The Effectiveness of Adding Transvaginal Radiofrequency to Pelvic Floor Muscle Training for 6 Weeks in Women with Stress Urinary Incontinence. A Double-Blind Randomised Controlled Trial.

INTRODUCTION AND HYPOTHESIS: The objective was to evaluate the clinically beneficial effect of adding transvaginal monopolar non-ablative radiofrequency (RF) to pelvic floor muscle training (PFMT) on leakage severity, quality of life and urinary incontinence-related symptoms in women with stress urinary incontinence (SUI).

METHODS

A double-blind randomised controlled trial was conducted, with a 6-week intervention and a 6-month follow-up. Participants were randomly assigned to the experimental group (PFMT plus RF; n = 18) or the control group (PFMT plus placebo; n = 20). The primary outcome was the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF). Secondary outcomes included the Pelvic Floor Distress Inventory-20 (PFDI-20) and the Pelvic Floor Impact Questionnaire-7 (PFIQ-7), self-efficacy, female sexual function, pelvic floor muscle dynamometry, 1-h pad test and number of SUI episodes per week. Inferential analyses of the data were performed using a two-factor analysis of variance.

RESULTS

Both groups achieved a statistically significant improvement in ICIQ-SF over time. However, the differences observed in the experimental group exceeded the minimal clinically important differences by 4 points (MD = -9.4, 95% CI = -12.6 to -6.3), which was not observed in the control group (MD = -3.9, 95% CI = -6.9 to -1.0). This was maintained at the 6-month follow-up with a significant time*group interaction (p < 0.001, ηp2 = 0.150). There was no time*group interaction in the other variables (p > 0.05). Additionally, a significant difference in favour of the experimental group was observed in the 1-h pad test and episodes of SUI per week (p < 0.05).

CONCLUSIONS

This study highlights the beneficial effects of adding transvaginal RF to PFMT on the severity and amount of leakage, as well as on the quality of life and urinary incontinence-related symptoms in women with moderate SUI. Future trials are needed to assess the effects of this intervention in women with severe SUI.