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

NCT05561972 | Completed

• 1 other identifier: 2020/900/87
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Genitourinary Syndrome of Menopause; Sexual Function Disturbances

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Turkish version of the Female Sexual Function Index

  The baseline and 4 weeks after intervention

Other Outcomes (1)

• Vaginal health index

  The baseline and 4 weeks after intervention

Interventions

injectable multifractional intercalated hyaluronic acid [Armonia®, Regenyal, Italy] DEVICE

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

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Maltepe University: lead

Study Sites (1)

Maltepe University Faculty of Medicine

Istanbul, 34844, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sexual Dysfunctions, Psychological

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: September 30, 2022
• Study Start: November 15, 2021
• Primary Completion: February 15, 2022
• Study Completion: March 15, 2022
• Last Updated: September 30, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)