Basok 2008

Methods	RCT. Details of randomisation not given. Two arms. Follow‐up 12 months
Participants	139 women randomised. Baseline comparison made: number of participants, mean age (years), mean daily pad usage, mean parturition, mean BMI, mixed urinary incontinence.  No statistical difference Inclusion criteria: stress urinary incontinence due to urethral hypermobility Exclusion criteria: participants with ISD, uterine prolapse, rectocele, enterocele, grade III or IV cystocele Concomitant urinary urge incontinence was present in some women with mixed urinary incontinence present in 49 participants (73%) in the fascia lata sling group and in 44 participants (61%) in the intravaginal slingplasty group
Interventions	A (67) Cadaveric fascia lata B (72) Intravaginal slingplasty
Outcomes	Objective cure rate was evaluated by the pad test, and participant‐satisfaction rate was assessed by a subjective questionnaire. A cure and an improvement were defined as a totally dry participant and 1 pad/d, respectively. Usage of more than 1 pad/d was accepted as surgical failure. The sum of cure and improvement rates was conceded as a total success rate. Other outcomes measured were: mean operating time, bladder perforation, urinary retention, erosion, sling revision, haematoma, persistent urge urinary incontinence,  defective vaginal wall, de novo detrusor overactivity. Total success: A: 79.0%, B: 70.8 Satisfaction at 12 months: A: 82.0%, B: 87.5% Incontinent at 12 months: A: 32/67, B: 38/72 Not improved at 12 months: A: 14/67, B: 21/72 Daily mean pad usage (SD): A: 4.1 (3.5), B: 2.9 (1.7) Operative time: A: 50, B: 25 min Adverse events: de novo detrusor overactivity: A: 15/67, B: 5/72; bladder perforation: A: 3/67, B: 8/72; urinary retention: A: 8/67, B: 8/72; vaginal erosion: A: 0/67, B: 0/72; sling revision: A: 2/67, B: 0/72
Notes	Preoperative evaluation of all participants included: urogynaecological history, previous pelvic surgery, voiding diary, parturition and daily pad usage The abstract indicated that the QOL was significantly improved in the study, the full article showed that measurement was carried out by participant‐satisfaction questionnaire. No comment was made on the validity and reliability of this questionnaire
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