Vaginal StenosisNCT05648253
Feasibility of Hyivy Device Post-Radiation for Pelvic Malignancies
A study testing Hyivy Intravaginal Device in people with Vaginal Stenosis and Radiation Therapy, run by Hyivy Health Inc at 1 site in Canada.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vaginal Stenosis, Radiation Therapy, Cancer
- What is being tested?
- Hyivy Intravaginal Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 11 Apr 2025to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Grand River Regional Cancer Centre, Waterloo Regional Health Network @ Midtown
Kitchener, Ontario, N2G 1G3
Daniel Glick, 519-749-4370 ext. 5489, Daniel.Glick@grhosp.on.ca
About this study
Official title: 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.
Read the 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.
- Conditions
- Vaginal Stenosis, Radiation Therapy, Cancer, Pelvic Pain, Pelvic Cancer
- Being tested
- Hyivy Intravaginal Device
- Keywords
- Dilator, Post radiation therapy
- Medical subject headings
- Neoplasms, Pelvic Pain, Pelvic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyivy Intravaginal DeviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Hyivy Intravaginal Device | Experimental | 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. Receives: Device: Hyivy Intravaginal Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of the Hyivy device
Occurrence of adverse events (AE) and serious adverse events (SAE).
Measured: Up to 12-weeks
Secondary outcomes (3)
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).
Measured: Baseline, 6-weeks, 12-weeks
Pelvic pain (VAS)
Changes in pelvic pain as assessed by a visual analog scale (VAS).
Measured: 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.
Measured: 6-weeks, 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2022
- Study start11 Apr 2025
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Vaginal StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A prospective single-arm pre/post repeated-measures pilot study
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hyivy Health Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Waterloo Regional Health Network
- Responsible party
- Sponsor
- Investigators
- Daniel Glick, MD, Principal investigator, Waterloo Regional Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05648253
- Sponsor's protocol ID
- HYV-002-C23
- Status last verified
- Apr 2025
- First submitted
- 5 Dec 2022
- Last updated
- 22 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers
Publications
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.
PubMed 31302301International 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.
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.
PubMed 26164775Bakker 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.
PubMed 25424559Araya-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.
PubMed 32364016
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Assess the Feasibility of Use of a Novel Vaginal Dilator Device Post-radiation for Patients With Pelvic Malignancies
- ClinicalTrials.gov ID
- NCT05648253
- Acronym / sponsor ID
- HYV-002-C23
- Conditions
- Vaginal Stenosis, Radiation Therapy, Cancer, Pelvic Pain, Pelvic Cancer
- Keywords
- Dilator, Post radiation therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Hyivy Health IncIndustry (pharma, biotech, devices)
- Collaborators
- Waterloo Regional Health Network
- Study start
- 11 Apr 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 13 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A prospective single-arm pre/post repeated-measures pilot study
| Arm | Type | Receives |
|---|---|---|
| Hyivy Intravaginal Device | Experimental | Device: Hyivy Intravaginal DeviceParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyivy Intravaginal DeviceIntravaginal 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. | Device | Hyivy Intravaginal Device |
Primary outcome
Safety and tolerability of the Hyivy device
Time frame: Up to 12-weeks
Occurrence of adverse events (AE) and serious adverse events (SAE).
3 secondary outcomes
Quality of Life (FACT-G)
Time frame: Baseline, 6-weeks, 12-weeks
Pelvic pain (VAS)
Time frame: Baseline, 6-weeks, 12-weeks
Adherence to study protocol
Time frame: 6-weeks, 12-weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2025.
- Background: PubMed 31302301Damast 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.
- BackgroundInternational 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.
- Background: PubMed 26164775Law 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.
- Background: PubMed 25424559Bakker 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.
- Background: PubMed 32364016Araya-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.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers
Related trials for Vaginal Stenosis
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Relieves Vaginal Dryness / Improves Self-Lubrication, Improves Strength & Elasticity of Vagina (Aka Collagen and Elastin)
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Vaginal Dilator Therapy After Pelvic Radiation
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RecruitingObservational study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel Glick, MD principal investigator
Waterloo Regional Health Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyivy Intravaginal Device in people with Vaginal Stenosis and Radiation Therapy, run by Hyivy Health Inc at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Glick, MD ((519) 749-4370 ext. 5489, Daniel.Glick@grhosp.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of the Hyivy device (time frame: Up to 12-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05648253, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2025.