Paparella 2010.

Methods	RCT of synthetic UretexTO® vs biological PelviLaceTO® outside‐inside TOT
Participants	Inclusion criteria: women with SUI and USI; SUI with urethro‐vesical junction hypermobility without ISD Exclusion criteria: POP > stage 1; previous urogynaecological or anti‐incontinence surgery; concurrent diseases such as psychiatric disease, diabetes, peripheral vascular disease; history of pelvic radiation; urge and mixed incontinence; DO; urgency or neurologic bladder; maximum urethral closure pressure < 20 cm H2O and VLPP < 60 cm H2O (indicators of intrinsic sphincter deficiency); maximum flow ≤ 12 ml/s; and PVR volume ≥ 100 ml Mean age (years; SD): Group A: 60.7 (7.1); Group B: 59.4 (8.4) Mean BMI kg/m² (SD): Group A: 25.4 (1.8); Group B: 24.9 (1.8) Menopausal: Group A: 26/34; Group B: 30/36 (participants in menopause were subjected to at least 1 month of local hormone replacement therapy both before and after the surgery) QoL and sexual impact measured via: KHQ and PISQ‐12
Interventions	Group A: synthetic UretexTO® (n = 34) Group B: biological PelviLaceTO® (n‐36)
Outcomes	Objective cure of incontinence was defined as the absence of SUI, with a negative cough stress test; objective improvement as the improvement of SUI, with a positive cough stress test at a higher bladder filling than in the preoperative test; in all other cases it was considered a failure. Subjective cure rates were self‐evaluated by the participants as 'very satisfied', 'satisfied', or 'not satisfied'. Mean operating time Mean length of hospital stay days Perioperative complications Major vascular injury Voiding dysfunction Tape erosion QoL: assessed with KHQ PISQ‐12 scores pre‐operatively and at 2 years follow up.
Notes	Group A: synthetic (UretexTO®; Bard, Covington, GA) is self‐anchoring transobturator suburethral sling (1.2 cm wide and 45 cm long) made of the same monofilament polypropylene fibres used in many modern tension‐free sling devices (for example TVT, TVT‐O, TOT Monarc, TOT ARIS etc). Polypropylene is a very biocompatible material that has been used for many years in the construction of medical‐grade synthetic meshes. The important difference is how the polypropylene fibres are knitted to form a cohesive macroporous mesh Group B: biological material (PelviLaceTO®; Bard, Covington, GA) is a tension‐free and self‐anchoring transobturator suburethral sling (1.5 cm wide and 40 cm long). It consists of a porcine dermal collagen implant that is intended to provide a matrix for the incorporation of new tissue, cells and blood vessels, thanks to a natural porosity and artificial V‐shaped holes along the arms. Its collagen matrix consists of 3 amino acid chains arranged in a triple helix that has been cross‐linked with hexamethylenediisocyanate to improve durability making the collagen non‐resorbable by the collagenase (enzymes produced by inflammatory cells and fibroblasts that increase during surgery). It is also described as an acellular and deproteinised material so it should not cause an immune response Follow‐up evaluation was carried out after 6 weeks, 6 months, 1, and 2 years 2‐year follow‐up: Group A: 16.6 (3.0); Group B: 17.2 (3.0) Loss to follow‐up: Group A: 1/34; Group B: 0/36
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: “Randomization was done using sealed opaque envelopes containing computer‐generated random allocations in a ratio of 2:2 in balanced blocks of 4”
Allocation concealment (selection bias)	Low risk	Quote: “Randomization was done using sealed opaque envelopes containing computer‐generated random allocations in a ratio of 2:2 in balanced blocks of 4”
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	No information
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: “Follow‐up evaluation was carried out after 6 weeks, 6 months, 1, and 2 years (and/or earlier if problems were experienced) for all patients by two independent physicians”
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote: “All patients in both arms completed the follow‐up (2 years)”