The overweight has a negative impact on pelvic floor muscles. To prevent lower urinary tract dysfunctions, in overweight women, it is important to reduce overweight through regular physical exercise. There are currently few studies on the effects of pelvic floor muscle training and duloxetine in persistently overweight women. The aim of this study was to measure the effect of overweight on the Patient Global Impression of Improvement (PGI-I) in women with stress urinary incontinence (SUI) treated with duloxetine and pelvic floor muscle training.

This 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. 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. Inclusion criteria: woman over 18 years old who provided written informed consent; experienced uncomplicated SUI; experienced symptoms of urinary incontinence for at least three consecutive months immediately prior to the study; scored 14 points or more on ICIQ-UI SF; experienced at least seven urinary incontinence episodes per week (IEF); exhibited a degree of pelvic organ prolapse equal to stage 2 or less; expressed willingness to accept the randomization process and fully participate in tests. Exclusion criteria: a woman who is pregnant, lactating or actively trying to become pregnant; use of any pharmacologic agent to treat symptoms of urinary incontinence in the past 6 months; the history of anti-incontinence surgery in the past 12 months; use of onabotulinumtoxinA for the treatment of urinary incontinence in the past 12 months; the history of pelvic prolapse repair or urethral surgery in the past 12 months; the history of PFMT in the past 12 months; the history of interstitial cystitis or bladder-related pain; the history of chronic severe constipation; the history of clinically significant renal or hepatic impairment; the history of clinically significant heart impairment; non-compliance with limitation of duloxetine treatment for mixed urinary incontinence; current positive urinary tract infection; use of rehabilitation aids; use of antidepressant(s); insufficient understanding of iPFMT and/or omitting iPFMT; participation in any clinical study in the past 6 months. 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). Overweight was assessed by body mass index (BMI) as the ratio of weight to square height of the woman, it was defined as having BMI between 25 and 29.9 kg/m2. 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.

The number of women who completed clinical study was 129 out of 158 (81.6%). By sub-analysis, women were divided into four groups according to a calculated mean BMI of 27 kg/m2 and a current treatment. The first group was treated with duloxetine and had a BMI below 27 (n=34), the second group was treated with duloxetine and had a BMI above 27 (n=35), the third group was treated with duloxetine and iPFMT and had a BMI below 27 (n=30), the fourth group was treated with duloxetine and iPFMT and had a BMI above 27 (n=30). 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 1.1) vs. 15.1 (SD 1.7) vs. 15.5 (SD 2.1) vs. 14.9 (SD 1.1); (ANOVA, p=0.468) but statistically significant changes following treatment with score of 8.9 (SD 3.5) vs. 8.8 (SD 4.1) vs. 10.6 (SD 4.7) vs. 7.8 (SD 3.4); (p=0.046). The incontinence episode frequency per week (IEF) were not significantly different before treatment, mean IEF of 23.4 (SD 16.9) vs. 22.0 (SD 13.7) vs. 23.1 (SD 11.2) vs. 21.7 (SD 13.7); (p=0.277). Relative percentual IEF changes were significant in all groups but most significant in the second and the fourth groups following the current treatment, mean change of -40.5 (SD 41.3) vs. -59.5 (SD 30.3) vs. -38.4 (SD 33.2) vs. -49.9 (SD 36.8); (p=0.014). Overweight 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 3.3 [95% CI: 2.8-3.8] vs. 1.8 [95% CI: 1.6-2.1] vs. 3.3 [95% CI: 2.8-3.8] vs. 1.9 [95% CI: 1.6-2.2]). When comparing the percentage of any improvement in PGI-I compared to the current group of patients, overweight patients had the best subjective improvement (62% vs. 97 % vs. 70 % vs. 93 %).

The Patient Global Impression of Improvement (PGI-I) score revealed very interesting results because overweight women with a BMI over 27 had better subjective improvement than women with a lower BMI with no difference in current treatment. This group of overweight women achieved the best PGI-I score, as 97% of women with duloxetine and 93% of women with combination treatment subjectively improved.

Being overweight with a higher BMI increases the likelihood of a significant subjective improvement in women with stress urinary incontinence treated with duloxetine or duloxetine combination therapy with iPFMT.

Continence 2S2 (2022) 100476
DOI: 10.1016/j.cont.2022.100476