Ghoniem 2009.

Methods	RCT, multicentre.
Participants	260 randomised, 247 studied, women with SUI primarily intrinsic sphincter deficiency, failed conservative treatments. Mean age 61 years. 24% had prior surgery.
Interventions	Macroplastique™ versus Contigen™. Repeat treatment allowed after 3 months.
Outcomes	Stamey grade, pad weight and IQOL score 12 months after surgery primary outcome measure. decrease in baseline IQOL of at least 1 Stamey grade at 12 months
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	High risk
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Patient blinded; physician unaware; unclear who completed assessment
Incomplete outcome data (attrition bias) All outcomes	Low risk	12 patients who withdrew and 1 patient wrongly treated were excluded from analysis. At 12 months 51 patients were considered as discontinued as lost to follow‐up.
Selective reporting (reporting bias)	Low risk