The Ultrasonographic Assessment of Efficacy of Injectable Hyaluronic Acid for Genitourinary Syndrome of Menopause

Sponsor

Maltepe University (Other)

Overall Status

Completed

CT.gov ID

NCT05561972

Collaborator

(none)

Enrollment

Location

3.9

Actual Duration (Months)

7.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Genitourinary syndrome of menopause (GSM) is a definition including vaginal dryness, burning, vaginal pruritus, dyspareunia and urinary symptoms which can have a negative effect on women's sexuality and quality of life. The most common strategies to overcome GSM are non-hormonal (vaginal lubricants, topical moisturizers, energy-based devices etc.) and hormonal therapies. While vaginal lubricants are used during sexual intercourse and have temporary effects on vaginal epithelium, vaginal moisturizers are "bio-adhesive" products that can improve vaginal atrophy symptoms when used regularly. These products have not serious side effects but long-term effectiveness is not established. In the last decade, energy-based devices like laser and radiofrequency were used for treatment of GSM. Nevertheless, side effects and safety problems associated with these methods lead to uncertainty about the use of these methods in GSM therapy. Local and systemic estrogen therapies have been widely used for decades, but there is limited data on the persistence of the effect after estrogen use is stopped.

Hyaluronic acid (HA) is a glycosaminoglycan molecule that is an essential element of the extracellular matrix, with water-retention properties and regulatory effects on inflammation, scarring, and angiogenesis]. To date, many studies reported short-term improving effects of topical HA on GSM symptoms and have used subjective assessment of sexual symptoms and vaginal health scoring tools to investigate the effect of vaginal use of topical HA. However, since the injection of HA into the vagina will have a direct effect on the vaginal epithelium, it would be reasonable to expect a longer efficacy on GSM symptoms.

The methods used to diagnose GSM are subjective or provide unreliable objective evidence. Recently demonstrated as an objective diagnostic tool for GSM, 3D high frequency vaginal ultrasound (3D-HFVU) was used to separately measure anterior vaginal wall (ant-VWT) and posterior vaginal wall thickness (post-VWT) in contrast to 2D ultrasonography. To date, there are no studies to evaluate the effect of HA injection on the vaginal epithelium ultrasonographically.

The aim of the study was to investigate the effect of multifractional intercalated HA (MIC-HA) [Armonia®, Regenyal, Italy] injection on ant-VWT and post-VWT using 3D-HFVU, and also to assess the relationship between sexual functions and VWT increase in women with GSM after the injection. This is the first study to assess the effect of vaginal injection of MIC-HA on ant-VWT and post-VWT separately using 3D-HFVU.

Condition or Disease	Intervention/Treatment	Phase
Genitourinary Syndrome of Menopause Sexual Function Disturbances	Device: injectable multifractional intercalated hyaluronic acid [Armonia®, Regenyal, Italy]	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

31 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Assessment of the Efficacy Of Multifractional Intercalated Hyaluronic Acid Injection for Genitourinary Syndrome of Menopause Using 3D High Frequency Vaginal Ultrasound

Actual Study Start Date :

Nov 15, 2021

Actual Primary Completion Date :

Feb 15, 2022

Actual Study Completion Date :

Mar 15, 2022

Outcome Measures

Primary Outcome Measures

Change from baseline anterior and posterior vaginal wall thickness at 4 weeks as detected by 3D high-frequency endovaginal ultrasound [The baseline and 4 weeks after intervention]

Secondary Outcome Measures

Turkish version of the Female Sexual Function Index [The baseline and 4 weeks after intervention]

Other Outcome Measures

Vaginal health index [The baseline and 4 weeks after intervention]

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:Postmenopausal women who had vaginal irritation, burning, vaginal pruritus, dryness and dyspareunia -

Exclusion Criteria:The presence of pelvic organ prolapse greater than stage I, vulvovaginitis, genital carcinoma, previous vaginal surgery, current use of vaginal moisturizers or lubricants, local or systemic estrogen treatment and antidepressant use, women those with known hypersensitivity to hyaluronic acid, betadine or lidocaine

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maltepe University Faculty of Medicine	İstanbul		Turkey	34844

Sponsors and Collaborators

Maltepe University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Maltepe University

ClinicalTrials.gov Identifier:

NCT05561972

Other Study ID Numbers:

2020/900/87

First Posted:

Sep 30, 2022

Last Update Posted:

Sep 30, 2022

Last Verified:

Sep 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Syndrome

Hyaluronic Acid

Study Results

No Results Posted as of Sep 30, 2022