Sharifiaghdas 2008

Methods	RCT of TVT with autologous rectus fascia sling. Randomisation by sealed, opaque envelopes. Follow‐up 1, 3, 6 and 12 months
Participants	100 women randomised into 2 groups. However only 61 followed up to 1 year. 16 were lost due to distance and expense of travel, 12 were age‐related and 11 because  of dissatisfaction with surgical result (6‐Sling, 5‐TVT) Inclusion criteria: history of USI, 1‐h pad‐test (> 2 g of leakage), objective positive cough (effort or exertion) ? induced stress test, normal cystourethroscopy and urodynamic confirmation of SI, urethral hypermobility and competent bladder neck Exclusion criteria: history of > 3 episodes of UTI in past 2 years, other gynaecological problems such as high grade uterine prolapse, high grade rectocele and enterocele, cystocele ≥ grade 2, abnormal filling phase of urodynamic study, low flow rates (< 15 mL/s), residual urine of more than 100 mL, trabeculated bladder mucosa on cystourethroscopy, a history of major pelvic trauma, and fractures that might negatively affect urethral function Mixed incontinence was included provided urodynamics showed normal capacity, normal compliance and stable bladder The 2 groups had similar characteristics with respect to age, parity, hysterectomy, previous incontinence surgery, sensory urge incontinence, preoperative IIQ score
Interventions	A (52) pubovaginal sling B (48) TVT
Outcomes	Objective cure defined as negative cough‐induced stress test with full bladder (at least 250 mL filled) in the lithotomy and standing position and a 1‐h pad‐test ≤ 2 g Subjective cure defined by mean IIQ score in each group Also assessed were: type of anaesthesia, operative time, estimated blood loss, bladder penetration and satisfaction with procedure Incontinent within 1 year (stress test): A: 6/36, B: 3/25  P = 0.9 Incontinent within 1 year (1‐h pad test): A: 10/36, B: 6/25  P = 0.83 Participantsatisfaction at 12 months: A: 20/36, B: 15/25 Operative time (min): A: 80 (50‐180), B: 45 (30‐70) P = 0.01 Length of hospital stay (days): A: 5 (3‐7), B: 2 (1‐5) P = 0.001 Time to catheter removal (days): A: 4.6 (3‐6), B: 1.3 (1‐5) P = 0.001 Complications: de novo urge symptoms: A: 8/36, B: 1/25;  voiding dysfunction: A: 11/36, B: 5/25; bladder perforation: A: 2/36, B: 6/25  P = 0.05; bleeding (> 250mL): A: 1/36, B: 1/25 P = 1.00; suprapubic incisional hernia after 8 months: A: 1/36, B: 1/25
Notes	Procedures performed by single surgeon All participants were preoperatively evaluated by, physical examination, plain abdominal X‐ray, urinary tract ultrasound, cystourethroscopy and urodynamic study Physical examination assessed degree of prolapsed, basal lab tests (FBC, renal and liver function tests, serum electrolytes, urine analysis, culture) Assumption was made that t‐test was used for operative time, catheterisation and hospital stay
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not mentioned
Allocation concealment (selection bias)	Unclear risk	Sealed, opaque envelopes, no mention of numbering
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Not mentioned
Incomplete outcome data (attrition bias) All outcomes	Low risk	All outcomes assessed in randomised groups. 39 participants lost to follow‐up. Similar losses in each group