Effect of radiofrequency and pelvic floor muscle training in the treatment of women with vaginal laxity: A study protocol

Background Vaginal laxity is an underreported condition that negatively affects women’s sexual function and their relationships. Evidence-based studies are needed to better understand this complaint and to discuss its treatment options. Thus, we present a study protocol to compare the effect of radiofrequency and pelvic floor muscle training in the treatment of women with complaints of vaginal laxity. Methods/Design This is a prospective, parallel-group, two-arm, randomized clinical trial (Registry: RBR-2zdvfp–REBEC). Participants will be randomly assigned to one of the two groups of intervention (Radiofrequency or Pelvic Floor Muscle Training). The study will be performed in the Urogynecology outpatient clinic and in the physiotherapy outpatient clinic at the State University of Campinas–UNICAMP and will include women aged ≥ 18 years and with self-reported complaints of vaginal laxity. Participants will be assessed at baseline (pre-intervention period) and will be followed up in two periods: first follow-up (30 days after intervention) and second follow-up (six months after intervention). Expected results The results of this randomized clinical trial will have a positive impact on the participants’ quality of life, as well as add value to the development of treatment options for women with complaints of vaginal laxity. Trial registration Registry: RBR-2zdvfp–Registro Brasileiro de Ensaios Clínicos–REBEC (19/02/2020).

The efficacy and safety of a combined multipolar radiofrequency with pulsed electromagnetic field technology for the treatment of vaginal laxity: a double-blinded, randomized, sham-controlled trial

Non-invasive vaginal rejuvenation with radiofrequency (RF) and lasers devices have gained popularity, but well-designed studies confirming their effectiveness are lacking. The aim of this study was to compare the efficacy and safety of a multipolar RF and pulsed electromagnetic field-based device (PEMF) versus sham for vaginal laxity. Thirty-two premenopausal females with ≥ 1 vaginal delivery and self-reported vaginal laxity were randomized into 2 groups: active (RF + PEMF) and sham. Both groups received 3 vaginal treatments at 3-week interval. The Vaginal Laxity Questionnaire (VLQ), perineometer measurements, and Brink score were conducted at baseline, 4, and 12 weeks after treatments. Pre and post-treatment vaginal histology, Female Sexual Function Index (FSFI), subjects’ satisfaction, pain, and adverse events were assessed. The active group VLQ scores increased and were significantly better than the sham group (p < 0.001). At the final follow-up, 50% of the active group reported no vaginal laxity (VLQ > 4) versus 12% in the sham group (p = 0.054). In the active group, all domains of perineometer measurements and Brink scores (p < 0.001), FSFI scores (p < 0.05), and patients’ satisfaction (p < 0.001) were significantly increased and higher in the active group. Mild adverse effects including pain and burning sensation were not different between groups except for itch which was significantly higher in the sham arm (p = 0.014). Histology after RF + PEMF treatments demonstrated neocollagenesis, neoelastogenesis, and neoangiogenesis. In conclusion, combination RF + PEMF therapy was safe, improved vaginal laxity, strengthened pelvic floor muscles, and improved female sexual function for at least 12-week post-procedures with confirmed histological improvements. This study was registered on the Thai Clinical Trials Registry, TCTR20200803002 on 2020–07-30 “retrospectively registered.”

Role of Elastin Expression in Thickening the Postpartum Vaginal Wall in Virgin and Postpartum Rat Models

Childbirth induces a number of alterations, including ligament weakening and increased vaginal distensibility. The occurrence of vaginal laxity or distensibility is associated with the vaginal wall and introitus overstretching during vaginal parturition while the pathophysiology is due to increased levator dimension and trauma to the levator ani muscle through avulsion (macrotrauma) or overdistension (microtrauma). Elastin is an extracellular matrix protein that confers elastic properties to organs and tissues, particularly those requiring elasticity. Elastin plays a vital role in the functioning of numerous tissues, such as the lungs, blood vessels, heart valves, ligaments, tendons, and skin. It is also a component of the vaginal mucosa. The aim of the present was to evaluate the role of elastin in the thickening of the postpartum vaginal wall composed of epithelial mucosa, and to understand the mechanism underlying vaginal laxity or distensibility within parous and nulliparous animal models. A total of 32 female white rats (Rattus norvegicus) were used in the present study. They were divided into two groups, each group consisting of 16 rats. The control group (C0) consisted of virgin nulliparous rats, which were sacrificed on the second day after vaginal parturition. Pregnant rats (group C1) were sacrificed on the second day after vaginal parturition. The median elastin expression in group C1 was higher (3 ± 0.56) than group C0 (2.85 ± 0.75). The mean thickness of the vaginal mucosal epithelium in group C0 (56,8 931µm) was greater than group C1 (44,98 349µm). The comparison of vaginal mucosal epithelium thickness between the two groups indicated a significant difference between groups C0 and C1. Elastin levels were significantly correlated with epithelial thickness. The expression of elastin significantly affects the vaginal wall thickness, which further affects vaginal laxity or vaginal distensibility.