A Novel Technique Combining Human Acellular Dermal Matrix (HADM) and Enriched Platelet Therapy (EPT) for the Treatment of Vaginal Laxity: A Single-Arm, Observational Study

Abstract

Abstract Background There is a paucity of knowledge about cosmetic vaginal tightening procedures; therefore, the present study aimed to describe the clinical effects of a novel combination technique of human acellular dermal matrix (HADM) and enriched platelet therapy (EPT) for the treatment of vaginal laxity. Methods This single-arm, observational study was conducted on 52 patients with grade II to III vaginal relaxation. HADM biological band (U-shaped) was implanted in these patients by submucosal puncture in vagina under anesthesia. This was followed by thrice administration of EPT injection, once at the time surgery followed by each dose at a time interval of one month. Patients were followed up for a period of 6 months based on Female Sexual Function Index (FSFI) and Vaginal Health Index (VHI) scores. Patient satisfaction was measured using Visual Analogue Score (VAS). Results About 52 women with median age of 39 years were included in the study. The average time reported to complete HADM surgery was reported as 27 minutes. Following implantation, it was found that labia minora was significantly closed and perineal length was increased from 1.5 to 2.2 cm. Moreover, there was improvement in elasticity, contractility and lubricity of vaginal mucosa. The sexual function scores from pre- to post-surgery were significantly increased (7.95 vs. 30.09; p value: <0.001). The mean VHI score also increased significantly after 6 months of treatment (mean ± S.D. before vs after treatment: 11.2 ± 3.3 vs. 19.6 ± 4.1, P < 0.0001). The mean VAS after surgery was 1.61 ± 0.31. About 96% of the patients did not feel any pain after treatment at 6-month follow-up. No adverse effects were reported in this study. Conclusions These findings supported that combination treatment with HADM and EPT was safe and associated with both improved vaginal laxity and sexual function. These results may provide a novel surgical technique for this prevalent and undertreated condition. Level of Evidence IV : Therapeutic Study This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.