Hyivy Device in Post-radiation Patients

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05648253
• Other study ID #: Hyivy Health Inc-11 Nov 2022
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 30, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: Hyivy Health Inc
• Contact: Sabrina Collins, BSc
• Phone: (519) 749-4370
• Email: Sabrina.collins[@]grhosp.on.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 at least 2 weeks prior to starting the intervention, without concomitant chemotherapy
• 3.The participant is not of child-bearing potential, defined as females who have undergone a sterilization procedure (e.g., hysterectomy, bilateral oophorectomy, bilateral tubal ligation) or have been post-menopausal (natural or surgically) for at least 1 year prior to screening. Or, a participant of child-bearing potential must have a negative baseline urine pregnancy test and 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
• 4.Agrees not to commence any new treatments (medical or physical therapies) for the 12-week intervention period
• 5.Must have the ability to charge the investigational device
• 6.Must be willing and able to insert intravaginal device
• 7.Able to understand, comply and consent to protocol requirements and instructions
• 8.Able to attend scheduled study visits and complete required investigations
• 9.Eastern Cooperative Oncology Group (ECOG) of 0 to 2
• 10.Ability to understand and willingness to sign written informed consent
• 11.Healthy as determined by laboratory results, medical history, and physical exam as assessed by qualified investigator

Exclusion Criteria:

• 1.Participants who are pregnant or planning to become pregnant during the trial
• 2.Diagnosis of premature ovarian insufficiency
• 3.Has a condition rendering them unable to understand the nature, scope and possible consequences of the study, or evidence of an uncooperative attitude
• 4.Any major surgery in the past 3 months or anticipates having a major surgery during the study
• 5.Allergy to Hyivy device's materials (silicone, plastic, and/or metals)
• 6.Active vaginal infection (e.g., vulvovaginal candidiasis, trichomonas vaginitis, bacterial vaginosis, sexual transmitted infections) Current use of antibiotics and a history of vulvovaginal candidiasis

Related Conditions & MeSH terms

• Cancer
• Radiation Therapy

Intervention

Device:
• Vaginal Dilator Therapy by Hyivy device
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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hyivy Health Inc	Grand River Hospital

References & Publications (16)

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. — View Citation

Aslan M, Yavuzkir S, Baykara S. Is "Dilator Use" More Effective Than "Finger Use" in Exposure Therapy in Vaginismus Treatment? J Sex Marital Ther. 2020;46(4):354-360. doi: 10.1080/0092623X.2020.1716907. Epub 2020 Feb 13. — View Citation

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. — View Citation

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. — View Citation

Delgado D, White P, Trochez R, Drake MJ. A pilot randomised controlled trial of the pelvic toner device in female stress urinary incontinence. Int Urogynecol J. 2013 Oct;24(10):1739-45. doi: 10.1007/s00192-013-2107-x. Epub 2013 May 3. — View Citation

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.

Johnson N, Miles TP, Cornes P. Dilating the vagina to prevent damage from radiotherapy: systematic review of the literature. BJOG. 2010 Apr;117(5):522-31. doi: 10.1111/j.1471-0528.2010.02502.x. Epub 2010 Feb 16. — View Citation

Lanzafame RJ, de la Torre S, Leibaschoff GH. The Rationale for Photobiomodulation Therapy of Vaginal Tissue for Treatment of Genitourinary Syndrome of Menopause: An Analysis of Its Mechanism of Action, and Current Clinical Outcomes. Photobiomodul Photomed Laser Surg. 2019 Jul;37(7):395-407. doi: 10.1089/photob.2019.4618. Epub 2019 Jun 17. — View Citation

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. — View Citation

Liu M, Juravic M, Mazza G, Krychman ML. Vaginal Dilators: Issues and Answers. Sex Med Rev. 2021 Apr;9(2):212-220. doi: 10.1016/j.sxmr.2019.11.005. Epub 2020 Jan 31. — View Citation

Malanga GA, Yan N, Stark J. Mechanisms and efficacy of heat and cold therapies for musculoskeletal injury. Postgrad Med. 2015 Jan;127(1):57-65. doi: 10.1080/00325481.2015.992719. Epub 2014 Dec 15. — View Citation

Marques A, Stothers L, Macnab A. The status of pelvic floor muscle training for women. Can Urol Assoc J. 2010 Dec;4(6):419-24. doi: 10.5489/cuaj.10026. — View Citation

Nadler SF, Weingand K, Kruse RJ. The physiologic basis and clinical applications of cryotherapy and thermotherapy for the pain practitioner. Pain Physician. 2004 Jul;7(3):395-9. — View Citation

Ong TA, Khong SY, Ng KL, Ting JR, Kamal N, Yeoh WS, Yap NY, Razack AH. Using the Vibrance Kegel Device With Pelvic Floor Muscle Exercise for Stress Urinary Incontinence: A Randomized Controlled Pilot Study. Urology. 2015 Sep;86(3):487-91. doi: 10.1016/j.urology.2015.06.022. Epub 2015 Jul 2. Erratum In: Urology. 2017 Jan;99:294. — View Citation

Robinson JW, Faris PD, Scott CB. Psychoeducational group increases vaginal dilation for younger women and reduces sexual fears for women of all ages with gynecological carcinoma treated with radiotherapy. Int J Radiat Oncol Biol Phys. 1999 Jun 1;44(3):497-506. doi: 10.1016/s0360-3016(99)00048-6. — View Citation

Schover LR, Fife M, Gershenson DM. Sexual dysfunction and treatment for early stage cervical cancer. Cancer. 1989 Jan 1;63(1):204-12. doi: 10.1002/1097-0142(19890101)63:13.0.co;2-u. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The usability and satisfaction of the Hyivy device by study-specific questionnaire	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)	12 weeks
Secondary	Changes in quality of life	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.	12 weeks
Secondary	Changes in sexual function as assessed by the EORTC-SHQ-22	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.	12 weeks
Secondary	Changes in pelvic pain as assessed by visual analog scale (VAS).	Changes in pelvic pain as assessed by visual analog scale (VAS) ranging from 0 (no discomfort) to 10 (severe discomfort)	12 weeks
Secondary	Safety and tolerability of the Hyivy device as a non-hormonal therapy in post- radiation patients with pelvic malignancies as assessed by review of adverse events (AE) and serious adverse events (SAE).	Safety of the Hyivy device assessed by the Number of participants with treatment-related adverse events as assessed by CTCAE v4.0)	12 weeks
Secondary	The adherence of the Hyivy device assessed by participants' compliance	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%)	12 weeks