Radiofrequency-Based Devices for Female Genito-Urinary Indications: Position Statements From the European Society of Sexual Medicine

Abstract

Introduction Radiofrequency (RF)-based treatment has been introduced as an esthetic alternative treatment for various medical indications without the scientific backup of a satisfactory body of evidence. Furthermore, the United States Food and Drug Administration issued a warning regarding the safety of energy-based technologies for indications such as vaginal “rejuvenation," cosmetic vaginal treatment, vaginal conditions related to menopause, and symptoms of urinary incontinence and sexual function on July 30, 2018. Aim To perform a thorough review of the existing literature regarding RF-based vaginal devices for the treatment of female genitourinary indications and summarize the evidence available in a few short statements. Methods A thorough review of the literature regarding RF treatments for gynecological indications was performed based on several databases. Studies that included at least 15 patients were eligible for analysis. Main Outcome Measure Efficacy of RF devices for different genitourinary indications. Results Although a high level of heterogeneity of studies poses a serious challenge, the committee reached a decision on several statements related to the use of RF-based devices for genitourinary indications. Clinical Implications RF-based vaginal treatments have not been studied thoroughly enough in order to establish decisive recommendations regarding their safety and efficacy. Strength & Limitations These position statements have been established by a group of experts. The lack of strong evidence makes it difficult to give decisive recommendations. Conclusions Further randomized controlled trials with proper methodology and design are required to establish both benefits and possible harm these treatments may have in both short and long term for all the different indications studied.

Intravaginal Non-Ablative Radiofrequency In The Treatment Of Genitourinary Syndrome Of Menopausesymptoms: A Phase I Clinical Trial

“…The promising results stimulated our group to carry out an RCT of RF in the treatment of signs and symptoms of GSM that is in progress. This type of study is encouraged by the European Society of Sexual Medicine (35) . Using the non-ablative RF technique, Lordelo et al (2016) carried out a randomized clinical trial with 43 women dissatis ed with the appearance of their genitalia.…”

Office Procedures in Cosmetic Gynaecology

“…Types of RF devices are monopolar, unipolar, bipolar, multipolar [27]. These devices have been proposed for symptomatic treatment of GSM, SUI, and vaginal atrophy [28]. Focused electromagnetic…”

Nonablative, Noncoagulative Multipolar Radiofrequency and Pulsed Electromagnetic Field Treatment Improves Vaginal Laxity and Sexual Function

“…1,2 Further compounding this health issue is the lack of a uniformly accepted definition of VL, or genitopelvic laxity, since it is commonly considered a patient-reported condition deficient in standardization for diagnosis and severity grading that is based on expert consensus or scientific data. 3 Pelvic floor and vaginal trauma after pregnancy and vaginal childbirth, including stretching of the vaginal introitus, may cause permanent changes, resulting in loss in sexual sensation during intercourse and diminished sexual quality of life. 4,5 Potential medical consequences associated with vaginal childbirth, including VL, extend beyond the postpartum period and may include stress urinary incontinence, bowel incontinence, pelvic organ prolapse, dyspareunia, and chronic pelvic pain .…”

“…14 Preliminary data offered by energy-based devices are promising with respect to treatment efficacy of genitopelvic or VL; however, a large disparity does exist between treatment protocols and procedures, making the results difficult for interpretation and determination of consistent effects. 3 While a range of treatment options exist for VL, their effects on, and in association with, female sexual dysfunction (FSD) are only now starting to be more embodied in the medical literature. 2,15,16 While there are no specific recommendations regarding the role of RF-based vaginal devices in treating VL, shortterm improvements in VL and sexual function have been shown with laser and RF treatments, in which trends in temporary tissue architectural remodeling and integrity, combined with changes in sexual behavior, have been demonstrated.…”

“…2,15,16 While there are no specific recommendations regarding the role of RF-based vaginal devices in treating VL, shortterm improvements in VL and sexual function have been shown with laser and RF treatments, in which trends in temporary tissue architectural remodeling and integrity, combined with changes in sexual behavior, have been demonstrated. 2,3,11,16 These objective and subjective parameters established through laxity intervention have been shown to also exhibit shortterm improvements related to sexual function.…”