Background: Stress urinary incontinence (SUI) has a huge impact on the quality of life (QoL) in women and its treatment is challenging. Intraurethral laser may be an additional treatment option.~Study aim: The aim is to study the effectiveness of intraurethral laser therapy in women with SUI.~Design: randomized double blinded sham - controlled clinical study~Study population: women which have been diagnosed with SUI I-II°, aged between 18-80 years.~Study groups: Participants will be randomized (1:1), without stratification. The Intervention group will receive 2 treatments of intraurethral laser therapy and the Control group will receive 2 treatments of intraurethral SHAM laser therapy.~Sample size: A sample size of 20 women, 8 per group including a 20% Drop Out Rate, was calculated.~Primary outcome: impact of SUI on the VAS scale 3 months after laser therapy versus sham laser therapy.~Secondary study outcomes were defined as subjective SUI, objective SUI, QoL, treatment satisfaction, intraurethral microbiome, 3 months after laser therapy versus sham laser therapy.
Primary aim of the study is to compare the impact of SUI on the VAS (visual analogue scale) 3 months after laser therapy versus sham laser therapy.