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

NCT ID: NCT05571527

Last Updated: 2024-03-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2024-12-01

Brief Summary

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

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.

Conditions

Genitourinary Syndrome of Menopause

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Menopause patients having genitourinary syndrome (PRP)

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.

Group Type: EXPERIMENTAL

Platelet Rich Plasma treatment

Intervention Type: BIOLOGICAL

Patients receive platelet-rich plasma via injection into the vaginal area.

vaginal hyluronic acid supplement for GSM

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

Group Type: ACTIVE_COMPARATOR

Vaginal Hyaluronic Acid supplement

Intervention Type: DRUG

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

Interventions

Platelet Rich Plasma treatment

Patients receive platelet-rich plasma via injection into the vaginal area.

Intervention Type: BIOLOGICAL

Vaginal Hyaluronic Acid supplement

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Kanuni Sultan Suleyman Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ozan Karadeniz

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Ozan Karadeniz, MD

Role: CONTACT

dr.ozankrdnz@gmail.com

+905333663003

Facility Contacts

Ozan Karadeniz

Role: primary

dr.ozankrdnz@gmail.com

+905333663003

Other Identifiers

KanuniSSEAH3

Identifier Type: -

Identifier Source: org_study_id