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

Kanuni Sultan Suleyman Training and Research Hospital

Status: Enrolling

Conditions: Genitourinary Syndrome of Menopause

Treatments: Drug: Vaginal Hyaluronic Acid supplement; Biological: Platelet Rich Plasma treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT05571527

KanuniSSEAH3

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 45+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Menopause patients having genitourinary syndrome (PRP)

Experimental group

Description:

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.

Treatment:

Biological: Platelet Rich Plasma treatment

vaginal hyluronic acid supplement for GSM

Active Comparator group

Description:

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

Treatment:

Drug: Vaginal Hyaluronic Acid supplement