The aim of this study was to assess the efficacy of combined treatment with duloxetine and innovative pelvic floor muscle training (iPFMT) in an experimental group compared to duloxetine treatment in a control group in women with stress urinary incontinence (SUI), over 12 weeks of treatment. Outcome measures were change in incontinence episode frequency (IEF), incontinence quality of life (I-QoL), patient global impression of improvement (PGI-I).

This study was conducted between February 2019 and 2020. This study was a randomized intervention, parallel, multicentre study at urological outpatient clinics at the national level. Patients 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. We used power analysis to determine  appropriate sample size; the test strength was set at 0.80 and alpha was set at 0.05 (type I error). An estimated 63 probands were required for each group (experimental and control). We expected a decrease in the incidence of SUI after intervention from 10 to 35%. A decrease of more than 50% would be considered a success. 
	Incontinence episode frequency (IEF) was recorded for a period of one week. Urine leakage symptoms were reported according to the International Consultation on Incontinence Questionnaire –Urinary Incontinence - Short Form (ICIQ-UI-SF). Change in quality of life was reported according to the Incontinence Quality of Life Scale (I-QoL). The Patient Global Impression of Improvement (PGI-I) score evaluated the status of urination problems at the end of the study compared to the condition before each patient started treatment in the study. The control group received the same oral duloxetine treatment (40 mg BID) but did not perform iPFMT. The experimental group received oral treatment with duloxetine (40 mg BID) and iPFMT with stabilizing exercises. iPFMT were performed 5 times a week for 20–30 minutes a day, in cooperation with a physiotherapist. Probands were educated about anatomy, physiology and pelvic floor muscle functions, training pelvic floor muscles in different positions and training pelvic floor muscles with lumbopelvic stabilization. 
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 number of enrolled women was initially 158. Twenty-nine (18.3%) did not complete the study. Fourteen women (8.9 %) did not complete the study for duloxetine adverse events in the control group. Eight women (5.1 %) did not complete the study for the adverse effects of duloxetine, and six women (3.8 %) did not complete the study for low adherence to iPFMT in the experimental group.
       The final sample consisted of 64 women, mean age of (56.8 ± 13.8) in the control group and 65 mean age of (53.4 ± 11.9) women in the experimental group. There were no significant differences between the experimental and control groups before the intervention. The statistically significant differences in favor of the experimental group (p < 0.001) were confirmed in the number of IEF, ICIQ-UI-SF total score, PGI-I scale and I-QoL scores following 12 weeks of study (Table 1).

Other authors compared, in randomized controlled trials, the effects of duloxetine alone, standard pelvic floor muscle training (PFMT) alone, combined treatment (duloxetine and PFMT) and no active treatment in a women with SUI. The data support significant efficacy of combined standard PFMT and duloxetine in the treatment of woman with SUI (1).  The combined treatment of SUI with duloxetine and iPFMT achieved a more significant reduction in SUI than reported by previous authors for standard PFMT (Table 2).

The addition of iPFMT in the duloxetine-treated patient population significantly improves SUI compared to duloxetine alone.

J Urol. 2005; 173(5):1647-53.