44 Participants NeededMy employer runs this trial

Flyte Device for Urinary Incontinence in Cancer Survivors

CT
KG
Overseen ByKelly Gunderson
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the Flyte device, designed to help endometrial and cervical cancer survivors improve bladder control at home. Many individuals experience urinary incontinence after radiation therapy, which can disrupt daily life. The Flyte device uses vibrations during Kegel exercises to strengthen pelvic muscles and may improve symptoms. Those who underwent radiation therapy for these cancers at least three months ago and struggle with bladder control might be suitable for this trial. Participants will either use the Flyte device or receive traditional pelvic floor therapy and education on Kegel exercises. As an unphased trial, this study offers participants the chance to explore innovative solutions for enhancing their quality of life.

What prior data suggests that the Flyte device is safe for cancer survivors?

Research has shown that the Flyte device is generally safe to use. The FDA has cleared it, confirming it meets specific safety standards. One study found that 71% of participants controlled their bladder within two to 12 weeks of using the Flyte device. Participants reported no major safety issues, indicating the device is well-tolerated. The device uses gentle vibrations to strengthen pelvic muscles, improving bladder control without causing significant side effects.12345

Why are researchers excited about this trial?

Most treatments for urinary incontinence in cancer survivors often involve pelvic floor exercises or physical therapy. However, the Flyte Device is unique because it offers a new, convenient delivery method by incorporating a daily 5-minute session during Kegel exercises. Researchers are excited about this approach because it simplifies the treatment process and can be done at home, potentially increasing adherence and effectiveness. Unlike traditional methods that require in-person therapy sessions, the Flyte Device provides an innovative way to support pelvic floor strengthening, which could lead to improved outcomes for users.

What evidence suggests that the Flyte device is effective for urinary incontinence in cancer survivors?

Research has shown that the Flyte device, which participants in this trial may use, helps improve urinary incontinence. In studies, 71% of users became dry or almost dry within 6 to 12 weeks. It also reduced urine leakage over time. The Flyte device sends vibrations during Kegel exercises, strengthening the pelvic floor muscles. This method has improved symptoms and quality of life for endometrial and cervical cancer survivors who have undergone radiation therapy.15678

Who Is on the Research Team?

SH

Shariska Harrington, MD

Principal Investigator

Mayo Clinic in Rochester

Are You a Good Fit for This Trial?

This trial is for people who have survived endometrial or cervical cancer and had radiation therapy, and now have problems with bladder control (urinary incontinence).

Inclusion Criteria

I have been diagnosed with urinary incontinence or overactive bladder.
I understand the study and have signed the consent form.
English speaking
See 7 more

Exclusion Criteria

I do not have physical limitations that prevent me from using the device as required.
Impaired cognitive function or neurologic conditions
I may have an abnormal connection between my bladder or colon and vagina.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the Flyte device over 5 minutes daily during Kegel exercises for 12 weeks

12 weeks
In-home use

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Extension

Participants may continue to use the Flyte device for ongoing management of urinary incontinence

Long-term

What Are the Treatments Tested in This Trial?

Interventions

  • Flyte Device

Trial Overview

The study tests the Flyte device, which uses gentle vibrations during pelvic floor exercises at home to help improve bladder control. Participants also receive education, interviews, questionnaires, and referrals as part of the study.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Group 1 (Flyte device)Experimental Treatment3 Interventions
Group II: Group 2 (referral, education)Active Control4 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

Citations

Flyte Device for Improving Urinary Incontinence Among ...

The Flyte device may improve urinary incontinence symptoms, as well as overall quality of life among endometrial and cervical cancer survivors

Randomized trial of mechanotherapy for the treatment ... - PMC

The volume of urine loss was very significantly reduced at 6-weeks, with further reduction from 6-12 weeks. Data were then divided into subgroups

Flyte Device for Improving Urinary Incontinence among ...

The Flyte device may improve urinary incontinence symptoms, as well as overall quality of life among endometrial and cervical cancer survivors

Mechanotherapy device shows efficacy for stress urinary ...

"Our outcomes showed 71% of patients achieved dry or near dry results in 6 to 12 weeks," says Nissrine Nakib, MD.

68 Urinary Incontinence Trials Near You

The Flyte device may improve urinary incontinence symptoms, as well as overall quality of life among endometrial and cervical cancer survivors

Miscellaneous-Investigational-Therapies-and-Tests-for- ...

FlyteTM System received FDA clearance through 510k process (K212655). the strengthening of the pelvic floor muscles,

Pelvital's Flyte device proves effective in published urinary ...

In the study investigating Pelvital's Flyte device, 71% of participants achieved continence in two to 12 weeks.

About Pelvital - Flyte System

The paper presents evidence of the efficacy of Pelvital's novel, FDA-cleared device, Flyte, for the treatment of stress urinary incontinence (SUI) and weakened ...