CO 2 Laser and radiofrequency compared to a sham control group in treatment of stress urinary incontinence (LARF study arm 3). A randomized controlled trial

Introduction and hypothesis Female stress urinary incontinence (SUI) is a prevalent condition, and conservative treatment options are needed. Were evaluated CO 2 laser and radiofrequency as treatment for SUI. Methods One hundred thirty-nine women with SUI were eligible and randomized in a three-arm double-blind randomized controlled trial into radiofrequency (RF), laser (LS) and sham control (SCT) groups, with 3-monthly outpatient treatment sessions. One hundred fourteen women were included, 38 in each group, during a 12-month follow-up. The primary outcomes were: subjective improvement of SUI, evaluated on a Likert scale, and objective cure, which was a composite outcome defined according to negative stress tests, voiding diary and pad test. Questionnaires were also applied. The sample size was calculated to provide 80% power to identify a 20% difference between groups, p < 0.05. Results Subjective improvement and objective cure of SUI were identified respectively in 72.6% and 45.2% in LS and in 61.7% and 44.7% in RF, both significantly higher than the 30.0% and 14.0% in SCT. Considering only mild cases (pad test < 10 g), objective cure was achieved in 66.7% in LS, 63.6% in RF and 22.2% in SCT. Significant reduction in the number of episodes of urinary incontinence was found according to voiding diaries ( p = 0.029) and pad weight ( p = 0.021). A significant reduction in urgency and urinary loss during sexual intercourse was observed only with LS and RF. Improvement in quality of life was also verified by the I-QoL and ICIQ-SF in favor of the energy-treated groups. Conclusions CO 2 laser and radiofrequency are outpatient options for SUI treatment, with no major complications. They had similar results and presented better results than in the sham control group.