VELPOP 31 RESULTS Forty-six women were randomised between November 20, 2020 and February 22, 2022 (Figure 1). All participants completed all treatment sessions. In the laser group, 30.4%(7/23) had the three planned applications either due to being subjectively cured (n=3) or experiencing no improvement at all (n=4). Remaining participants requested four (26.1%(6/23)), five (13%(3/23)) or six (7/23(30.4%)) applications. In the PFE group, two participants (8.7%) requested nine additional supervised PFE sessions. There were no missing data for the primary endpoint. By 24 months, three patients were lost to follow-up (1 in the laser, 2 in the PFE group). Figure 1: CONSORT flow diagram. There were no missing data points for any outcomes at the 4 months follow-up visit. At 24-months follow-up 3 participants were lost to follow-up. Despite several attempts we were unable to contact these participants. Baseline characteristics of participants were comparable between groups and are presented in Table 1. The mean difference in POPDI-6 scores between laser and PFE at 4 months was 1.09 (95% CI: (-6.02;8.20)) indicating non-inferiority of laser compared to PFE (p=0.004). The mean POPDI-6 scores compared to baseline tended to be lower in both groups: for laser, POPDI-6 scores decreased from 23.91±14.61 to 19.20±12.55 (-19.6%) and in PFE participants from 26.09±13.66 to 18.12±11.35 (-30.5%). Success, defined as a at least 25% reduction in score was reached in 11/23 participants (47.8%) in both groups.
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