Paper Title
THE IMPACT OF AGING ON THE PATIENT GLOBAL IMPRESSION OF IMPROVEMENT IN WOMEN WITH STRESS URINARY INCONTINENCE TREATED WITH DULOXETINE AND PELVIC FLOOR MUSCLE TRAINING

Abstract
Aims of Study: The aging has a negative impact on pelvic floor muscles. To prevent lower urinary tract dysfunctions, in aging women, it is important to use conservative treatment. There are currently few studies on the effects of pelvic floor muscle training and duloxetine in aging women. The aim of this study was to measure the impact of aging on the Patient Global Impression of Improvement (PGI-I) in women with stress urinary incontinence (SUI) treated with duloxetine and pelvic floor muscle training. Study Design and Methods: This sub-analysis is a part of the clinical trial realized between February 2019 and 2020. It was a randomized intervention, parallel, multicentre study at urological outpatient clinics for 12 weeks. Adult women with uncomplicated SUI, who experienced at least seven urinary incontinence episodes per week, were included in the clinical trial. Women were assigned in a 1:1 ratio to the experimental and control groups, an estimated 63 women were required for each group. The control group received oral duloxetine treatment (40 mg BID), the experimental group received oral duloxetine treatment (40 mg BID) and pelvic floor muscle training with lumbopelvic stabilization (iPFMT). The iPFMT was performed 5 times a week for 20–30 minutes a day, in cooperation with a physiotherapist. The SUI was analysed during a baseline and a final period according to the International Consultation on Incontinence Questionnaire - Urinary Incontinence - Short Form (ICIQ-UI SF) with the range from 0 (without SUI) to 21 (the most severe SUI).The Patient Global Impression of Improvement (PGI-I) score evaluated the status of urinary incontinence at the end of the study compared to the condition before each patient started treatment in the study. It is a seven-point scale instrument of patient reported outcome measures (1 – very much better, 2 – much better, 3 – a little better, 4 – no change, 5 – a little worse, 6 – much worse, 7 – very much worse).The data were presented as mean values and standard deviations (SD), p values were obtained using a t test with ANOVA. The significance level was set at p<0.05. Results: The number of women who completed clinical study was 129 out of 158 (81.6%). Based on the sub-analysis, women were divided into four groups according to median age of 55 years and current treatment.The first group was treated with duloxetine and had an age below 55 years (n=32), the second group was treated with duloxetine and had an age above 55 years (n=32), the third group was treated with duloxetine and iPFMT and had an age below 55 years (n=36), the fourth group was treated with duloxetine and iPFMT and had an age above 55 years (n=29).There were no significant differences between all groups (ascending order of groups) before the intervention in the ICIQ-UI SF total score of 14.9 (SD 1.3) vs. 15.4 (SD 1.9) vs. 14.9 (SD 1.5) vs. 15.1 (SD 1.4); (p=0.572) but statistically significant changes following treatment with score of 8.3 (SD 3.5) vs. 11.1 (SD 4.3) vs. 7.5 (SD 3.7) vs. 9.4 (SD 3.8);(p=0.001). The incontinence episode frequency per week (IEF) were not significantly different before treatment, mean IEF of 22.3 (SD 16.8) vs. 29.9 (SD 20.7) vs. 20.6 (SD 13.7) vs. 23.4 (SD 13.6);(p=0.121). Relative percentual IEF changes were significant in all groups but most significant in the first and the third groups following the current treatment, mean change of -49.4 (SD 36.8) vs.-29.6 (SD 36.0) vs. -58.6 (SD 34.6) vs. -40.7 (SD 32.2);(p=0.008).Younger women achieved the best subjective improvement in the PGI-I score, but all groups achieved a statistically significant improvement after the current treatment(mean PGI-I of 2.2 [95% CI: 1.7-2.7] vs. 3.4 [95% CI: 3.0-3.8] vs. 1.8 [95% CI: 1.5-2.0] vs. 2.0 [95% CI: 1.7-2.4]). When comparing the percentage of any improvement in PGI-I compared to the current group of patients, younger patients had the best subjective improvement (69% vs.63 % vs.100 % vs. 67 %). Conclusion: The Patient Global Impression of Improvement (PGI-I) score revealed that younger women with stress urinary incontinence (SUI) treated with duloxetine and innovative pelvic floor muscle training had better subjective improvement than older women, with no difference in current treatment. Keywords - Stress Urinary Incontinence, Duloxetine, Aging, Physiotherapy, Pharmacology