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.

Study Overview

• Status: Recruiting
• Conditions: Cancer; Pelvic Cancer; Pelvic Pain; Radiation Therapy; Vaginal Stenosis
• Intervention / Treatment: Device: Hyivy Intravaginal Device

Detailed Description

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
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniel Glick, MD; Phone Number: 5489 (519) 749-4370; Email: Daniel.Glick@grhosp.on.ca

Study Locations

• Canada
  • Ontario
    • Kitchener, Ontario, Canada, N2G 1G3
      • Recruiting
      • Grand River Regional Cancer Centre, Waterloo Regional Health Network @ Midtown
      • Contact: Daniel Glick; Phone Number: 5489 519-749-4370; Email: Daniel.Glick@grhosp.on.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hyivy Intravaginal Device; Participants will receive a Hyivy intravaginal device for at-home use. Recommended use is three times per week for 12 weeks and consists of 10 minutes of heat (37-39ºC) and 10 minutes of dilation per session.	Device: Hyivy Intravaginal Device; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and tolerability of the Hyivy device	Occurrence of adverse events (AE) and serious adverse events (SAE).	Up to 12-weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6-weeks, 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).	Baseline, 6-weeks, 12-weeks
Pelvic pain (VAS)	Changes in pelvic pain as assessed by a visual analog scale (VAS).	Baseline, 6-weeks, 12-weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device usability and patient satisfaction	Study-specific questionnaire to gather patient feedback	12-weeks

Collaborators and Investigators

• Sponsor: Hyivy Health Inc
• Collaborators: Grand River Hospital
• Investigators: Principal Investigator: Daniel Glick, MD, Grand River Hospital

Publications and helpful links

General Publications

• Law E, Kelvin JF, Thom B, Riedel E, Tom A, Carter J, Alektiar KM, Goodman KA. Prospective study of vaginal dilator use adherence and efficacy following radiotherapy. Radiother Oncol. 2015 Jul;116(1):149-55. doi: 10.1016/j.radonc.2015.06.018. Epub 2015 Jul 8.
• Araya-Castro P, Sacomori C, Diaz-Guerrero P, Gayan P, Roman D, Sperandio FF. Vaginal Dilator and Pelvic Floor Exercises for Vaginal Stenosis, Sexual Health and Quality of Life among Cervical Cancer Patients Treated with Radiation: Clinical Report. J Sex Marital Ther. 2020;46(6):513-527. doi: 10.1080/0092623X.2020.1760981. Epub 2020 May 2.
• Bakker RM, Vermeer WM, Creutzberg CL, Mens JW, Nout RA, Ter Kuile MM. Qualitative accounts of patients' determinants of vaginal dilator use after pelvic radiotherapy. J Sex Med. 2015 Mar;12(3):764-73. doi: 10.1111/jsm.12776. Epub 2014 Nov 25.
• Damast S, Jeffery DD, Son CH, Hasan Y, Carter J, Lindau ST, Jhingran A. Literature Review of Vaginal Stenosis and Dilator Use in Radiation Oncology. Pract Radiat Oncol. 2019 Nov;9(6):479-491. doi: 10.1016/j.prro.2019.07.001. Epub 2019 Jul 11.
• International Clinical Guideline Group. International Guidelines on Vaginal Dilation after Pelvic Radiotherapy.; 2012. https://owenmumford.com/us/wp-content/uploads/sites/3/2014/11/Dilator-Best-Practice-Guidelines.pdf.

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: December 5, 2022
• First Submitted That Met QC Criteria: December 5, 2022
• First Posted (Actual): December 13, 2022

Study Record Updates

• Last Update Posted (Actual): April 22, 2025
• Last Update Submitted That Met QC Criteria: April 17, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Dilator; Post radiation therapy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neoplasms by Site; Neoplasms; Pelvic Neoplasms; Pelvic Pain
• Other Study ID Numbers: HYV-002-C23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to make individual participant data available to other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No