Genitourinary Syndrome of Menopause (GSM)
Conditions
Brief 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.
Interventions
BIOLOGICALAutologous 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.
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.
Sponsors
National and Kapodistrian University of Athens
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
The pathologist performing histological and morphometric assessment was blinded to the intervention assigned to each biopsy site. Participants and the treating investigator were not blinded.
Intervention model description
Within-participant (split-vagina) controlled design. Each participant received PRP injection, 0.9% normal saline injection and no intervention in three predefined vaginal regions (right half of the anterior vaginal wall, left half of the anterior vaginal wall and posterior vaginal wall). Interventions were assigned to regions according to a predetermined, non-randomized cyclic rotation across consecutive participants, and each region retained the same assignment at both treatment sessions.
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
Postmenopausal women with at least one genitourinary symptom and clinical evidence of vaginal atrophy, defined as a Vaginal Health Index Score (VHIS) \<15, were consecutively recruited from the Urogynecology Unit of Alexandra General Hospital. Eligible women had concomitant pelvic organ prolapse of stage II or greater according to the Pelvic Organ Prolapse Quantification (POP-Q) system and were scheduled for reconstructive prolapse surgery. Postmenopausal status was defined as at least 12 months of amenorrhea. All participants were required to provide written informed consent and comply with the study procedures and follow-up schedule.
Exclusion criteria
systemic or local hormonal therapy within the preceding three months; vulvovaginal dermatoses; lower genital tract neoplasia or gynecological malignancy; previous pelvic irradiation; active genital or urinary tract infection; chronic pelvic pain; pelvic surgery within the preceding six months; known hypersensitivity to study-related medications or materials; clinically significant hematological abnormalities; immunosuppression; uncontrolled systemic disease; or any other condition judged by the investigators to compromise participation or outcome assessment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Epithelial thickness | Week 8 (4 weeks after the second treatment session), at the time of prolapse surgery | Mean vaginal epithelial thickness (μm) measured by digital morphometry on hematoxylin and eosin-stained sections (mean of five non-overlapping fields per biopsy, ×10), compared between PRP-treated, saline-treated and no intervention sites within participants. |
| Vascular density of the lamina propria | Week 8 (4 weeks after the second treatment session), at the time of prolapse surgery | Number of factor VIII-positive vessels per mm² of lamina propria on immunohistochemistry (mean of five non-overlapping fields per biopsy, ×10), compared between PRP-treated, saline-treated and no intervention sites within participants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Epithelial glycogen area fraction | Week 8 (4 weeks after the second treatment session), at the time of prolapse surgery | Glycogen area fraction (%) of the epithelium on periodic acid-Schiff-stained sections (mean of five fields, ×10), compared between PRP-treated, saline-treated and no intervention sites within participants. |
| Epithelial proliferative activity | Week 8 (4 weeks after the second treatment session), at the time of prolapse surgery | Density of Ki-67-positive basal and parabasal epithelial cells (cells/mm² of epithelium), compared between PRP-treated, saline-treated and no intervention sites within participants. |
| Subepithelial papillae | Week 8 (4 weeks after the second treatment session), at the time of prolapse surgery | Number of subepithelial papillae per microscopic field at ×10 (mean of five fields), compared between PRP-treated, saline-treated and no intervention sites within participants. |
| Collagen Architecture Score | Week 8 (4 weeks after the second treatment session), at the time of prolapse surgery | Study-specific semiquantitative score on Masson's trichrome-stained sections (×20): trabecular organization, bundle thickness/definition and stromal connectivity, each graded 0-2 (field score 0-6; higher scores indicate more organized collagen); biopsy score is the mean of five fields. Compared between PRP-treated, saline-treated and no intervention sites within participants. |
Countries
Greece
Outcome results
None listed