eTable 3. Current key studies on the surgical treatment of stress urinary incontinence in women.
n | Comparison | Study design | Primary endpoint | Results [95% CI] | Adverse events |
Study: Schellart et al. (2014) (e23) | |||||
193 | MiniArc vs. TOT | randomized, non-blinded, non-inferiority design | Improved PGI-I score | MiniArc is not inferior to TOT after 3 years | 13% serious adverse events with MiniArc, 11% with TOT |
Study: Itkonen Freitas et al. (2022) (e24) | |||||
223 | TVT vs. polyacrylamide hydrogel (bulkamide) |
randomized, non-blinded, non-inferiority design | patient satisfaction questionnaire | bulkamide is inferior to TVT at 3 years* | 43.5% complication rate for DVT, 24% for bulkamide* |
Study: Dogan et al. (2018) (e25) | |||||
201 | needle-free single-incision muscular sling (SIMS) vs. TOT | randomized, non-blinded, single-center | negative cough test | SIMS and TOT are comparably effective at 2 years (90% vs. 85% cure) | 13% complication rate with TOT, 7% with SIMS* (SIMS significantly fewer symptoms) |
Study: Holdø et al. (2017) (e26) | |||||
307 | Burch colposuspension vs. TVT | non-randomized, non-simultaneous case series comparison | recurrent incontinence | revision rates at 12 years, 11% (colposuspension) vs. 2% (TVT)* |
16% complication rate with colposuspension vs. 11% with TVT |
Study: Lau et al. (2013) (e27) | |||||
100 | TOT vs. TOT after vaginal prolapse net (Prolift) | non-randomized, prospective case series comparison | negative cough test | at 3–6 months, 86% cure rate for TOT versus 62% for TOT after vaginal mesh* | 9% complication rate with TOT after vaginal mesh vs. 0% with TOT* |
Study: Ward KL (2008) (e28) | |||||
344 | Burch colposuspension vs. TVT | prospectively randomized, non-blinded multicenter trial | negative 1 hour pad test | at 5 years, 81% cure rate for colposuspension vs. 90% for TVT | more recto- and enteroceles with colposuspension*, complication rate 11% with colposuspension vs. 8% with TVT |
Study: Karmakar (2017) (e29) | |||||
341 | transobturator tape, inside-out vs. outside-in | postal follow-up of a randomized, controlled trial | patient satisfaction, measured with the PGI-I | 71.6 % satisfaction and 14% improvement | in 7.96% new urinary incontinence surgery required, 4.5% erosion rate, 4.32% pain, in 1.4% therapy required |
Study: Dejene et al. (2022) (e30) | |||||
334 601 | follow-up of up to 15 years | cohort study | Frequency of of surgical revisions | at 10 years, 6.9%; at 15 years, 7.9% increased risk of surgical revision, in women aged 18–29 vs. ≥ 70 years |
approx. 50 % of surgical revisions necessitated by tape erosion |
PGI-I, Patient Global Impression Incontinence; TOT, transobturator tape; TVT, tension-free vaginal tape“ (retropubic);
*p ≤ 0.05