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. 2023 Feb 3;120(5):71–80. doi: 10.3238/arztebl.m2022.0406

eTable 2. Current key studies on the pharmacotherapy of urinary incontinence in women.

n Comparison Study design Primary endpoint Results [95% CI] Adverse events
Study: Chapple et al. (2013) (e18)
928 mirabegron 25, 50, 100, 200 mg
vs. placebo
vs. tolterodin (ER) 4 mg
RCT
single-/double-blinded, placebo-controlled
reduction of urinary frequency/24 hr [- 1,9; – 2,1] ; [2,1; – 2,2]
vs. 1.4
vs. 2.0*
increased heart rate with mirabegron 100 (1.3%) and 200 (3%) mg vs. placebo (0.6%) vs. tolterodine (1.2%)
Study: Wagg et al. (2017) (e19)
4040 fesoterodine 4 or 8 mg vs. placebo RCT, double-blinded, placebo-controlled reduction of urinary incontinence episodes and urinary frequency/24 hr – 1.1 vs. – 0.5*
– 2.4 vs. – 1.5*
dose reduction because of side effects: fesoterodine 4 mg 3%, 8 mg 1%, placebo 1%
Study: Nitti et al. (2013) (e20)
557 botulinum toxin 100 U vs. placebo at 12 weeks RCT
double-blinded, placebo-controlled, multicenter phase 3 trial
reduction of the number of incontinence episodes per day – 2.65 vs. – 0.87*

complete continence 22.9 % vs. 6.5%
uncomplicated urinary tract infection 15.5 % vs. 5.9 %intermittent self-catheterization 6.1 % vs. 0 %
Study: Sand et al. (2017) (e21)
261 desmopressin 25 μg vs. placebo randomized, double-blinded, multicenter, placebo-controlled reduction of nocturia – 1.46 vs. 1.24* none
Study: Mirzaei et al. (2021) (e22)
60 solifenacin (10 mg) vs. duloxetin (20 mg) RCT, single-blinded questionnaire (ICIQ-OAB) from 14.86 to 9.66*
vs. from 13.90 to 8.76*
no difference between groups
side effects:
dry mouth, lack of appetite 33.3% and 20%
vs. 26.7% and 16.7%*

CI, confidence interval; ICIQ-OAB, International Consultation on Incontinence Questionnaire – Overactive bladder; RCT, randomized controlled trial; *p ≤ 0.05