Comparison of Vaginal Hyaluronic Acid Treatment Over Autologous Platelet Rich Plasma Treatment for Genitourinary Syndrome of Menopause

Kanuni Sultan Suleyman Training and Research Hospital60 enrolled

Overview

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.

PRIMARY OBJECTIVE: To determine the safety and feasibility of using platelet-rich plasma (PRP) treatment in menopausal patients with genitourinary syndrome SECONDARY OBJECTIVE: To determine the preliminary efficacy in the treatment of vaginal atrophy, urinary symptoms, assessment of sexual function, quality of life symptoms VSQ, Vaginal health index, Vaginal maturation index, and Day-to-Day Impact of Vaginal Aging score will be used for assessments. OUTLINE: Patients receive platelet-rich plasma via injection into the vaginal area after obtaining plasma into PRP tubes After 3 sessions of PRP treatment, patients are followed up for 6 months.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Genitourinary Syndrome of Menopause

Eligibility

Sex: FEMALEMin age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Vaginal health index score (VHIS)

evaluation of vaginal elasticity, secretions, pH, the presence of petechiae on the epithelial mucosa, and hydration