Clinical Research Directory
Browse clinical research sites, groups, and studies.
Vaginal Platelet-Rich Plasma and Vaginal Histology in Genitourinary Syndrome of Menopause
Sponsor: National and Kapodistrian University of Athens
Summary
This study evaluates whether subepithelial injection of autologous platelet-rich plasma (PRP) into the vaginal wall produces histological changes consistent with tissue regeneration in postmenopausal women with genitourinary syndrome of menopause (GSM). Women with GSM and concomitant pelvic organ prolapse who were scheduled for reconstructive prolapse surgery received two treatment sessions four weeks apart. Within each participant, three predefined vaginal regions received PRP injection, normal saline injection or no intervention. At the time of prolapse surgery, four weeks after the second session, biopsies were obtained from all three regions and assessed by a pathologist blinded to treatment allocation. Epithelial thickness, epithelial glycogen content, epithelial proliferative activity, vascular density, subepithelial papillae and collagen architecture were compared among the three sites.
Official title: Histological Effects of Subepithelial Vaginal Platelet-Rich Plasma for Women With Genitourinary Syndrome of Menopause and Pelvic Organ Prolapse: A Prospective Split-Vagina Controlled Study
Key Details
Gender
FEMALE
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2023-04-01
Completion Date
2026-07-31
Last Updated
2026-10-29
Healthy Volunteers
No
Interventions
Autologous Platelet-Rich Plasma (PRP)
Leukocyte-poor autologous PRP prepared immediately before each session from 40 mL of peripheral venous blood using the OMNIPLEX Gyno kit (two-step centrifugation: 3200 rpm for 4 min, then 4000 rpm for 20 min), without exogenous activation. Administered subepithelially with a 30-gauge needle as 40 injections of 0.1 mL (4 mL total) into the assigned vaginal region, in two sessions four weeks apart.
0.9% sodium chloride (normal saline)
Subepithelial injection of 4 mL of 0.9% normal saline (40 injections of 0.1 mL) into the assigned vaginal region, using the same technique and schedule as PRP; injection control.
Locations (1)
Alexandra General Hospital
Athens, Greece