Study design, materials and methods
All women with stress urinary incontinence, who requested CO2 vaginal laser procedure, were prospective enrolled in this study. Only one CO2 vaginal laser procedure was performed for each enrolled participant. Patients received follow-up outpatient or telephone surveys at 3 and 6 months after the procedure, and then were received followed-up survey every 6 months thereafter. Patients also received pad testing at baseline, 3 and 6 months after the CO2 vaginal laser procedure. Those women who complained of no effect during the survey, were defined to be a lack of subjective improvement after the CO2 vaginal laser procedure. The subjective improvement interval was calculated from the date of the CO2 vaginal laser procedure to the date of the presence of no effect complaint, the date of the second CO2 vaginal laser procedure, the date of mid-urethral sling procedure, or the date of the last follow-up survey. An objective cure was defined by the observation of a pad weight of ≤1 g after the 1-hour pad test at 6 months after the CO2 vaginal laser procedure, and improvement was indicated by a >50% decrease in the pad weight at 6 months after the CO2 vaginal laser procedure compared with the preoperative data. Objective failure was defined by a ≤50% decrease in pad weight relative to the preoperative data at the 6-month follow-up. Stata software was used for statistical analysis. P <0.05 was considered as statistically significant.
Results
Between October 2018 and December 2021, a total of 75 women with stress urinary incontinence underwent CO2 vaginal laser procedure. Baseline data were shown in Table 1. The mean follow-up interval was 10.8±7.2 months (Table 1). Twenty-three women complained of no effect during the follow-up survey. The subjective improvement rates were 84% (95 confidence interval = 0.74 to 0.91) at 3 months, 81% (95 confidence interval = 0.70 to 0.89) at 6 months, 76% (95 confidence interval = 0.63 to 0.84) at 12 months, and 71% (95 confidence interval = 0.58 to 0.81) at 18 months, respectively (Figure 1A).
Only higher pad weight had a trend to be a predictor of lack of subjective improvement (hazard ratio = 1.005, 95 % confidence interval = 0.999 to 1.011, p=0.08) by univariate Cox proportional hazards model. Age and parity were not predictors.
There was a statistical difference in pad weight between baseline and 3/6 months (Skillings-Mack test, p=0.0056, Figure 1B). Further post hoc analysis revealed that there was a statistical significance between baseline and follow-up pad weights (p=0.0001 for 3 months and p=0.0036 for 6 months, respectively, Table 1). However, there was no difference between 3 and 6 months (p=0.27).
Based on pad testing at baseline and 6 months, the objective cure rate was 21 %, and the objective improvement rate was 42 %. Thus, the total successful rate was 63 % (Table 1).
Interpretation of results
The subjective improvement rate at 18 months was about 70 %, and the 6-month objective successful rate was about 60% after one CO2 vaginal laser procedure. Pad test was not a good test for predicting the subjective efficacy.