A Systematic Review of Nonsurgical Vulvovaginal Restoration Devices: An Evidence-Based Examination of Safety and Efficacy

Abstract

Background: The efficacy and safety of vulvovaginal restoration devices were called into question in a U.S. Food and Drug Administration statement on July 30, 2018, claiming that women are being harmed by laser and other energy-based devices. The goal of this systematic literature review was to assess existing data, determine gaps in evidence, and propose opportunities for continued investigation pertaining to laser and energy-based vaginal restoration techniques. Methods: A review of literature using PubMed, Cochrane Library databases, Embase, MEDLINE, and the Cumulative Index to Nursing and Allied Health Literature was conducted on January 9, 2019, and articles up to this point were considered. For inclusion, studies had to be available or translated in English and relate to clinical medicine, direct patient care, and nonsurgical energy-based vulvovaginal procedures. Results: The authors found five level I studies, 19 level II studies, four level III studies, and 46 level IV studies that used 15 different devices. Various degrees of improvement of symptoms were reported in all studies. Adverse events/side effects were noted in two of the 13 radiofrequency device studies, 15 of the 23 erbium:yttrium-aluminum-garnet device studies, and 17 of the 37 carbon dioxide device studies. The majority of adverse events were considered mild. Conclusions: The majority of studies resulted in mild to no adverse side effects. However, there is a large gap in level I evidence. As a result, the authors emphasize the necessity of supplemental data surrounding this subject and suggest that additional randomized sham-controlled studies be conducted to further investigate vulvovaginal restoration devices in an effort to address women’s health issues.

The Role of Bipolar Radiofrequency (Bprf) as a Mechanism of Bio-Stimulation for the Treatment of Vulvo-Vaginal Laxity: A Novel Approach

“…Vaginal laxity increased in the patients included in the study by 2.20; the base score being 2.46, by identifying items as "slightly loose", "slightly tight", "neither loose nor tight" and "moderately tight" with a total percentage of 89.7%; which is similar to what Caruth (2018) referred to in his research [17], as well as by Lalji and Lozanova (2017) who reported 89% from "very loose" to "moderately tight" [18], by Sekiguchi et al with a statistically sig-nificant difference (<0.001) during 12 months, and finally by Millheiser et al (2010) with a total improvement of 87% [14]. This type of results is to be expected since radiofrequency favors collagen contraction, neocolagenesis, angiogenesis and infiltration of the growth factor that allows restoring the elasticity of the vaginal mucosa [24].…”

Microablative fractional radiofrequency as a therapeutic option for vulvar lichen sclerosus: a pilot study

“…The first pilot study on vaginal and vestibular MFR for genitourinary menopausal syndrome reported that the intervention was effective on atrophy symptoms, was well tolerated, and was associated with a rapid recovery; however, the study included only a few women (21). More robust studies have confirmed that MFR can be beneficial in the treatment of patients with genitourinary disorders (22,23). Sarmento et al (22) conducted a randomized trial on the effects of MFR on vaginal health, microbiota, and cellularity in postmenopausal women.…”

“…Laser and fractioned radiofrequency are used to improve general skin and mucosal trophism, especially in the vagina and vulvar vestibule. Several researchers have reported that these interventions produce clinical improvement, as well as promising results in neocollagenesis and neoelastinogenesis assessed using histopathology, electron microscopy, and immunohistochemistry (8,(18)(19)(20)(21)(22)(23)(24). According to Condi et al (25), dermal collagen can be assessed by measuring collagen I and II fractions, and neocollagenesis can be evaluated using picrosirius staining with polarized microscopy to highlight fiber width and orientation.…”

Carbon Dioxide Laser Vulvovaginal Rejuvenation: A Systematic Review

“…However, more randomized, sham-controlled trials are required. Furthermore, there is a large gap in level I evidence [75]. The number of sessions required has not been standardized because studies were performed in different populations and inclusion criteria varied significantly among the studies.…”

“…More research into the number of sessions required would help determine the cost-effectiveness of the procedure. Objective standards pertaining to time to orgasm, vulvovaginal appearance, vaginal laxity, vaginal lubrication, and changes that occur in the vaginal wall are also lacking [75]. Lastly, the improvement in clinical findings should be confirmed with histopathologic studies to provide more robust data [76].…”