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Not yet recruiting NCT07662824

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

No phase Interventional Cervical Carcinoma Endometrial Carcinoma Overactive Bladder Voiding Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Educational Intervention, Interview, Flyte Medical Device Usage and Evaluation, Questionnaire Administration.
Who it may be relevant to
Registry conditions: Cervical Carcinoma, Endometrial Carcinoma, Overactive Bladder, Voiding Disorders. Basic parameters: from 21 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Flyte System Transvaginal Mechanotherapy for Urinary Incontinence in Endometrial and Cervical Cancer Survivors: A Pilot Study

Overview

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

  • 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

Primary outcome measures

  • Incidence of all serious adverse events (SAEs) including unanticipated adverse device effects [Time frame: Up to 90 days the last administration of study treatment]
  • Incidence of all device failures and malfunctions [Time frame: Up to 24 weeks]
  • Proportion of participants successfully completing study set up (Feasibility) [Time frame: Up to 24 weeks]
Secondary outcome measures (9)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Device feasibility

Study locations

United States · 1 center
  • Mayo Clinic in Rochester — Rochester

Identifiers

NCT: NCT07662824 · 25-011307

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗