Evaluation of the safety and efficacy of a monopolar nonablative radiofrequency device for the improvement of vulvo‐vaginal laxity and urinary incontinence

Summary Background and objective Vaginal childbirth, natural process of aging, congenital factors, and surgical interventions are considered the main causes of vulvo‐vaginal laxity driven by changes in collagen and elastin fibers. This causes a loss of strength and flexibility within the vaginal wall. As a result, women may experience lack of sensation and stress urinary incontinence ( SUI )—the condition of involuntary loss of urine associated with activities that cause an increase in intra‐abdominal pressure (eg, sneezing, coughing, and lifting). Both vaginal laxity and urinary incontinence significantly affect patients' quality of life (QoL). The aim of this study was to evaluate efficacy and safety of a noninvasive radiofrequency device when used to treat SUI and vulvo‐vaginal laxity through its heating effect which stimulates collagen and elastin fibers. Methods Twenty‐seven women (average age 44.78±10.04 years) with indications of mild/moderate SUI as well as vulvo‐vaginal laxity were treated with a monopolar radiofrequency device. The treatment course consisted of three once‐a‐week sessions. Each session included intravaginal treatment followed by treatment of labia majora and the perineum. Improvement in the SUI condition was evaluated by applying the International Consultation on Incontinence Questionnaire ‐ Urinary Incontinence Short Form ( ICIQ ‐ UI SF ). Data were collected at the baseline, after the last treatment and at 1‐month follow‐up visit. Vaginal laxity was assessed by subjective vulvo‐vaginal laxity questionnaire ( VVLQ ). Data were collected before the 1st treatment and during the 1‐month follow‐up visit. Patient's satisfaction was recorded using a satisfaction questionnaire. Data were collected after the last treatment and at the 1‐month follow‐up visit. Any adverse events related to the treatments were monitored. Results On a scale of 0 to 5, the average frequency of urine leak improved from “2‐3 times a week” (2.15±1.03 points prior to treatment) to “ once a week” (1.00±0.78 points post‐treatment), and on to “ never” (0.44±0.51 points at the 1‐month follow‐up visit). Sixteen subjects (59.3%) reported decrease in the amount of leakage, with 15 women (55.6%) becoming completely leak‐free at the 1‐month follow‐up. At the 1‐month follow‐up visit, 24 subjects (88.9%) expressed their condition's interference with everyday life decreased and 17 patients (62.9%) said the condition did not interfere with their everyday life at all as a result of the treatment. All results are statistically significant ( P <.05). No adverse events were recorded. All subjects reported improvement in vaginal laxity, from average perception of “ very loose” (2.19±1.08 points prior to treatment) to “ moderately tight” (5.74±0.76 points at the 1‐month follow‐up visit). During the follow‐up visit, 89% of the patients “ agreed” or “ strongly agreed” that their SUI condition improved, and 93% of the patients “ agreed” or “ strongly agreed” that their gratification during intercourse improved. None of the subjects reported dissatisfaction. Conclusion The study confirmed the monopolar radiofrequency method as an effective and safe treatment of SUI and vulvo‐vaginal laxity. The treatments were well tolerated by all subjects with no adverse effects.