Tcherniakovsky 2009

Methods	RCT. Follow‐up 12 months
Participants	41 women randomly distributed into two groups. Participants had similar baseline characteristics (age, BMI, parity, vaginal births, postmenopausal conditions, hormone replacement therapy, previous SUI surgery, genital prolapse, previous surgery/previous hysterectomy, disease duration) Inclusion criteria: USI, confirmed through medical history, physical exam, and urodynamic investigation
Interventions	A (20): retropubic sling B (21): SAFYRE TOT
Outcomes	Cure was reported absence of SUI and no urinary loss during effort manoeuvres at 12‐month follow‐up re‐evaluation. Failure at 12 months: A: 1/20, B: 2/21 Operative time (mean (SD)): A: 59.7 (10.3), B: 12.8 (2.4) mins Time to catheter removal: A: 2, B: 1 ds Complications: all complications: A: 12/20, B: 3/21; UTI: A: 2/20 B: 0/21; bladder perforation: A: 1/20, B: 0/21; urinary retention: B: 3/20, A: 2/21; vaginal mesh erosion (isolated): A: 0/20, B: 1/21
Notes	Physical exam specifically evaluated urinary loss through Valsalva manoeuvre and presence of other concurrent dystopias of pelvic floor (anterior, posterior, and apical), using POP‐Q classification. VLPP standardised in this study at 200 mL of vesical repletion Urodynamic study performed on every participant included
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Participants "randomly distributed". No detail provided
Allocation concealment (selection bias)	Unclear risk	Not mentioned
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Not mentioned
Incomplete outcome data (attrition bias) All outcomes	Low risk	No missing outcome data