VELSUI 43 not inferior to PFMT with respect to 4-month UDI-6 score, resulted in 28 patients per arm, or 56 in total. The calculation assumed a 11-point non-inferiority margin, equal mean UDI-6 scores in both treatment arms, and a SD of 30.92,94 Because of additional and higher than expected dropout rates early in the study, mainly due to a new peak in infections and subsequent restrictions in the Covid pandemic, we added an additional block of four patients, hence increasing the sample size from 56 to 60, without unblinding of the data. Superiority analyses tested differences between treatment arms on secondary outcomes. Change versus baseline was calculated for CST scores, the PISQ-IR score and UDI-6 score, using a linear model. The analysis of PGI used a logistic regression model for ordinal data, presenting results as odds ratio (OR). Longitudinal evolutions were estimated using linear mixed models with a random intercept to deal with repeated measures. Continuous variables are reported as mean (Standard deviation (SD)) or median (interquartile ranges (IQR)) and categorical variables as frequencies with percentages. RESULTS Sixty women were randomised between November 20, 2020 and March 21, 2022 (Figure 1). The baseline characteristics of participants are displayed in Table 1. In the laser group, one participant discontinued treatment due to lower abdominal pain and high blood pressure following the first application. In the PFMT group one participant discontinued her PFMT treatment, because she felt she could no longer comply with all the required follow-up visits and tests. Data from an additional 4 participants were missing for the primary outcome assessment at 4 months (1 in the laser group and 3 in the PFMT group). In the laser group, the mean number of treatment visits was 4.25 (SD 1.17). Only 32.1% (9/28) had 3 applications because they were either subjectively cured (n=2) or did not experience any improvement at all (n=7). The others requested additional applications, i.e. 4 (35.7% (10/28)), 5 (7.1% (2/28) or even 6 (7/28 (25%)) applications. In the PFMT group, 3 participants (11.5% (3/26)) requested an additional series of 9 supervised PFMT sessions, resulting in a mean number of treatment visits of 10.04 (SD 6.36). At 24-months follow-up 10 participants were lost to follow-up despite several attempts to contact them (4 in the laser group and 6 in the PFMT group). The mean difference in change of UDI-6 scores between laser and PFMT at 4 months was 6.34 (97.5% upper CI: 9.15) demonstrating non-inferiority of laser compared to PFMT (p=0.023) (Table 2). Based on UDI-6 scores, most patients tended to improve, yet subjective cure was reached only in a minority (laser: 10.7% (3/28); PFMT: 7.7% (2/26)). Again, in both groups most patients reported improvement based on a ‘better or much better’ Global Impression of Improvementscore, yet without apparent difference between treatment groups (laser: 67.9% (19/28);
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