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

ABSTRACT: Objective: This study investigated nonablative/noncoagulative multipolar radiofrequency and pulsed electromagnetic field (RF/PEMF) treatment for vaginal laxity (VL) and its impact on sexual function in parous women. Methods: This prospective, open-label single-center study enrolled 34 female subjects, 23-59 years of age, with ≥1 vaginal delivery and self-reported VL. Three monthly intravaginal treatments with RF/PEMF energy were performed. Treatment and follow-up assessments included the vaginal health index (VHI), vaginal pH, female sexual function index (FSFI), and VL/sexual satisfaction (SS) and subject satisfaction scores. Mean score and percent improvement over baseline were reported. Subject discomfort/pain was assessed after each treatment. Results: Total and each individual domain scores of the VHI improved significantly, while vaginal pH levels decreased from baseline to both 1 and 4 months (p < 0.01) after the last treatment. FSFI (<0.001), VL (<0.001), and SS (<0.001), including overall satisfaction scores (<0.01), improved post-treatment, with positive effects further sustained until at least 4 months post-treatment. Pain/discomfort post-treatment was reported as none to mild. No noticeable adverse events (AEs) or unanticipated side effects were reported. Conclusions: Nonablative/noncoagulative multipolar RF/PEMF is safe and is associated with significant 1- and 4-month post-treatment improvements in symptoms associated with VL and sexual dysfunction, as assessed by the VHI, vaginal pH, FSFI, and VL subject satisfaction score. SS and overall satisfaction scores also improved. The treatment was well tolerated with no or little pain, and no adverse events were reported. Clinical Trial Registration number: NCT04607798.

SUBMITTER: Kolodchenko Y

PROVIDER: S-EPMC8317596 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:OBJECTIVE:This subanalysis of the VIVEVE I trial aimed to evaluate the impact of cryogen-cooled monopolar radiofrequency (CMRF) therapy, for the treatment of vaginal laxity, on the domains of sexual function included in the Female Sexual Function Index (FSFI). MATERIALS AND METHODS:The VIVEVE I clinical trial was prospective, randomized, single-blind, and Sham-controlled. Nine clinical study centers in Canada, Italy, Spain, and Japan were included. This subanalysis included premenopausal women with self-reported vaginal laxity who had ?1 term vaginal delivery and a baseline FSFI total score ?26.5, indicating sexual dysfunction. Enrolled subjects were randomized (2:1) to receive CMRF therapy [Active (90?J/cm2) vs. Sham (?1?J/cm2)] delivered to the vaginal tissue. Independent analyses were conducted for each FSFI domain to evaluate both the mean change, as well as the clinically important change for Active- versus Sham-treated subjects at 6 months post-intervention. RESULTS:Subjects randomized to Active treatment (n?=?73) had greater improvement than Sham subjects (n?=?35) on all FSFI domains of sexual function at 6 months postintervention. The analysis of covariance change from baseline analyses showed statistically significant improvements, in favor of Active treatment, for sexual arousal (p?=?0.004), lubrication (p?=?0.04), and orgasm (p?=?0.007). In addition, Active treatment was associated with clinically important and statistically significant improvements in sexual desire [Odds ratio (OR)?=?3.01 (1.11-8.17)], arousal [OR?=?2.73 (1.06-7.04)], and orgasm [OR?=?2.58 (1.08-6.18)]. CONCLUSIONS:This subanalysis showed CMRF therapy is associated with statistically significant and clinically important improvements in sexual function in women with vaginal laxity. These findings provide the first randomized, placebo-controlled energy-based device evidence for functional improvements associated with a nonsurgical modality for a highly prevalent and undertreated condition.

Project description:BackgroundVaginal laxity (VL) is characterized by the relaxing of the vaginal wall that affects the quality of life and sexual function of patients. The current management of VL such as Kegel exercises and topical or systemic hormonal replacement results in unsatisfactory outcomes; thus, novel modalities are needed to improve the efficacy. Vaginal fractional carbon dioxide (CO2) laser treatment has shown growing applications for the treatment of VL, but results show nonconformities due to the lack of objective evaluations. In this study, we aimed to validate the clinical efficacy and biophysical benefits of fractional CO2 laser treatment for VL patients with the incorporation of objective approaches.MethodsThis is a descriptive study without controls. A total of 29 patients were enrolled and treated with two sessions of FemTouch vaginal fractional CO2 laser, with a one-month interval between sessions. Both subjective and objective measurements, including female sexual function index (FSFI), vaginal health index score (VHIS), vaginal tactile imaging (VTI), and histology were used to validate the clinical efficacy and biophysical benefits after treatment.ResultsThe overall FSFI scores and VHIS scores after the first and second treatment sessions were significantly higher than the baseline scores (p < 0.01, n = 29). VTI measurements showed a significant increase in maximal pressure resistance (kPa) of both the anterior and posterior vaginal walls at a 10-12-month post-treatment visit compared with pre-treatment controls (p < 0.001; n = 16). Histological examination showed that laser treatment led to increases in the thickness of the stratified squamous epithelium layer and density of connective tissues in the lamina propria.ConclusionsFractional CO2 vaginal laser treatment can improve both vaginal health and sexual function and restore vaginal biomechanical properties by increasing vaginal tissue tightening and improving vaginal tissue integrity in Asian women. Our data support that fractional CO2 vaginal laser is a valid treatment modality for VL.

Project description:Some studies have shown that people living near a mobile phone base station may report sleep disturbances and discomfort. Using a rat model, we have previously shown that chronic exposure to a low-intensity radiofrequency electromagnetic field (RF-EMF) was associated with paradoxical sleep (PS) fragmentation and greater vasomotor tone in the tail. Here, we sought to establish whether sleep disturbances might result from the disturbance of thermoregulatory processes by a RF-EMF. We recorded thermal preference and sleep stage distribution in 18 young male Wistar rats. Nine animals were exposed to a low-intensity RF-EMF (900 MHz, 1 V x m(-1)) for five weeks and nine served as non-exposed controls. Thermal preference was assessed in an experimental chamber comprising three interconnected compartments, in which the air temperatures (Ta) were set to 24°C, 28°C and 31°C. Sleep and tail skin temperature were also recorded. Our results indicated that relative to control group, exposure to RF-EMF at 31°C was associated with a significantly lower tail skin temperature (-1.6°C) which confirmed previous data. During the light period, the exposed group preferred to sleep at Ta?=?31°C and the controls preferred Ta?=?28°C. The mean sleep duration in exposed group was significantly greater (by 15.5%) than in control group (due in turn to a significantly greater amount of slow wave sleep (SWS, +14.6%). Similarly, frequency of SWS was greater in exposed group (by 4.9 episodes.h-1). The PS did not differ significantly between the two groups. During the dark period, there were no significant intergroup differences. We conclude that RF-EMF exposure induced a shift in thermal preference towards higher temperatures. The shift in preferred temperature might result from a cold thermal sensation. The change in sleep stage distribution may involve signals from thermoreceptors in the skin. Modulation of SWS may be a protective adaptation in response to RF-EMF exposure.

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

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