Jakimiuk 2012.

Methods	RCT comparing TVT and TVT‐O: POLTOS study
Participants	Multicentre RCT in Poland 35 women Inclusion criteria: women with urodynamically proven (bladder filled to a minimum of 300 ml) SUI; no prior incontinence surgery Exclusion criteria: women with UTI; BMI > 33 kg/m²; previous hysterectomy; neurological incontinence; POP; PVR > 150 ml; OAB and MUI Age: 40‐80 years
Interventions	Group A: TVT (n = 19) Group B: TVT‐O (n = 16)
Outcomes	Subjective cure: self‐reported Objective cure: negative cough test and pad test Bladder perforation Voiding dysfunction Vascular injury Mean procedure time Mean hospital stay QoL: used non‐validated KHQ and validated SF‐36 questionnaires.
Notes	Follow‐up at 6 months Cystoscopy was performed in both groups Lost to follow‐up: Group A: 4/19; Group B: 0/16 (3 participants with bladder perforation had the tape removed and were excluded)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: “The randomisation was done through a web page secured with a 128‐bit code”
Allocation concealment (selection bias)	Unclear risk	No information
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: “every patient had extra skin incisions for masking the type of procedure (“sham operation”). Each patient had 4 skin incisions in localization typical for needle introduced in TVT and TVT‐O procedure”
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No information
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Information not clear