Efficacy and safety of non-ablative ErYAG laser for mild to moderate stress urinary incontinence: a prospective, multicenter, randomized, sham-controlled clinical trial.

This study evaluated the efficacy and safety of a non-ablative vaginal Er: YAG laser device in treating stress urinary incontinence (SUI). We conducted a prospective, multicenter, randomized, sham-controlled clinical trial in which women with SUI received either active treatment with Er: YAG laser therapy or sham control with a non-therapeutic handpiece. Patients underwent three treatments spaced one month apart. The primary endpoint measure was the treatment success rate at three months post-treatment. A total of 126 participants with SUI were recruited, with 84 in the active arm and 42 in the sham arm. One participant in the sham arm was excluded due to not using research instruments. The treatment success rate at three months post-treatment was 36.59% in the sham arm and 71.43% in the active arm, with an absolute difference of 34.84% (95% CI: 17.2-52.5%). Incontinence quality of life questionnaire (I-QOL) score and incontinence questionnaire short form (ICIQ-SF) score demonstrated significant improvement in the both arms with no substantial difference between the groups. Non-ablative vaginal ErYAG laser therapy demonstrated a significant improvement in objectively measured SUI symptoms compared to sham treatment. The non-ablative Er: YAG laser therapy seems to be a promising non-surgical treatment option for SUI patients. The limitations of this study are the short follow-up and limited sample size, so additional studies with longer follow-up and larger number of patients are needed to further elucidate the role of this therapy for SUI.