Genitourinary Syndrome of Menopause (GSM), characterized by vaginal dryness, pain, urinary incontinence, and other symptoms, can be mitigated through both hormonal and non-hormonal treatments. Collagen peptides have shown promising results in improving skin, cartilage, and exhibiting antioxidative activities in studies. This study evaluates changes of quality of life and sexual function, related to vulvovaginal atrophy (VVA) and initial urinary incontinence (UI) in women with GSM symptoms, with the intake of a daily oral food supplement containing 2.5 g of Bioactive Collagen Peptides (BCP®) and other functional ingredients over a 16-week period . This can represent a new therapeutic option for these patients, particularly when hormonal therapy is not an option.
Genitourinary Syndrome of Menopause (GSM) includes a variety of symptoms related to the decline of circulating ovarian hormones. The syndrome is characterized by complaints of vaginal dryness, dyspareunia, pain, urinary incontinence, and recurrent urinary tract infections. Collagen hydrolysate (CH) has been used in pharmaceuticals and food supplements for improving skin and cartilage tissues. It is absorbed in the digestive tract, appears in the human blood partly in a small peptide form. Based on in vitro studies, collagen peptides (CPs) have shown to exert potent antioxidative activities in different oxidative systems. The purpose of this study is to evaluate the improvement of quality of life, vulvovaginal atrophy (VVA) and of initial Urinary Incontinence (UI) in menopausal women with GSM symptoms following oral administration of a food supplement treatment containing 2.5 g of BCP® and other functional ingredients taken once daily over a period of 16 weeks. The improvement of systemic health state and satisfaction with this supplement will be evaluated using both subjective and objective measures. The aim is also to identify significant improvement in quality of sexual function and health of genitourinary system.
Study Type
OBSERVATIONAL
Enrollment
43
The purpose of this study is to evaluate the improvement of quality of life, vulvovaginal atrophy (VVA) and of initial Urinary Incontinence (UI) in menopausal women with GSM symptoms following oral administration of a food supplement treatment containing 2.5 g of BCP® and other functional ingredients taken once daily over a period of 16 weeks.
Quality of life in patient with GSM
Evaluate the improvement of quality of life in relation to genitourinary symptoms, to evaluate acceptability and satisfaction with the use of collagen oral supplement in the treatment of Genitourinary Syndrome of Menopause (GSM). Quality of life will be evaluate through: QUOL questionnaire SF-12 (during visit T0 and T3). It's a 12-item questionnaire used to assess generic health outcomes from the patient's perspective like: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health.
Time frame: 24 weeks
Sexual function in patient with GSM
Evaluate the improvement of sexual function in relation to genitourinary symptoms, to evaluate acceptability and satisfaction with the use of collagen oral supplement in the treatment of Genitourinary Syndrome of Menopause (GSM) with: \- Female Sexual Function Index (FSFI - short form). FSFI has 19-item and includes: desire (2 items), arousal (4 items), lubrication (4 items), orgasm (3 items), satisfaction (3 items), and pain (3 items). The score scale range is from 0 (worse) to 30 (better score)
Time frame: 24 weeks
Evaluation of vaginal symptoms (included in genitourinary symptoms)
Evaluation of genitourinary symptoms (which include both vaginal symptoms and urinary incontinence symptoms). vaginal symptoms will be performed using the following tool: \- Visual Analog Scale (VAS) for the severity of atrophy symptoms (pain, dryness, irritation and leucorrhea), score 0 (better) - 10 (worse).
Time frame: 24 weeks
Evaluation of urinary symptoms (included in genitourinary symptoms)
Evaluation of genitourinary symptoms (which include both vaginal symptoms and urinary incontinence symptoms). urinary symptoms will be performed using the following tool: \- International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) where maximum score of 21 represents permanent incontinence.
Time frame: 24 weeks
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