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

NCT07662824 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2026-06-23

No results posted yet for this study

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

Interventions

OTHER

Educational Intervention

Given educational handouts

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

OTHER

Referral

Given referral for in-person pelvic floor physical therapy

Sponsors & Collaborators

Principal Investigators

  • Shariska Harrington, MD · Mayo Clinic in Rochester

Study Design

Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-13
Primary Completion
2028-08-13
Completion
2028-08-13
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07662824 on ClinicalTrials.gov