Genitourinary Syndrome of Menopause
Conditions
Keywords
genitourinary syndrome, menopause, platelet rich plasma, vaginal atrophy
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.
Interventions
BIOLOGICALPlatelet Rich Plasma treatment
Patients receive platelet-rich plasma via injection into the vaginal area.
DRUGVaginal Hyaluronic Acid supplement
Patients receive Vaginal Hyaluronic Acid supplement for 10 days, then once a week for 3 months.
Sponsors
Kanuni Sultan Suleyman Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vaginal health index score (VHIS) | [ Time Frame: 6 months after intervention ] | evaluation of vaginal elasticity, secretions, pH, the presence of petechiae on the epithelial mucosa, and hydration |
| The Vulvovaginal Symptom Questionnaire (VSQ) | [ Time Frame: 6 months after intervention ] | symptoms, emotions, life-impact, and sexual impact of vulvovaginal symptoms. |
| Day-to-Day Impact of Vaginal Aging Questionnaire | [ Time Frame: 6 months after intervention ] | Measure of the Impact of Vaginal Symptoms on Functioning and Well-being in Postmenopausal Women |
| vaginal maturation index | [ Time Frame: 6 months after intervention ] | objective, qualitative assessment of vaginal response to hormones as well as overall hormonal environment. |
| vaginal health index | [ Time Frame: 6 months after intervention ] | clinical tool that, by evaluating 5 parameters (vaginal elasticity, vaginal secretions, pH, epithelial mucous membrane, vaginal hydration) |
Countries
Turkey (Türkiye)
Contacts
Primary ContactOzan Karadeniz, MD
Outcome results
None listed