Efficacy and safety of hyaluronate-based fillers in non-surgical pelvic floor correction
AbstractThe aim of the study was to evaluate the efficacy and safety of volumetric correction of the labia major and minor with hyaluronate-based fillers.
Material and methods. The study included 63 patients aged 36–49 years with a verified diagnosis of N81.8 «Pelvic floor muscle insufficiency» (with the condition of absence of muscle and fascia defects), L57.4 «Involutive changes of anogenital skin» and vaginal relaxation syndrome (hypotrophy of labia major and minor, perineal ptosis). Patients in the study cohort were stratified into two groups by blind randomization. 1st group (n=31): patients underwent moderate volumetric correction of the soft tissues of the vulva and the introital fossa with a high-molecular-weight sodium hyaluronate filler in the dosage of 21 mg/ml in 2 ml volume. 2nd group (n=32) had maximum volumetric correction of the vulval soft tissues with 21 mg/ml high-molecular sodium hyaluronate-based filler (DELIGHT® G, ADELAMI Medical Group, Israel) in 4 ml volume.
To assess the efficacy and safety of the therapy, standard perineological examination methods were used; the pH of the vaginal environment was measured; a comprehensive study of the vaginal microbiota was performed using Real-time PCR (Femoflor®-16, DNA-Technology, Russia); comparison of the frequency of nonspecific vulvovaginitis and dyspareunia severity (VAS) was made; PAIS (Patient’s Aesthetic Improvement Scale), GAIS (Global Aesthetic Improvement Scale) and FSFI (Female Sexual Function Index) questionnaires were used.
Study design: an open, independent, prospective, single-center comparative study was carried out.
Results. As a result of the volumetric correction in 80% of patients in the study cohort perineal architectonics was restored and the lost volume of the vulval soft tissues was replenished. The effect was maintained for 12 months in 71% of the patients in 1st group and 75% of patients in 2nd group (p>0.05). At the same time, all patients showed normalization of vaginal biocenosis with restoration of the degree of colonization of Lactobacillus spp. to 107, a decrease in the frequency of recurrence of nonspecific vaginitis by 4 times and the severity of dyspareunia by 5 times, and an improvement in the quality of sexual life (p>0.05).
Conclusion. In patients with a verified vaginal relaxation syndrome, injections of high-molecular-weight sodium hyaluronate-based filler at a dosage of 21 mg/ml (DELIGHT® G, ADELAMI Medical Group, Israel) in a minimum volume (2 ml) may be considered a more attractive option for volumetric correction. Moderate correction is not only not inferior in efficiency and safety in comparison with the maximum (4 ml) from a clinical point of view, but is also more cost-effective, and the overall aesthetic and functional effects are maintained for one year after manipulation. There were no complications both in the early postoperative period and during the follow-up for 12 months.
Keywords:pelvic floor weakness; vaginal relaxation syndrome; labia majora and minora; hypotrophy; hyaluronic acid; volumetric correction
Funding. The study had no sponsor support.
Conflict of interest. The authors declare no conflict of interest.
For citation: Orazov M.R., Radzinskiy V.E., Khamoshina M.B., Orekhov R.E. Efficacy and safety of hyaluronate-based fillers in non-surgical pelvic floor correction. Akusherstvo i ginekologiya: novosti, mneniya, obuchenie [Obstetrics and Gynecology: News, Opinions, Training]. 2023; 11. Supplement: 25–35. DOI: https://doi.org/10.33029/2303-9698-2023-11-suppl-25-35 (in Russian)
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