Clinical trial NCT05571527: Comparison of Vaginal Hyaluronic Acid Treatment Over Autologous Platelet Rich Plasma Treatment for Genitourinary Syndrome of Menopause
Official title: Comparison of Vaginal Hyaluronic Acid Treatment Over Autologous Platelet Rich Plasma Treatment for Genitourinary Syndrome of Menopause
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Genitourinary Syndrome of Menopause
Keywords: genitourinary syndrome
menopause
platelet rich plasma
vaginal atrophy
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2022-10-07
Enrollment: 60
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Vaginal health index score (VHIS)
timeFrame: [ Time Frame: 6 months after intervention ]
measure: The Vulvovaginal Symptom Questionnaire (VSQ)
timeFrame: [ Time Frame: 6 months after intervention ]
measure: Day-to-Day Impact of Vaginal Aging Questionnaire
timeFrame: [ Time Frame: 6 months after intervention ]
measure: vaginal maturation index
timeFrame: [ Time Frame: 6 months after intervention ]
measure: vaginal health index
timeFrame: [ Time Frame: 6 months after intervention ]
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Kanuni Sultan Suleyman Training and Research Hospital
Study officials:
References: