Assessment of the Efficacy of Injectable Hyaluronic Acid for Genitourinary Syndrome of Menopause
Condition: Genitourinary Syndrome of Menopause
MeSH terms: Syndrome
Study type: Interventional

Summary: 
      The vaginal wall consists of epithelium, lamina propria, muscularis and adventitia (1). The
      decrease in postmenopausal estrogen levels causes thinning of the vaginal wall thickness and
      the development of genitourinary menopause syndrome (GSM), which is characterized by vaginal
      dryness, burning, pruritus, urinary complaints and sexual discomfort (2).

      In the treatment of GSM symptomatology, there are many different non-hormonal treatment
      options such as vaginal topical agents and energy-based devices, as well as estrogen-based
      hormonal therapies (3). The main problem with non-hormonal treatments is the short-term
      resolution of vaginal atrophy and the lack of long-term results, while contraindications such
      as breast cancer history and unwillingness of the women to use hormones are problematic for
      estrogen-based treatments.

      Considering all these issues, there is a search for new therapeutic agents with long and high
      efficiency and safety profile in the treatment of GSM. Hyaluronic acid (HA) which is one of
      the main components of the extracellular matrix and has water-binding property that provides
      moisturizing and lubricating effect (4). Besides, it is also reported as the key to the
      process of tissue regeneration through inflammation, cellular migration and angiogenesis (5).
      For these reasons, it seems to be a promising treatment of GSM symptomatology.

      HA has many routes of administration, such as vaginal gels, ovules, and suppositories, and
      studies have shown that locally applied HA preparations have a short-term therapeutic effect
      on GSM symptoms (6). However, there is no consensus regarding HA efficacy due to
      heterogeneity of studies. Since it is an endogenous molecule, it can be thought that it will
      be more effective if it is injected directly into the epithelium rather than locally applied.

      The injectable form of multifractional intercalated cross-linked HA (MIC-HA) (Armonia®,
      Regenyal, Italy) is designed for the reinforcement of the extracellular matrix in the female
      genital area. We intend to investigate and objectively evaluate the efficacy of MIC-HA
      injection on GSM symptoms and sexual functions in postmenopausal women.
    


Intervention name(s): Injectable form of multifractional intercalated cross-linked hyaluronic acid (Armonia®, Regenyal, Italy)
Intervention type(s): Device
Intervention description(s): 2 mL of Armonia 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
Keywords: vulvovaginal atrophy; hyaluronic acid; menopause; sexual dysfunction