Symptoms and General Pathology

All Conditions

Constriction, Pathologic

Participants will receive a Hyivy device with both verbal and written instructions. Recommended use is three times per week for 12 weeks and consists of: 10 minutes of heat (37-42ºC) per session and 10 minutes of dilation per session

Intravaginal use of Hyivy device three times per week for 12 weeks, with each use session consisting of: 10 minutes of heat (37-42ºC) and 10 minutes of dilation therapy

Vaginal Dilator Therapy by Hyivy device

Sabrina Collins, BSc

Tea Lulic, PhD

Daniel Glick, MD

The objective of this study is to evaluate the feasibility of using the Hyivy device as a non-hormonal therapy in post-radiation patients with pelvic malignancies

Prior to study enrollment, all prospective participants will have the ability to contact the study team to learn more about the study and be provided with the relevant study-specific information. After being informed about the study and potential risks, all participants giving written informed consent will be assessed for their eligibility for the study, and enrolled participants will undergo a maximum 30-day screening period. On Day 0, eligible participants will start a 12-week use of Hyivy device with one visit on Week 6-7 and another on Week 12. After completing the 12-week intervention period, a virtual follow-up will be conducted on Week 16.

A prospective single-arm pre/post repeated-measures pilot intervention study

Hyivy Device in Post-radiation Patients

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

There is no plan to make individual participant data available to other researchers

The usability and satisfaction of the Hyivy device for Hyivy's product development as assessed by study-specific questionnaires ranging from 11 (worst usability and satisfaction) to 55 (best usability and satisfaction)

Changes in quality of life as assessed by the European Organization for Research and Treatment of Cancer (EORTC)-QLQ-C30. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status indicate a better state of the patient, while higher scores on the symptom and single-item scales indicate a worse state of the patient.

Changes in sexual function as assessed by the EORTC-SHQ-22. The EORTC-SHQ-22 score range is from 0 to 100; a higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms.

Changes in pelvic pain as assessed by visual analog scale (VAS) ranging from 0 (no discomfort) to 10 (severe discomfort)

Safety of the Hyivy device assessed by the Number of participants with treatment-related adverse events as assessed by CTCAE v4.0)

Adherence to the study regimen as assessed by comparing usage data collected by the Hyivy device to the recommended intervention regimen(adherence rate = # of times of patients did dilation therapy/# of times of patients should do dilation therapy \*100%)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Hyivy Device in Post-radiation Patients	NCT05648253	Vaginal Stenosi... Radiation Thera... Cancer	Vaginal Dilator...	18 Years -	Hyivy Health Inc
Hyivy Device in Post-radiation Patients	NCT05648253	Vaginal Stenosi... Radiation Thera... Cancer	Vaginal Dilator...	18 Years -	Hyivy Health Inc

Spots Global Cancer Trial Database for post radiation therapy