weeks | 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. |
| Change in patient satisfaction with personal goal achievement | Baseline up to 24 weeks | 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. |
| Change in pelvic floor muscle function | Baseline up to 24 weeks | 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. |
| Adherence and usability of the Flyte system - frequency of use | Up to 24 weeks | Will be assessed using app-derived usage data (e.g., how many times they accessed the app) and summarized descriptively. |
| Adherence and usability of the Flyte system - session completion | Up to 24 weeks | Will be assessed using app-derived usage data (e.g., session completion) and summarized descriptively. |
| Change in perceived sexual function - FSFI | Up to 24 weeks | 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. |
| Efficacy of Flyte therapy on other pelvic floor disorders | Up to 24 weeks | 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. |
| Meaningful change in urinary incontinence | Up to 24 weeks | 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. |
Countries
United States
Contacts
CONTACTClinical Trials Referral Office
CONTACTKelly Gunderson
PRINCIPAL_INVESTIGATORShariska Harrington, MD
Mayo Clinic in Rochester
Outcome results
None listed