Ankardal 2001.
Methods | RCT. Method not described. Three arms. Blinding not mentioned. No power calculation. Not stated if ITT analysis. Follow up at 1 year | |
Participants | N = 187. Recruited 211 but only 198 with one year follow up at time of report Groups comparable at baseline Only primary incontinence. Some patients with mixed incontinence Excl: recurrent UI, other major surgery |
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Interventions | I: Burch (79)
II: Lap with mesh and staplers (72)
III: Lap with sutures (49) Techniques for open and lap described Participating surgeons with pre‐specified skill level |
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Outcomes | Number with objective and subjective continence Subjective cure : report as “dry” Objective cure : <8g leakage/24 hours Stress objective cure : <5g leakage / 24 hours Operative time Hospital stay (number of postoperative nights in hospital) QoL using a VAS Complications (Bladder perforation, hematoma, UTI, wound infection, urinary retention >5 days) |
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Notes | Full text | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | method of randomization not mentioned |
Allocation concealment (selection bias) | Low risk | used opaque dealed envelopes |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | not mentioned |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | not mentioned |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | not mentioned |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | not mentioned |
Other bias | Unclear risk | no other source of bias identified |