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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Genitourinary Syndrome of Menopause

Intervention / Treatment
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* Biological: Platelet Rich Plasma treatment
* Drug: Vaginal Hyaluronic Acid supplement


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Menopause patients having genitourinary syndrome (PRP)<br>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. | Biological: Platelet Rich Plasma treatment<br>* Patients receive platelet-rich plasma via injection into the vaginal area.<br>|
| Active Comparator: vaginal hyluronic acid supplement for GSM<br>Patients receive Vaginal Hyaluronic Acid supplement for 10 days, then once a week for 3 months. | Drug: Vaginal Hyaluronic Acid supplement<br>* Patients receive Vaginal Hyaluronic Acid supplement for 10 days, then once a week for 3 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 ] | 
| The Vulvovaginal Symptom Questionnaire (VSQ) | symptoms, emotions, life-impact, and sexual impact of vulvovaginal symptoms. | [ Time Frame: 6 months after intervention ] | 
| 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 ] | 
| vaginal maturation index | objective, qualitative assessment of vaginal response to hormones as well as overall hormonal environment. | [ Time Frame: 6 months after intervention ] | 
| 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 ] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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genitourinary syndrome, menopause, platelet rich plasma, vaginal atrophy