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

NCT05571527 | Recruiting

• 1 other identifier: KanuniSSEAH3
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Genitourinary Syndrome of Menopause

Keywords

genitourinary syndrome; menopause; platelet rich plasma; vaginal atrophy

Outcome Measures

Primary Outcomes (5)

• 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 ]

Study Arms (2)

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.

Biological: Platelet Rich Plasma treatment

vaginal hyluronic acid supplement for GSM

ACTIVE COMPARATOR

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

Drug: Vaginal Hyaluronic Acid supplement

Interventions

Platelet Rich Plasma treatment BIOLOGICAL

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

Menopause patients having genitourinary syndrome (PRP)

Vaginal Hyaluronic Acid supplement DRUG

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

vaginal hyluronic acid supplement for GSM

Eligibility Criteria

• Age: 45 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital: lead

Study Sites (1)

Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, 34307, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Ozan Karadeniz, MD

CONTACT

+905333663003; dr.ozankrdnz@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 4, 2022
• First Posted: October 7, 2022
• Study Start: November 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 5, 2024

Record last verified: 2024-03

Locations

TU (1)