Evaluation of the effect of multipoint intra-mucosal vaginal injection of a specific cross-linked hyaluronic acid for vulvovaginal atrophy: a prospective bi-centric pilot study.

BACKGROUND: Vulvo-vaginal atrophy (VVA) is one of the common consequences of estrogen deficiency especially after the menopause. Several studies have assessed the effects of Hyaluronic acid (HA) on physical and sexual symptoms associated with VVA with promising results. However, most of these studies have focused on subjective assessment of symptom response to topically administered preparations. Nonetheless, HA is an endogenous molecule and it is logical that its effects are best realized if injected in the superficial epithelial layers. Desirial® is the first crosslinked HA that is administered by injection in the vaginal mucosa. The aim of this study was to explore the effect of multipoint vaginal intra-mucosal injections of specific cross-linked hyaluronic acid (DESIRIAL®, Laboratoires VIVACY) on several clinical and patient reported core outcomes. METHODS: A cohort bi-centric pilot study. The chosen outcomes included change in vaginal mucosa thickness, biological markers for collagen formation, vaginal flora, vaginal pH, vaginal health index, vulvo-vaginal atrophy symptoms and sexual function 8 weeks post Desirial® injection. Patients' satisfaction was also assessed using the patient global impression of improvement (PGI-I) scale. RESULTS: A total of 20 participants were recruited between 19/06/2017 and 05/07/2018. At the end of the study, there was no difference in the median total thickness of the vaginal mucosa or in procollagen I, III or Ki67 fluorescence. However, there was a statistically significant increase in COL1A1 and COL3A1 gene expression (p = 0.0002 and p = 0.0010 respectively). There was also a significant reduction in reported dyspareunia, vaginal dryness, vulvar pruritus, vaginal chafing and significant improvement in all female sexual function index dimensions. Based on PGI-I, 19 patients (95%) reported varying degrees of improvement where, 4 (20%) felt slightly better; 7 (35%) better and 8 (40%) much better. CONCLUSIONS: Multi-point vaginal intra-mucosal injections, of Desirial® (a crosslinked HA) was significantly associated with the expression of CoL1A1 and CoL3A1 suggesting stimulation of collagen formation. Furthermore, there was a significant reduction in VVA symptomatology and a significant improvement in patient satisfaction and sexual function scores. However, there was no demonstrable change in the total vaginal mucosal thickness. Study registration ID-RCB: 2016-A00124-47, Protocol code number: LOCAL/2016/PM-001.

Female urine incontinence: vaginal erbium laser (VEL) effectiveness and safety.

Urinary incontinence is a common health problem that impacts the quality of life of women at different ages. Its physiopathology is not unequivocal, and it is necessary to consider the stress urinary incontinence (SUI), the overactive bladder syndrome and the mixed incontinence (MUI). According to the type of incontinence, its impact on the quality of life and age of the patients, therapeutic strategies are currently summarized in physiotherapy, surgery and drug treatments. We already know the benefit/risk ratio of each of these strategies. Our objective is to evaluate the potential effectiveness and safety of the VEL, an innovative vaginal laser technique (VEL - Vaginal Erbium Laser, erbium yttrium-aluminum-garnet -Er: YAG) a non-invasive laser proposed as a treatment for SUI, overactive bladder syndrome and MUI. The mechanisms of action of lasers are discussed in general and those of VEL in particular with the description of the Smooth® mode. To do this, we have collected the 21 published studies including the first randomized vs. placebo and two pilot studies of intra-urethral VEL. In conclusion: VEL procedures already have their place between the rehabilitation of the perineal floor and surgery. Further properly sized, randomized studies are needed to evaluate the laser treatments in comparison with other therapies, as well as to assess the duration of the therapeutic effects and the safety of repeated applications.

Genitourinary syndrome of menopause (GSM) and laser VEL: a review.

The purpose of this publication is to summarize the results of the vaginal erbium:yttrium-aluminum-garnet (Er:YAG) Smooth® laser (VEL) on the vaginal atrophy component of the genitourinary syndrome of menopause (GSM). GSM has two categories of clinical signs related to estrogen deficiency: symptoms of vulvovaginal atrophy (VVA) and urinary symptoms. This symptomatology is chronic, progressive over the years and affects a majority of women concerned by natural menopause but not exclusively: we must also consider the growing number of survivors of gynecological or non-gynecological cancers (breast, cervix, uterus, vagina, anus, etc.). At a time when hormonal treatment of menopause is contested as is the installation of under urethra prosthesis, the innovation provided by the VEL technology has the merit of offering the women concerned an effective therapeutic alternative with the security of a patent. The VEL technology has an original and unique process: acting only by thermal effect and not by ablation on tissue, VEL is a safe solution in terms of side effects and potential complications. Studies have been increasing since 2012 and all demonstrate a significant improvement in the GSM signs and symptoms, as well as an improved sexual life after VEL treatment. Double-blind, placebo-controlled, randomized studies are expected in order to ultimately confirm the safety and effectiveness of VEL.