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

Kanuni Sultan Suleyman Training and Research Hospital1 个研究点分布在 1 个国家目标入组 60 人开始时间: 2023年11月1日最近更新: 2024年3月5日

适应症

干预措施

试验速览

阶段: 不适用
状态: 招募中
发起方: Kanuni Sultan Suleyman Training and Research Hospital
入组人数: 60
试验地点: 1
主要终点: vaginal health index

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Single (Participant)

入排标准

年龄范围: 45 Years 至 —（Adult, Older Adult）
性别: Female
接受健康志愿者: 是

入选标准

•Women with menopause
•Patients with symptoms of genitourinary syndrome of menopause

排除标准

•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.

研究组 & 干预措施

Menopause patients having genitourinary syndrome (PRP)

Experimental

Preparation of PRP sample from the patient's own blood and then the volume immediately above the erythrocyte layer was collected. Calcium gluconate in conc. 1:9 will be used as an activator. After activation, in a period of less than 2 min, approximately 4 ml of the PRP will be injected into the vaginal wall. ( at 3,6 and 9 o clock)It will be repeated once a month for 3 times.

干预措施: Platelet Rich Plasma treatment (Biological)

vaginal hyluronic acid supplement for GSM

Active Comparator

Patients receive Vaginal Hyaluronic Acid supplement for 10 days, then once a week for 3 months.

干预措施: Vaginal Hyaluronic Acid supplement (Drug)