Porena 2007.

Methods	RCT of TVT versus TOT
Participants	145 women Inclusion criteria: women with stress or MUI (stress component clinically predominant) associated with urethral hypermobility (ICS definitions) Exclusion criteria: previous anti‐incontinence surgery and POP > stage 1, according to the Half‐Way system and POP‐Q system classification, in any vaginal compartment With the exception of DO, which was significantly more common in the TOT group, no significant intergroup differences emerged with regard to surgical histories, SUI grade, frequency of mixed incontinence, preoperative voiding or storage symptoms and preoperative urodynamic parameters VLPP determined at a bladder volume of 200 mL and participants performed several Valsalva manoeuvers with a gradual increase in abdominal pressure. Participants stratified by VLPP > 60 cm H2O or VLPP ≤ 60 cm H2O VLPP ≤ 60 cm H2O (ISD): Group A: 25/70; Group B: 25/75 Mean age (years; SD): Group A: 61.8 (10.7); Group B: 60.6 (10) Postmenopausal: Group A: 61/70; Group B: 64/75 SUI: Group A: 42/70; Group B: 41/75 MUI: Group A: 28/70; Group B: 34/75 DO: Group A: 4/70; Group B: 14/75
Interventions	Group A: TVT (n = 70) Group B: TOT (n = 75)
Outcomes	Primary outcomes: objective cure: participants were classified in 2 categories: 'dry' (no leakage during clinical examination and/or stress test and/or reported by participants) vs 'wet'. Wet participants were then sub‐divided into 'improved' (> 50% reduction in incontinence episodes) or 'failure' operating time intra‐ and postoperative complications including bladder injury, vaginal penetration and major vascular injury Secondary outcomes: postoperative lower urinary tract dysfunctions including voiding dysfunction subjective and objective changes in SUI tape erosion All participants completed 2 validated questionnaires on QoL, the UDI‐6 and the IIQ‐7 before surgery, at 3, 6, 12 months postoperatively and then annually Patient satisfaction outcome was measured via a VAS scale Objective cure (dry) Objective cure and improved (dry + wet but improved) Subjective cure (dry) Subjective cure and improved(dry + wet but improved) Bladder injury Vaginal perforation Major vascular injury Voiding Dysfunction Tape erosion Long‐term follow‐up (> 6 years, mean 99 ± 19 months): 83 participants (45 TOT; 38 TVT) underwent a telephone interview in October 2012.
Notes	TVTTM (Gynecare; Ethicon, Somerville, NJ, USA) TOTTM was a fusion‐welded, non woven, non knitted polypropylene tape (Obtapej; Mentor‐Porges, Le Plessis‐Robinson, France) All participants underwent a preoperative urodynamic assessment and intraoperative cystoscopy Follow‐up was at 3, 6, and 12 months postoperatively, and then annually Lower urinary tract dysfunctions and continence status were measured at each follow‐up visit by a blinded assessor The overall median follow‐up was 35 months
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "prospectively randomized by a predetermined computer‐generated randomization code, to the retropubic approach (TVT) or the transobturator route (TOT)"
Allocation concealment (selection bias)	Low risk	Quote: " Randomization was done using sealed, opaque, numbered envelopes, which contained the randomized allocation"
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	No information
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Outcome assessors were blinded
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote: "No patient was lost during follow‐up"