Flyte Device for Urinary Incontinence in Cancer Survivors
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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants use the Flyte device over 5 minutes daily during Kegel exercises for 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Extension
Participants may continue to use the Flyte device for ongoing management of urinary incontinence
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
Patients use the Flyte device over 5 minutes daily during Kegel exercises for 12 weeks in the absence of unacceptable toxicity.
Patients receive a referral for in-person pelvic floor physical therapy and educational handouts on Kegel exercises on study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
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
4.
urologytimes.com
urologytimes.com/view/mechanotherapy-device-shows-efficacy-for-stress-urinary-incontinenceMechanotherapy 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
6.
digital-assets.wellmark.com
digital-assets.wellmark.com/adobe/assets/urn:aaid:aem:9918de22-cf28-49ec-bf4e-c51b02af546d/original/as/Miscellaneous-Investigational-Therapies-and-Tests-for-Urinary-Incontinence.pdfMiscellaneous-Investigational-Therapies-and-Tests-for- ...
FlyteTM System received FDA clearance through 510k process (K212655). the strengthening of the pelvic floor muscles,
7.
clinicaltrialsarena.com
clinicaltrialsarena.com/news/pelvitals-flyte-device-proves-effective-in-published-urinary-continence-study/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.
8.
flytesystem.com
flytesystem.com/pages/about-pelvital?srsltid\u003dAfmBOoq8ivnS0PHfKkTHeg4TlcbXBoDkjSSZ2HMen9ij5AJcoJ36wI6YAbout 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 ...
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