Pilot Study to Evaluate Safety and Use of the Hyivy Vaginal Dilator Device After Radiation for Pelvic Cancers

What this Trial Is About

This research aims to evaluate a new vaginal dilator device called the Hyivy device in women who have undergone vaginal or pelvic radiation therapy for pelvic cancers such as endometrial, cervical, anal, or rectal cancer. The study focuses on assessing the safety and tolerability of this novel device while also examining its effects on health-related quality of life and pelvic pain. Vaginal stenosis, a narrowing or shortening of the vaginal canal caused by radiation, can lead to discomfort and tissue damage, and current treatments often have low adherence. Participants will use the Hyivy intravaginal device at home three times a week for 12 weeks. Each session includes 10 minutes of gentle heat between 37 and 39 degrees Celsius followed by 10 minutes of dilation. Participants are instructed not to use other dilators during the intervention period. The study is designed as a single-arm pilot to explore the feasibility and patient experience with this patient-controlled device. Throughout the study, participants will attend scheduled visits for assessments including safety and tolerability monitoring, quality of life questionnaires, and pelvic pain evaluations at baseline, 6 weeks, and 12 weeks. Adherence to the treatment protocol will also be tracked. The total intervention period is 12 weeks, and participants must be able to comply with device use and follow-up requirements. The researchers will review safety data and patient-reported outcomes to understand the devices impact and usability.

Feasibility of Hyivy Device Post-Radiation for Pelvic Malignancies