Postmenopausal vulvovaginal atrophy
Hamid 2025Value of injection of plasma-rich platelets in the vaginal mucosa in cases with vulvovaginal atrophy: a prospective double-blinded randomized controlled study.
There is growing interest in the use of several innovative technologies being routinely used for facial skin care and skin rejuvenation for the treatment of genital disorders resulting from the aging process or with inflammation-related origins. This includes the use of PRP.
Postmenopausal vulvovaginal atrophy (VVA) is due to hypoestrogenic state that leads to anatomical, histological, and physiological changes that affects the lower genital and urinary tract.
VVA is manifested by genital dryness, burning, irritation and sexual dysfunction. VVA affects 67%–98% of the menopausal women and is associated with psychosocial distress and sexual dysfunction leading to negative impact on the quality of life of the patients.
OBJECTIVE
Assess the efficacy of RegenPRP™ injections in alleviating VVA symptoms in postmenopausal women.
PROTOCOL
Prospective double-blinded randomized controlled clinical trial on 60 women experiencing vaginal atrophy. Thirty participants received a single session of intramucosal RegenPRP™ injections, while the other 30 received saline injections as a placebo. Clinical evaluations were performed after 4 months using the Female Sexual Function Index (FSFI) and the 36-item short-form survey (SF-36) for the evaluation of quality of life. Four ml of RegenPRP™ were injected into the first 3 cm of the posterior vaginal wall and the posterior introitus. The injections were performed using a point-by-point technique, injecting 0.4 ml at each site every 5 mm, employing a 27G needle and a 1 ml syringe.
RESULTS
After 4 months significant improvement in FSFI scores were observed in the RegenPRP™ group while it remained stable in the saline group (mean improvement 9.8 ± 2.7 vs. -0.1 ± 0.6, P < 0.001, respectively). More specifically, improvements compared to baseline were seen for lubrication (2.26 ± 0.99 vs. 1.15 ± 0.81, P = 0.02), satisfaction (5.27 ± 0.63 vs. 1.31 ± 0.78, P < 0.001), and pain (5.18 ± 0.59 vs. 2.51 ± 1.63, P < 0.001) scores in the RegenPRP™ group, see figure 1. Except for the physical functioning score that was already at 100 at baseline for both groups, all the other SF36 scores improved significantly (p < 0.001) in the RegenPRP™ group, while no improvements were observed for all these scores in the placebo group.
Mean improvement in total FSFI score
Reported change: 9.8 ± 2.7
Reported change: −0.1 ± 0.6
Change from baseline at 4 months. A higher FSFI score indicates better sexual function.
P < 0.001Lubrication
FSFI domain score · bars show reported means on a 0–6 scale. Higher scores indicate better function in this domain.
P = 0.02RegenPRP™ group only (n = 30). ± values reproduced as reported in the brochure.
Satisfaction
FSFI domain score · bars show reported means on a 0–6 scale. Higher scores indicate better function in this domain.
P < 0.001RegenPRP™ group only (n = 30). ± values reproduced as reported in the brochure.
Pain
FSFI domain score · bars show reported means on a 0–6 scale. Higher pain-domain scores indicate less pain.
P < 0.001RegenPRP™ group only (n = 30). ± values reproduced as reported in the brochure.
FSFI score by improved domains
Baseline and 4-month follow-up · Saline vs RegenPRP™ · 30 women per group
Source: RegenPRP™ Therapy Gynaecology, p. 6; Hamid et al., BMC Women’s Health (2025), 25:576.
For healthcare professionals only
CONCLUSION
A single session of RegenPRP™ injections allows to alleviate symptoms of VVA and improves emotional wellbeing and social functioning of the patients.