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