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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Intravaginal use of Hyivy device three times per week for 12 weeks, with each session consisting of 10 minutes of heat (37-39ºC) and 10 minutes of dilation.
Grand River Regional Cancer Centre, Waterloo Regional Health Network @ Midtown
Kitchener, Ontario, Canada
RECRUITINGSafety and tolerability of the Hyivy device
Occurrence of adverse events (AE) and serious adverse events (SAE).
Time frame: Up to 12-weeks
Quality of Life (FACT-G)
Changes in health-related quality of life (HRQoL) as assessed by the Functional Assessment of Cancer Therapy - General (FACT-G).
Time frame: Baseline, 6-weeks, 12-weeks
Pelvic pain (VAS)
Changes in pelvic pain as assessed by a visual analog scale (VAS).
Time frame: Baseline, 6-weeks, 12-weeks
Adherence to study protocol
Usage data collected by the Hyivy device will be used to assess participant adherence to the study regimen of 3 times/week device use.
Time frame: 6-weeks, 12-weeks
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