Andrada Hamer 2012 SEC.

Methods	Prospective randomised multi‐centre study comparing TVT versus TVT‐Secur
Participants	123 women with primary SUI or MUI with predominant SUI Inclusion criteria: age > 18 years; desires surgical treatment; does not desire future pregnancy; >= 3 mL leakage on standardised pad test; cough‐synchronous leakage on cough stress test Exclusion criteria: need for concomitant surgery for pelvic organ prolapse; regular PFMT for less than 3 months; planned or current pregnancy; previous surgery for urinary incontinence, bladder capacity < 300 mL; residual urinary volume > 100 mL; known detrusor instability; cystitis more than 4 times in the past 12 months
Interventions	TVT (62) TVT‐Secur (61)
Outcomes	Pad test, stress test, KHQ, voiding diary, visual analogue scale
Notes	2011 paper follow‐up at 2 months, but this is a full article. The 2012 paper is an abstract but reports 1‐year outcomes Subjective cure rate assessed but method of interpretation not defined. Study stopped at interim analysis because of poor outcomes and high rate of serious complications with TVT‐S 133 participants randomly assigned. Loss to follow‐up in 2 patients. 4 women were excluded because of protocol violations, and 4 declined surgery for personal reasons after they had been randomly assigned. Intention‐to‐treat analysis not done or reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "Consenting women who fulfilled all inclusion criteria were randomised in a proportion of 1:1"
Allocation concealment (selection bias)	Low risk	Quote: "an equal proportion of assignments were mixed and placed in opaque envelopes which were then sealed, mixed again and numbered and kept at a central study secretariat"
Incomplete outcome data (attrition bias) All outcomes	High risk	133 participants randomly assigned. Loss to follow‐up in 2 patients. 4 women were excluded because of protocol violations, and 4 declined the surgery for personal reasons after they had been randomly assigned. Intention‐to‐treat analysis not done or reported
Blinding of participants and personnel (performance bias) All outcomes	High risk	Surgeon and participant blinding not possible because of the nature of the procedure
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "the follow up was performed by an independent evaluator, usually a urotherapist"