Bandarian 2011.
| Methods | RCT; simple randomisation method | |
| Participants | N = 62 (Burch = 31, TOT = 31) Incl: proven SUI who were candidates for surgery for the first time, did not respond to treatment Excl: chronic disease such as collagen vascular disease, neuropathy, coagulopathy, history of urogenital cancer, pregnancy, history of pelvic radiation, previous surgery for incontinence, urge incontinence, urodynamic detrusor overactivity or genital prolapse of POP‐Q stage II or more Department of Obstetrics and Gynecology Tehran University of Medical Sciences Tehran, Iran |
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| Interventions | Burch colposuspension (N = 31) TOT (N = 31) All procedures done by one surgeon No description of the interventions |
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| Outcomes | Cure: absence of urinary incontinence Improvement: urinary incontinence less than once in two weeks Failure: urinary incontinence more than once a week (note: paper states "long term outcome" but did not specify any particular time of assessment) Surgical complications such as bleeding, urethral and bladder damage, urinary retention, urinary infection, wound infection, vaginal erosion, pelvic hematoma Hospital stay Operation time Patient satisfaction (asked to express using rate of very satisfied, moderately satisfied, less satisfied and unsatisfied) Mean duration of follow‐up: Burch: 28 months (12‐38) TOT: 22 months (8‐26) (note: no specific time of follow up specified in the methods) Post‐operative follow‐up done by a senior surgeon who did not take part in the operation |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "simple randomisation" |
| Allocation concealment (selection bias) | Unclear risk | not mentioned in the paper |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | not mentioned in the paper |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | "all procedures performed by one surgeon" but no mention specifically regarding blinding |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | "follow up was done by a senior surgeon who did not take part in the operation" but no mention specifically regarding blinding |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | timing of follow‐up was not clearly defined and there is a difference in the mean between the two groups |
| Other bias | Unclear risk | no other bias identified |