Genitourinary Syndrome of Menopause Clinical Trial
Official title:
Comparison of Vaginal Hyaluronic Acid Treatment Over Autologous Platelet Rich Plasma Treatment for Genitourinary Syndrome of Menopause
Genitourinary syndrome of menopause (GSM) is a collection of symptoms and signs caused by hypoestrogenic changes to the labia majora/minora, clitoris, vestibule/introitus, vagina, urethra, and bladder that occur in menopausal patients. Platelet-rich plasma is produced by collecting approximately 60-90 ml (4-6 tablespoons) of blood from the vein in patient's arm. The blood is spun using a centrifuge that separates the plasma and red blood cells. The treatment included vaginal estrogen supplement, vaginal hyaluronic acid supplement, vaginal laser, platelet-rich plasma, etc. The observational cohort study will be used for the study design. Questionnaires, pelvic examination, vaginal pap smear with maturation index (MI), vaginal pH, and other methods will be used to evaluate the effectiveness and side effects.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 1, 2024 |
Est. primary completion date | March 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 45 Years and older |
Eligibility | Inclusion Criteria: - Women with menopause - Patients with symptoms of genitourinary syndrome of menopause Exclusion Criteria: - Genitourinary bleeding or infection without a definitive diagnosis - Coagulopathy - Allergy to medication or therapy related to the treatment - Chronic disease that might influence the outcome - Using medication that might influence the outcome in 30 days - Using hormone or steroid within 8 weeks - Personal history of vulvovaginal conditions such as lichen sclerosis, lichen planus, vulvovaginal condyloma, vaginal intraepithelial neoplasia, vaginal carcinoma, history of cervical or other gynecologic cancer, radical pelvic surgery, acute or recurrent urinary tract infection, genital infection, history of vaginal or pelvic radiation - Chronic pelvic pain, current pelvic tension myalgia/muscle hypertonicity - Pelvic organ prolapse greater than stage II - Pelvic surgery within 6 months - Known allergy to lidocaine or prilocaine - Use of vaginal moisturizers, lubricants, or homeopathic preparations within 2 weeks of therapy - Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy. |
Country | Name | City | State |
---|---|---|---|
Turkey | Kanuni Sultan Suleyman Training and Research Hospital | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Kanuni Sultan Suleyman Training and Research Hospital |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Vaginal health index score (VHIS) | evaluation of vaginal elasticity, secretions, pH, the presence of petechiae on the epithelial mucosa, and hydration | [ Time Frame: 6 months after intervention ] | |
Primary | The Vulvovaginal Symptom Questionnaire (VSQ) | symptoms, emotions, life-impact, and sexual impact of vulvovaginal symptoms. | [ Time Frame: 6 months after intervention ] | |
Primary | Day-to-Day Impact of Vaginal Aging Questionnaire | Measure of the Impact of Vaginal Symptoms on Functioning and Well-being in Postmenopausal Women | [ Time Frame: 6 months after intervention ] | |
Primary | vaginal maturation index | objective, qualitative assessment of vaginal response to hormones as well as overall hormonal environment. | [ Time Frame: 6 months after intervention ] | |
Primary | vaginal health index | clinical tool that, by evaluating 5 parameters (vaginal elasticity, vaginal secretions, pH, epithelial mucous membrane, vaginal hydration) | [ Time Frame: 6 months after intervention ] |
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