Clinical Trials

Inclusion Criteria:

• Female patients who have received conventionally fractioned adjuvant or primary pelvic radiation therapy for endometrial or cervical cancer.

• Age ≥ 21 years at enrollment.

• Has a clinical diagnosis of urinary incontinence (SUI, UUI, Mixed) or Overactive Bladder (OAB).

• Demonstrates understanding of the study protocol and has signed the Informed Consent Form (ICF)

• Ability to contract the pelvic floor muscles (PFMs) without pain.

• Ability to tolerate size * vaginal dilator

• Internet access.

• Access to an iOS or Android smartphone or tablet with capabilities to download and use Flyte app.

• Willing and able to participate in follow-up.

Exclusion Criteria:

• Unable or unwilling to adhere to study requirements, including use of the Flyte System app during each daily treatment session, and to study-related follow-up requirements.

• Participation in another clinical study which may interfere with study requirements.

• No active cancer directed therapy (i.e., Cytotoxic chemotherapy) in post hysterectomy patients.

• 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 urethral and/or vesical 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.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 10/01/2025. Questions regarding updates should be directed to the study team contact.