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

Korábbi kezelés

• 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

Más betegség

• Suspected vesicovaginal or colovaginal fistula
• Acute infection or hematuria
• Impaired cognitive function or neurologic conditions

Egyéb

• Participation in another clinical study which may interfere with study requirements
• 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
• 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)
• Inability to contract the PFMs or pain with contraction, as confirmed with intravaginal exam

• 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