Feasibility of Hyivy Device Post-Radiation for Pelvic Malignancies

Pilot Study to Assess the Feasibility of Use of a Novel Vaginal Dilator Device Post-radiation for Patients With Pelvic Malignancies

Vaginal dilator therapy (VDT) with static dilators is often prescribed to patients following vaginal or pelvic radiation therapy. This study seeks to evaluate the feasibility of a novel intravaginal device that delivers patient-controlled dilation (Hyivy device). The study is designed as a proof-of-concept single-arm pilot study. The primary objective is to assess safety and tolerability, while also evaluating changes in health-related quality of life and pelvic pain.

Radiation therapy is a common treatment for cancer in the pelvic area and is considered a mainstay of treatment for cancers of the cervix, uterus, and anorectum. Patients with a vagina and vaginal canal who undergo vaginal or pelvic radiation therapy are at risk for developing vaginal stenosis, defined in part by a shortening and/or narrowing of the vaginal canal, which can lead to damaged tissue and pain with examination/vaginal penetration.

Vaginal dilator therapy (VDT) is prescribed to prevent vaginal stenosis. Adherence to VDT in the months following radiation is quite low. Reasons may include limited size options of static dilators, lack of time, general fatigue, emotional well-being, and associating dilator use with underlying malignancy and radiation treatment. Alternatives to static dilators that are safe and effective may improve adherence to VDT and improve patient quality of life.

Inclusion Criteria:

• 1.Age ≥ 18 at the time of enrollment
• 2.Patient with a vagina or vaginal canal who have completed radiation therapy (either external beam or brachytherapy, or a combination of both) for endometrial cancer, cervical cancer, anal cancer, or rectal cancer, without concomitant chemotherapy
• 3.Generally in good health (other than due to cancer), at the discretion of the investigator(s)
• 4.Eastern Cooperative Oncology Group (ECOG) score or 0 to 2
• 5.Participants must be post-menopausal (natural or surgically) for at least 1 year prior to screening or be surgically sterile (absence of ovaries and/or uterus); or, a participant of child-bearing potential must agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months.
• 6.Agree not to use other dilators for the 12-week intervention period
• 7.Must have the ability to charge the investigational device
• 8.Must be willing and able to insert intravaginal device
• 9.Able to understand, comply and consent to protocol requirements and instructions
• 10.Able to attend scheduled study visits and complete required investigations
• 11.Ability to understand and willingness to sign written informed consent

Exclusion Criteria:

• 1.Participants who are pregnant or planning to become pregnant during the trial
• 2.Any major surgery in the past 3 months unless post-surgery dilator use is recommended by a physician, or anticipates having a major surgery during the study
• 3.Any other medical condition or clinical finding giving reasonable suspicion of a disease or condition that contraindicates the use of the investigational product or that may affect the interpretation of the results or leave the patient at high risk from treatment complications, at the discretion of the investigator(s)
• 4.Allergy to Hyivy device's materials
• 5.Active pelvic or gynaecological infection
• 6.Current use of antibiotics for any infection
• 7.Have open wounds, cuts, or open sores present in the vaginal or pelvic area
• 8.Severe atrophic vaginitis or very dry, itchy, or sore vagina/vaginal area, at the discretion of the investigator(s)
• 9.Hypoesthesia or loss in sensation of the pelvic floor
• 10.Total and/or partial prolapse of the uterus and/or vagina
• 11.Symptoms of severe urinary retention, severe extra-urethral incontinence, or overflow incontinence
• 12.Unable to position the device according to directions for use
• 13.Use of any medical devices that may interfere with the investigational device's function, such as pacemakers, ventilators, and ear implants