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

Официальное название

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

Обзор

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.

Вмешательства

• Другое Educational Intervention
  Given educational handouts
• Другое Interview
  Patients are interviewed on study
• Устройство Flyte Medical Device Usage and Evaluation
  Use Flyte device
• Другое Questionnaire Administration
  Participants complete questionnaires on study
• Другое Referral
  Given referral for in-person pelvic floor physical therapy

Первичные конечные точки

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

Вторичные конечные точки (9)

• Quality of Life (QoL) - ICIQ-UI-SF [Срок оценки: Baseline up to 24 weeks]
• Quality of Life (QoL) - EPIC [Срок оценки: Baseline up to 24 weeks]
• Change in patient satisfaction with personal goal achievement [Срок оценки: Baseline up to 24 weeks]
• Change in pelvic floor muscle function [Срок оценки: Baseline up to 24 weeks]
• Adherence and usability of the Flyte system - frequency of use [Срок оценки: Up to 24 weeks]
• Adherence and usability of the Flyte system - session completion [Срок оценки: Up to 24 weeks]
• Change in perceived sexual function - FSFI [Срок оценки: Up to 24 weeks]
• Efficacy of Flyte therapy on other pelvic floor disorders [Срок оценки: Up to 24 weeks]
• Meaningful change in urinary incontinence [Срок оценки: Up to 24 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Оценка устройства

Центры проведения

США · 1 центр

• Mayo Clinic in Rochester — Rochester

Идентификаторы

NCT: NCT07662824 · 25-011307

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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