Vaginal CO2 laser treatment for urinary stress incontinence: A randomized controlled trial.

OBJECTIVES

The effect of laser treatment for stress urinary incontinence is inconclusive. The aim of this study was to determine the efficacy and safety of vaginal CO2 laser in women with stress urinary incontinence.

STUDY

DESIGN

Single-site, patient-blinded, placebo-controlled randomized trial at Hvidovre University Hospital, Denmark. Thirty-seven women with mild to severe symptoms of stress urinary incontinence were included. They were randomized to either laser or sham treatment and received three treatments, four weeks apart. At first and last visit, the women completed the ICIQ-UI SF questionnaire and had a standardized urinary stress test. Both groups received supervised pelvic floor muscle training, and postmenopausal women were recommended vaginal estrogen treatment.

MAIN OUTCOME MEASURES: The primary outcome was post-treatment score on the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF). Scores were compared using Student's t-test and 95 % confidence intervals (CI). The secondary outcome was performance on the post-treatment standardized stress test.

RESULTS

Baseline characteristics did not differ between the groups. There was no difference in ICIQ-IU SF scores post-treatment between the two groups: mean score for the laser group 12.2 vs. 12.7 for sham (mean difference 95 % CI: -2.15 to 3.15; p-value 0.70). Likewise, we found no difference between the groups in performance on the post-treatment standardized stress test (95 % CI: -4.33 g to 40.73 g; p-value 0.11). One adverse event occurred, a bladder infection that required hospital admission.

CONCLUSIONS

In this study, CO2 vaginal laser did not improve the symptoms of stress urinary incontinence. It is acknowledged that the study population was small.

CLINICALTRIALS: gov (NCT04136652).