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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age21+
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Educational Intervention
  • Interview
  • Flyte Medical Device Usage and Evaluation
  • Questionnaire Administration
  • Referral

Treatment groups

44 Participants
are divided into 2 treatment groups

Sponsors and collaborators