Silva Filho 2006

Methods	RCT of SAFYRE TOT with autologous pubovaginal sling. Randomisation method unclear.  Follow‐up 6 months
Participants	20 women (average age of 52.5 years ± 11.8 years) with both USI and SUI but without detrusor overactivity The 2 groups had similar characteristics with respect to age, parity, BMI, menopausal status, presence of pelvic floor defects, and mean Valsalva leak point pressure in the preoperative UDS
Interventions	A (10): pubovaginal sling B (10): SAFYRE TOT
Outcomes	Cure rates and intraoperative and postoperative morbidity. Women were declared objectively cured when they had a postoperative pad test of ≤ 8 g All participants were preoperatively evaluated by history, physical examination, QoL questionnaire (King's Health Questionnaire), a 24‐h pad weight test, a 2‐d voiding diary, and a multichannel urodynamic study that included uroflowmetry, post‐void residual volume measurement by urethral catheter, and a cystometrogram. The objective quantification of the severity of incontinence was done by the mean stress leaking point pressure in the urodynamic study. Preoperative measurements included the type of anaesthesia, duration of surgery, intraoperative complications, occurrence of combined procedures, and hospital stay. At 6‐month follow‐up the aforementioned measurements were carried out excluding UDS. Post operative pad test (mean (SD)): A: 8.4 (16.44), B: 39.4 (39.53) g; P = 0.01 Operative time (mean (SD)): A: 69.5 (23.7), B: 21.1 (3.8) min; P < 0.001 Length of hospital stay (mean (SD)): A: 44.4 (5.8), B: 28.8 (8.4) h; P < 0.001
Notes	SAFYRE consists of a monofilament polypropylene mesh between two silicone columns that are made of multiple cone‐shaped soft tissue anchors. The two columns are fixed to the obturator muscle. The pubovaginal sling uses rectus fascia
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not mentioned
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