An interventional study of injectable multifractional intercalated hyaluronic acid [Armonia®, Regenyal, Italy] in Genitourinary Syndrome of Menopause and Sexual Function Disturbances, sponsored by Maltepe University. Completed at 1 site in Turkey. Open to female participants aged 45 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-30.
Sponsored by Maltepe University · Not applicable, Interventional, and Treatment
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.
9,217 studies on the registry are indexed under Syndrome; 1,034 are open to participants now.
This study's enrollment of 31 is below the median of 50 across 6,517 interventional studies indexed under Syndrome.
Browse Syndrome studies →Maltepe University is the lead sponsor of 62 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
-
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
Change from baseline anterior and posterior vaginal wall thickness at 4 weeks as detected by 3D high-frequency endovaginal ultrasound
Time frame: The baseline and 4 weeks after intervention
Turkish version of the Female Sexual Function Index
Time frame: The baseline and 4 weeks after intervention
Vaginal health index
Time frame: The baseline and 4 weeks after intervention
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Maltepe University