Genitourinary Syndrome of Menopause (GSM)
Conditions
Brief summary
This study evaluated whether adding platelet-rich plasma (PRP) to fractional CO₂ laser treatment provides additional benefit for postmenopausal women with genitourinary syndrome of menopause (GSM). Participants received either fractional CO₂ laser treatment alone or fractional CO₂ laser combined with PRP injections. Both groups received three treatment sessions at 4-6-week intervals. The main outcome was the change in vaginal dryness after treatment. Other outcomes included vaginal symptoms, sexual function, quality of life, and measures of vaginal health. The study also evaluated the safety and tolerability of both treatments.
Interventions
DEVICEFractional CO₂ Laser
Fractional laser treatment was performed using the DEKA DUOGlide GYN system (DEKA M.E.L.A., Florence, Italy), combining CO₂ (10,600 nm) and 1540 nm wavelengths. Three treatment sessions were performed at 4-6-week intervals.
BIOLOGICALAutologous Platelet-Rich Plasma (PRP)
Autologous PRP was prepared from 40 mL of peripheral blood using the OMNIPLEX Gyno kit, yielding approximately 3 mL of PRP with a platelet concentration approximately nine times baseline. PRP was injected into predefined vaginal sites immediately after each laser treatment.
Sponsors
National and Kapodistrian University of Athens
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Postmenopausal women, defined as more than 12 months of amenorrhea. * Diagnosis of genitourinary syndrome of menopause (GSM). * Vaginal dryness as the most bothersome GSM symptom. * Inadequate response or intolerance to previous GSM therapies, unwillingness to use hormonal treatment, or contraindication to hormonal therapy. * Ability and willingness to provide written informed consent and comply with the study protocol.
Exclusion criteria
* Use of systemic or local hormone therapy within 6 months before enrollment. * Stage II or higher pelvic organ prolapse according to the Pelvic Organ Prolapse Quantification (POP-Q) system. * Active genital tract infection. * History of gynecological or breast malignancy. * Cervical dysplasia. * Undiagnosed abnormal uterine bleeding. * Significant chronic medical condition that could interfere with compliance with the study protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Vaginal Dryness Severity | Baseline to 1 month after the final treatment session | Vaginal dryness severity was assessed using a 10-cm Visual Analog Scale (VAS), ranging from 0 (no symptoms) to 10 (worst possible symptoms). Change from baseline was compared between the two treatment groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in GSM Symptom Severity Assessed by Visual Analog Scale (VAS) | Baseline to 1 month after the final treatment session | Dyspareunia, vaginal itching, burning, and dysuria were assessed separately using a 10-cm Visual Analog Scale (VAS), ranging from 0 (no symptoms) to 10 (worst possible symptoms). |
| Change in Female Sexual Function Index (FSFI) Score | Baseline to 1 month after the final treatment session | Sexual function was assessed using the Female Sexual Function Index (FSFI), which evaluates six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. Higher total scores indicate better sexual function. |
| Change in Vaginal Health Index (VHI) Score | Baseline to 1 month after the final treatment session | Vaginal health was assessed clinically using the Vaginal Health Index (VHI). |
| Change in Vaginal Maturation Index (VMI) | Baseline to 1 month after the final treatment session | Vaginal epithelial maturation was assessed by vaginal cytology based on the relative proportions of parabasal, intermediate, and superficial squamous cells. |
| Change From Baseline in Vaginal pH | Baseline to 1 month after the final treatment session | Vaginal pH was assessed using indicator strips with a measurement range of 4 to 7. |
| Change From Baseline in Day-to-Day Impact of Vaginal Aging (DIVA) Score | Baseline to 1 month after the final treatment session | The DIVA questionnaire was used to assess the impact of vaginal symptoms across four domains: activities of daily living, emotional well-being, sexual functioning, and self-concept/body image. Higher scores indicate greater impact of symptoms. |
Countries
Greece
Outcome results
None listed