Chapter 3.2 44 PFMT: 61.5% (16/26); OR=1.06; 95% CI= 0.39-2.89; p=0.910). There were neither obvious differences in changes in other subjective outcome measurements (UDI-6 scores and sexual functioning (PISQ-IR)) (Table 2), nor was there any apparent inter-group difference in objective outcome (CST) from baseline to four months (Table 3). Figure 1: CONSORT flow diagram. Two participants discontinued their allocated treatment (one in each group). At 24-months follow-up 10 participants were lost to follow-up. Despite several attempts we were unable to contact these participants. At 24-months follow-up, 53.8% (14/26) of participants in the laser group and 58.3% (14/24) in the PFMT group sought additional yet alternative treatment. In the laser group 1/26 (3.8%) participants opted for a urethra pessary, 3/26 (11.5%) started with PFMT and 10/26 (38.5%) underwent surgery. In the PFMT group 3/24 (12.5%) opted for a pessary, 11/24 (45.8%) underwent surgery and none of them had repeated PFMT treatment. None of the participants in either groups requested additional laser treatment. In other words, only 46% (12/26) of patients in the laser group and 42% (10/24) in the PFMT group, did not seek additional treatment. Of those, 66.7% (8/12) and 80 % (8/10) reported feeling still better or much better (PGI >3). No serious adverse events were observed at any time point. Twenty-five percent of patients in the laser group (7/28) reported minor adverse events. The most frequent were vaginal bleeding, spotting or discharge, which were mild, and self-limiting. The participant‐reported degree of discomfort during laser manipulation was 28.62 ± 17.22. There were no obvious differences for scores during subsequent applications. Overall, the operator rated the degree of difficulty of treatment as ‘easy’ (median level=4).
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