Chapter 3.1 32 In the laser group, 65.2%(15/23) of participants rated the PGI at 4 months as ‘better or much better’ compared to 60.9%(14/23) in the PFE group. A proportional odds model did not show any trend towards increased PGI scores in one group over the other (OR=1.12; 95% CI=0.39-3.23; p=0.833). There were no obvious differences in changes in other subjective outcome measurements (Table 2), nor was there any apparent inter-group difference in the objective outcome (Table 3). Six months after the last treatment, 43.5%(10/23) of participants in the laser group and 39.1%(9/23) in the PFE group sought additional yet alternative treatment: in the laser group 7/23(30.4%) participants opted for a pessary, 1/23(4.3%) began PFE and 2/23(8.7%) underwent surgery, whereas in the PFE group 8/23(34.8%) chose a pessary, 1/23(4.3%) underwent surgery and 2/23(8.7%) received repeated PFE treatment. Twenty-four months after the last treatment, 50% (11/22) of participants in the laser group and 57%(12/21) in the PFE group did not seek additional treatment. Of those, 63.6%(7/11) of the laser, and 75%(9/12) of the PFE-group reported feeling better or much better (PGI >3). No serious adverse events were observed at any time point. Minor complications were confined to the laser group (7/23) and included vaginal bleeding, spotting or discharge, that were mild and self-limiting. The participant‐reported degree of discomfort during laser manipulation was 21.72±17.58mm. There were no apparent differences between subsequent applications. Overall, the operator rated the degree of difficulty of treatment as ‘easy’ (median level=4). Table 1: Demographic characteristics of the study participants at baseline according to treatment group. Laser group (n=23) PFE group (n=23) All participants (n=46) Age (years) 62.00 ± 9.11 60.00 ± 12.04 61.00 ± 10.61 BMIa 23.65 ± 3.97 24.53 ± 3.24 24.09 ± 3.61 Parity 2.65 ± 1.15 2.26 ± 0.96 2.46 ± 1.07 Menopause 21/23 (91.3%) 16/23 (69.6%) 37/46 (80.4%) Smoking 3/23 (13%) 0/23 (0%) 3/46 (6.5%) Previous hysterectomy 3/23 (13%) 0/23 (0%) 3/46 (6.5%) aBMI: Body Mass Index. Data are mean ± SD or n/N (%) as appropriate.
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