Wang 2006.
Methods | RCT of TOT (Monarc) and SPARC suburethral sling procedures | |
Participants | 60 women with an average age of 50 years (SD 10.71 )
Inclusion criteria: women with USI Exclusion criteria: women suffering from preoperative voiding dysfunction, which was defined as either: free Q max of ≤ 12ml/s in repeated free uroflow studies combined with Pdet Q max of ≥20cm H2O, PVR urine ≥ 100 ml, and participants with a pad increase of at least 10cm H2O, compared to the baseline abdominal pressure in a pressure‐flow study. Women who had previous anti‐incontinence surgery and/or with pelvic prolapse > stage 2 of the ICS grading system were also excluded. |
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Interventions | Group A: Monarc (n = 31) Group B: SPARC (n = 29) |
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Outcomes | Assessed via 1‐hr pad test, multichannel urodynamic assessment, complications and postoperative voiding function. Transabdominal USS to detect subcutaneous, retropubic or obturator haematoma | |
Notes | The women were blinded to the procedure performed Intraoperative cystoscopy was performed in both groups |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "By using a predetermined computer‐generated randomisation code ... were assigned randomly by the senior author ..." |
Allocation concealment (selection bias) | Unclear risk | No information |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: " ... The patients were blinded to the procedure ..." How this was achieved was not explained |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "an independent continence advisor and one of the authors both of whom were blinded to the procedures performed carried out the follow‐up examinations and post operative outcome assessments" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No differential loss to follow‐up or differential attrition |