Ignite Creation Date:
2025-12-25 @ 5:18 AM
Ignite Modification Date:
2026-03-12 @ 10:38 AM
Study NCT ID:
NCT05571527
Status:
RECRUITING
Last Update Posted:
2024-03-05
First Post:
2022-10-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Vaginal Hyaluronic Acid Treatment Over Autologous Platelet Rich Plasma Treatment for Genitourinary Syndrome of Menopause
Sponsor:
Kanuni Sultan Suleyman Training and Research Hospital
Organization:
Study Overview
Official Title:
Comparison of Vaginal Hyaluronic Acid Treatment Over Autologous Platelet Rich Plasma Treatment for Genitourinary Syndrome of Menopause
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: