Sivaslioglu 2007.
| Methods | RCT Computer‐based stratified randomisation using menopausal status as a block |
|
| Participants | N = 100 Incl: urodynamically proven SUI Excl: previous incontinence surgery, urge incontinence, urodynamic detrusor overactivity, genital prolapse of POP‐Q stage II or more both groups similar as regards age, BMI, parity, % post‐menopausal, % hormone replacement therapy, duration of stress urinary incontinence All participants available for evaluation at 1‐year follow‐up (Burch = 51, TOT = 49) Only 63 patients available for evaluation at 2 years (Burch = 31, TOT = 32) Urogynecology department Maternity and Women's Teaching Hospital Ankara, Turkey |
|
| Interventions | Burch (N = 51) ‐ as described by Walters TOT (N = 49) ‐ performed under spinal anaesthesia ‐ described in the paper Cystoscopy routinely performed after both procedures, Foley catheter was removed from the bladder 24 h after the operations; patients discharged when post‐void residual volume was < 100 ml (by ultrasonography) |
|
| Outcomes | Objective Cure = supine cough test negative and patient reported the restoration of urinary incontinence Subjective Cure = if the patient reported the restoration of urinary incontinence bu the supine cough test was positive Duration of procedure Hospital stay Operative complications (bleeding, bladder injury) Post‐operative complications (urinary retention, urinary tract infection) De novo urge incontinence Evaluation done at 6 weeks, 6 months, 1 year and 2 years |
|
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | computer‐based stratified randomisation using menopausal status as a block |
| Allocation concealment (selection bias) | Unclear risk | not mentioned |
| Blinding (performance bias and detection bias) All outcomes | High risk | "patients were not blinded, all procedures performed by first author, postoperative assessment done by a senior surgeon who did not take part in the operation" |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | "patients were not blinded to the operative procedure", all procedures performed by first author |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | "single blind", "postoperative assessment done by a senior surgeon who did not take part in the operation", but no specific mention if this assessor was blinded to the intervention received by participant |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | complete follow up at 1 year assessment; equivalent losses for both groups at 2 year assessment; no reasons given |
| Other bias | Unclear risk | no other bias identified |