Ugurlucan 2013.

Methods	RCT of PELVILACE TO (biological TOT material) vs synthetic TOT material (ALIGN TO urethral support system)
Participants	100 women Inclusion criteria: women >18 years with SUI, MUI or USI in whom conservative treatment had failed. Women with or without POP were included Exclusion criteria: women with ISD Pre‐ and postoperative assessments included evaluation of urinalysis and urine culture POP evaluation using POP‐Q system, 1‐hr pad test, 4‐day bladder diary, stress test, Q‐tip test, and QoL assessment using the KHQ, UDI‐6, and the IIQ‐7. This was repeated at the 12‐month follow‐up. Postoperative urodynamics was performed in all patients accepting the procedure Mean age (years; SD): Group A: 55.0 (12.3); Group B: 52.9 (10.6) Mean BMI kg/m² (SD): Group A: 31.8 (6.6); Group B: 31.3 (4.8) Postmenopausal: Group A: 29 (56.9%); Group B: 30 (58.8%) Previous incontinence surgery: Group A: 2 (4%); Group B: 2 (4%) Concomitant POP surgery: Group A: 28/50; Group B: 28/50
Interventions	Group A: biological PELVILACE TO (n = 50) Group B: synthetic TOT ALIGN ®TO (n = 50)
Outcomes	Primary outcome: patient‐reported improvement in urinary incontinence (either completely dry or improvement in symptoms of SUI; reported as 'cure,' 'better than before,' 'no change at all,' and 'worse than before.') Secondary outcomes: objective cure: defined as the absence of SUI and a negative stress test at 200 ml in the standing position objective improvement: defined as improvement in the bladder diary and questionnaires Subjective evaluation by the patients was reported as “cure,” “better than before,” “no change at all,” and “worse than before.” intra‐ and postoperative complications reoperation rate Groin pain Vaginal tape erosion QoL: assessed via KHQ, P‐QoL, UDI‐6, and IIQ‐7
Notes	Biological tape was PELVILACE® TO system; Bard, Covington, GA, USA and the synthetic tape was ALIGN ®TO urethral support system; Bard TOT operation. The PELVILACE® TO system consists of a PELVICOL® self‐anchoring, natural tissue sling implant and an introducer system. This system contains a self‐anchoring, 1.5 cm wide, and 40 cm long suburethral sling of porcine dermal collagen. The ALIGN® TO urethral support system is a suburethral sling device made of type 1 monofilament polypropylene mesh designed for the treatment of SUI through the TOR Postmenopausal patients received local estrogen treatment for 1 month before and after the operation Concomitant POP was performed in a cohort of women
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: " In this prospective randomized study ... Randomization was carried out using computer‐generated random allocations prepared by an investigator with no clinical involvement in the trial"
Allocation concealment (selection bias)	Low risk	Quote: "computer‐generated random allocations prepared by an investigator with no clinical involvement in the trial"
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Quote: "The patients were blinded to the sling material used."
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "Follow‐up was performed ... by the same physician who was blinded to the type of sling used"
Incomplete outcome data (attrition bias) All outcomes	Low risk	All accounted for