Krofta 2010.

Methods	RCT of TVT vs TVT‐O
Participants	300 women Inclusion criteria: women with SUI after failed conservative treatment. All confirmed on a positive stress test (cough provocation). Women with symptoms of MUI were included if SUI was the predominant symptom Exclusion criteria: DO; previous incontinence, POP surgery, or pelvic radiotherapy; POP‐Q ≥ stage 2; PVR > 100 ml; preoperative use of anticholinergics; need for concomitant surgery Cough provocation test, multichannel UDS, urethral pressure profilometry and uroflometry were done preoperatively and at 12‐month follow‐up
Interventions	Group A: TVTTM (n = 149) Group B: TVT –OTM (n = 151)
Outcomes	Objective cure (negative stress cough provocation test with 300 ml of saline in the bladder during UDS and 1‐hour pad test weight < 5g) Subjective cure (self‐reported absence of SUI) Subjective improvement (women’s perception of urine loss less than the presurgical loss) De novo urge/urgency urinary incontinence Duration of operation Mean blood loss Haematoma Groin/suprapubic pain Tape erosion/extrusion Quality of life: ICIQ UI‐ SF and CONTILIFE questionnaires used Sexual dysfunction: assessed using PISQ‐12
Notes	All women with TVT had intraoperative cystoscopy but this was not performed in those with TVT‐O Loss to follow‐up: Group A: 8/141; Group B: 4/147
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "women were prospectively, randomly assigned to the study. We used the method of block randomisation with a random‐number generator"
Allocation concealment (selection bias)	Unclear risk	No information
Blinding of participants and personnel (performance bias) All outcomes	High risk	Quote: "The current randomised, non‐blinded study"
Blinding of outcome assessment (detection bias) All outcomes	Low risk	All participants were evaluated at follow‐up by 3 urogynaecologists, blinded to the different procedures
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote: "In the TVT group, 141/149 patients returned for a 1‐year follow‐up (dropout rate of 5.3%), and in the TVT‐O group, 147/151 patients were present for the 1‐year follow‐up (dropout rate of 2.6%)"