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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05561972
Other study ID # 2020/900/87
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 15, 2021
Est. completion date March 15, 2022

Study information

Verified date September 2022
Source Maltepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date March 15, 2022
Est. primary completion date February 15, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 45 Years to 65 Years
Eligibility 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 -

Study Design


Related Conditions & MeSH terms


Intervention

Device:
injectable multifractional intercalated hyaluronic acid [Armonia®, Regenyal, Italy]
Armonia® 2 ml was injected into the vaginal wall with a standardized injection technique called Cannulated Intravaginal Injection Technique®. In this technique, Armonia® was injected as drops at 40 different points on the entire vaginal wall using 8 different entry points

Locations

Country Name City State
Turkey Maltepe University Faculty of Medicine Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Maltepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Other Vaginal health index The baseline and 4 weeks after intervention
Primary 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 Turkish version of the Female Sexual Function Index The baseline and 4 weeks after intervention
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