The stress urinary incontinence (SUI) is one of the most common dysfunctions of the lower urinary tract, which affects a women’s quality of life. Measuring a women’s quality of life is very important to assess women’s perception of health. This is based on the interaction of physical, psychological, social, functional, emotional factors, mental well-being, as well as the status of work, environmental quality, vitality, pain, fear, and depression. The aim of this study was to measure the impact of the innovative pelvic floor muscle training (iPFMT) on the Quality Adjusted Life Years (QALYs) in women with stress urinary incontinence (SUI) treated by duloxetine.

This analysis is a part of the study conducted between February 2019 and 2020. The clinical trial was a randomized intervention, parallel, multicentre study at urological outpatient clinics at the national level for 12 weeks. Women were assigned in a 1:1 ratio to the experimental and control groups, using simple randomization according to odd and even numbers assigned sequentially to the patients at each clinic. An estimated 63 women were required for each group. 
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; 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 control group received oral duloxetine treatment (40 mg BID), the experimental group received oral duloxetine treatment (40 mg BID) and iPFMT with lumbopelvic stabilization. The iPFMT was performed 5 times a week for 20–30 minutes a day, in cooperation with a physiotherapist. 
The SUI was analyzed 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) (1). The calculation of the weighting factor (WF) was done by a linear transformation of the ICIQ-UI-SF (WF = 1 – ICIQ-UI-SF score/21). The QALYs gained were calculated by multiplying life expectancy (LE) by a weighting factor (QALYs = LE * WF). Statistical non-parametric tests were used for statistical analyses at a significance level of 0.05 using the IBM SPSS Statistics for Mac, version 25.0 (IBM Corp., Armonk, N.Y., USA).

The study included 158 women, of whom 129 women (81.6%) were fully analyzed in the control group (n = 64) and experimental group (n = 65). All women were Caucasians with a mean age of 55.2±13.0 years (range 29-80 years), body mass index of 27.6±4.9 kg/m2. The mean life expectancy for the control group was 26.3±11.8 years and for the experimental group 29.0±11.7 years. The mean baseline ICIQ-UI-SF score was in control vs an experimental group of 15.2±1.7 vs 15.1±1.5 and final ICIQ-UI-SF score of 9.8±4.2 vs 8.3±3.8 (p<0.05). The mean baseline weighting factor was in control vs an experimental group of 0.27±0.08 vs 0.28±0.07 and a final weighting factor of 0.53±0.20 vs 0.60±0.18 (p<0.05). Following 12 weeks of treatment, incremental QALYs in the control vs experimental group had increased as follows: 0.12±0.04 vs 0.14±0.04 (p<0.05). The mean baseline QALYs gained per year in control vs experimental group was 0.27±0.08 vs 0.28±0.07 and final QALYs 0.53±0.20 vs 0.60±0.18 (p<0.05). Before the treatment, the number of QALYs gained per life expectancy in control vs experimental group was 7.53±4.24 vs 8.30±4.01. The number of QALYs gained per life expectancy in control vs experimental group had increased following treatment: 15.03±9.63 vs 17.90±9.86 (p<0.05). The number of QALYs gained per life expectancy was increased in control vs experimental group by 99.7±71.1% vs 127.0±95.2% (p<0.05). The stress urinary incontinence evaluated with the ICIQ-UI-SF was decreased in control vs experimental group by 37.0±22.3% vs 45.0±23.3% (p<0.05).

The ICIQ-UI-SF confirmed statistically significant differences between women receiving duloxetine and women receiving combination treatment with duloxetine and iPFMT. The number of QALYs gained was approximately 100% higher following duloxetine treatment, but combined duloxetine with iPFMT achieved 30% more.

The combination treatment of duloxetine with iPFMT statistically significantly increased the number of QALYs and reduced the degree of urinary incontinence in women with stress urinary incontinence.

Neurourol Urodyn. 2004;23:322–30