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1. Introduction
The natural aging process can indeed lead to various physiological changes, and among the most commonly noticeable are alterations in the skin, which are easily visible.[1] As skin loses its characteristics, such as elasticity through loss of collagen, it results in wrinkles and fine lines. This may be attributed to both physiologic and external factors. Although some extrinsic factors may be modifiable, such as poor nutrition or ultraviolet rays, inherent factors such as hormonal or aging is inevitable.[2] However, with the development of diverse aesthetic procedures, there has been an increasing demand for these anti-aging processes by tightening the skin. Vulvar rejuvenation is meaningful as it addresses both aesthetic concerns and women’s sexual confidence, which is a crucial part of psychological well-being. Considering that the vulva is susceptible to external stimuli and stress, there is a need for safe and effective procedures that prioritize women’s health.[3]
Currently, one of the most commonly used equipment primarily utilizes radiofrequency (RF), where monopolar RF delivers heat into the epidermal skin layers to achieve skin tightening through stimulating collagen production.[4] However, recently developed method involves the utilization of high intensity focused ultrasound (HIFU), which is a non-invasive measure as it can reach deeper tissues without damaging the epidermis. HIFU can reach mid and deep reticular dermis, where it thermally denatures collagen leading to immediate tissue contraction, and initiating neocollagenesis.[5] Previous studies indicated that HIFU shows higher level of neocollagenesis and neoelastogenesis in the deep reticular dermis without causing damage to superficial tissue compared to RF.[6] Furthermore, in a comparative study, HIFU was found to induce more focal collagen production compared to RF, which delivers heat in a more diffuse way. This suggests that HIFU may offer more accurate and precise aesthetic procedures.[7]
As HIFU has emerged as a novel treatment for skin tightening and rejuvenation, primarily for the neck and face,[8] there have been attempts to identify its application as a non-surgical method of vaginoplasty. This approach aims to address conditions such as vaginal laxity and atrophy. Therefore, our study aims to describe the efficacy and safety of HIFU by comparing symptoms and patient satisfaction after HIFU procedure. By utilizing the data from our survey, it would be possible to assess the improvement of symptoms, which are the most prevalent in patients, and evaluate the efficacy of HIFU in clinical settings.
2. Methods
This is a single-center, before-after study conducted at the Honest women’s clinic (Seoul, South Korea). The data used in this study were approved by the Institutional Review Board of the Korea Biomedical research Institute (E-2023-000-01). This study was conducted in accordance with the principles of the Declaration of Helsinki and all participants signed a written informed consent form. The data were extracted from 15 females who had symptoms related to vulvovaginal laxity. A questionnaire asking about 10 symptoms related to vulvovaginal laxity was utilized to evaluate the subjective symptoms of patients both pre- and post-treatment. The scoring ranged from 1 to 5, where a score closer to 1 indicated a higher level of discomfort for each item using visual analogue scale score ranging from 0 to 5. The mean age of patients participating in this study was 41 years (95% CI, 36.90 to 45.63). Characteristics of participants before vulvovaginal laxity test are illustrated in Table 1. Additionally, 66.6% of patients had a history of delivery. Statistical analyses were performed using SAS (version 9.4; SAS Institute Inc., Cary, NC, USA).[9] The data are presented as mean with 95% confidence intervals (CIs). A two-sided p-values less than 0.05 were considered statistically significant.
3. Results
Before the procedure, the most common symptoms were dull tone, reduced elasticity, wrinkles, and loss of sexual confidence. Upon examining each symptom, except for dull tone, three symptoms showed notable improvement (Table 2). For elasticity, the score increased from 3.07 (95% CI, 2.49 to 3.64) before HIFU to 3.93 (95% CI, 3.49 to 4.38), while for wrinkles, there was an increase from 3.13 (95% CI, 2.63 to 3.64) to 3.73 (95% CI, 3.29 to 4.18), and sexual confidence improved from 2.33 (95% CI, 1.75 to 2.91) to 3.67 (95% CI, 3.13 to 4.21). A pie chart in Fig. 1 shows that 80% of patients reported no discomfort after the procedure, while 13.3% experienced stinging and itching, and 6.7% reported swelling.
4. Discussion
Recently, minimal invasive procedures have become widely utilized in cosmetic dermatology, gradually replacing traditional surgical interventions.[10] However, there is a limitation number of studies specifically examining improvements in subjective symptoms reported by patients and safety concerns following HIFU treatment in vulvar areas, particularly in Asian females. While some recent have suggested the effectiveness and safety of HIFU in vulvar areas, these studies primarily included Caucasian and Hispanic females,[11] who may have different skin types with Asian females. Our study also shows high patient satisfaction with the treatment, suggesting its efficacy in Asian females. Despite reports of some discomfort during the HIFU procedure, the symptoms subsided without the need for analgesics. Furthermore, the observed side effects were generally mild, including itching and swelling, with the majority of patients reporting no significant discomfort. It’s important to acknowledge the limitations of our study, such as the relatively small sample size and the short-term follow-up period.
In conclusion, HIFU treatment appears to be an effective and safe option for skin and subdermal tightening in the vulvar areas. This treatment may reduce wrinkles, improve tone and elasticity, and enhance sexual confidence. Given that symptoms of vulvar laxity may be associated with mental stress, self-confidence, and overall quality of life, HIFU treatment could offer significant benefits to females experiencing these concerns in a safe way. However, further studies with higher levels of clinical evidence are necessary to validate these results comprehensively.
