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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| vaginal hyluronic acid supplement for GSM | Active Comparator | Patients receive Vaginal Hyaluronic Acid supplement for 10 days, then once a week for 3 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Platelet Rich Plasma treatment | Biological | Patients receive platelet-rich plasma via injection into the vaginal area. |
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| 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 ] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ozan Karadeniz, MD | Contact | +905333663003 | dr.ozankrdnz@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kanuni Sultan Suleyman Training and Research Hospital | Recruiting | Istanbul | 34307 | Turkey (Türkiye) |
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| Vaginal Hyaluronic Acid supplement | Drug | Patients receive Vaginal Hyaluronic Acid supplement for 10 days, then once a week for 3 months. |
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