The Ultrasonographic Assessment of Efficacy of Injectable Hyaluronic Acid for Genitourinary Syndrome of Menopause
Condition: Genitourinary Syndrome of Menopause; Sexual Function Disturbances
MeSH terms: Syndrome
Study type: Interventional

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.
    


Intervention name(s): injectable multifractional intercalated hyaluronic acid [Armonia®, Regenyal, Italy]
Intervention type(s): Device
Intervention description(s): 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
Intervention MeSH terms: Hyaluronic Acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment