CO2 Laser Therapy versus Urogynecology Physiotherapy in SUI : prospective randomized non inferiority study

Pelvic floor muscle training (PFMT) is considered the first-option as a conservative treatment for female stress urinary incontinence (SUI). However, there is still debate whether energy-based devices are effective for treating SUI.We aimed to assess whether PFMT and fractional CO2-laser may improve symptoms in SUI women. A parallel, randomized, non-blinded, non-inferiority trial included 94 of 144 women over 18 years of age with SUI into two groups. The CO2-laser group (n=47) received three vaginal applications at monthly intervals. The PFMT group (n=47) underwent two weekly sessions. Primary outcome was the mean-difference of International Continence Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) total-scores between groups after 3 and 6 months. Main secondary outcomes were questionnaires for assessment of pelvic floor symptoms (PFIQ-7), sexual function (FSFI), and improvement after treatment (PGI-I). A reduction in the ICIQ-SF total-score, PFIQ total-score and the UIQ score was perceived between baseline and 3-6 months in both groups. CO2-laser did not reach the non-inferiority margin when compared to PFMT in both follow-up periods and analyses. PGI-I assessment has shown an improvement in both groups.