Albo 2007.
| Methods | RCT by electronic treatment assignment Two arms Not blinded Follow up at 24 months and at 5 years (but this was an extension study where not all patients were enrolled) Analysis with intention to treat |
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| Participants | N = 655
14 ineligible after randomisation (11‐sling, 3‐Burch), 1 did not undergo allocated treatment. Only 520 assessed at end of trial (265‐sling, 255‐Burch) but all included in analysis In the 5‐year follow up, only 482 patients were enrolled in the extension study, and only 357 completed the 5‐year follow up Symptom‐based diagnosis, confirmed by standard stress test Incl: documented pure or predominant symptom of SUI for at least 3 months, positive standardised urinary stress test Excl: age < 21 years, nonambulatory, pregnancy, current cancer chemo‐ or radiotherapy, systemic disease affecting bladder function, urethral diverticulum, prior augmentation cystoplasty or artificial urethral sphincter, recent pelvic surgery, < 12 months postpartum Groups similar in age, ethnic group, marital status, BMI, vaginal deliveries, hormone treatment, smoking, mixed UI, POP, UDS, concomitant surgery Multi‐centre. Tertiary referral centres. USA. |
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| Interventions | I: Burch (329)
II: Sling (326) Burch as modified by Tanagho Sling procedure using autologous rectus fascia at level of the bladder neck and proximal urethra Interventions standardised across the centres |
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| Outcomes | Number with overall success, number with SUI‐specific success, pad test, number of incontinence episodes in a three‐day voiding diary, POP, adverse event, voiding dysfunction (use of a catheter), post‐operative UUI. Overall success defined as no self‐reported symptoms of UI, no incontinence on three‐day diary, negative stress test, no retreatment. SUI‐specific success defined as no symptoms, negative stress test and no retreatment for SUI. All outcomes reported at two years' follow‐up New reports reporting the following outcomes: patient satisfaction |
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| Notes | Full text with several other reports in full text and abstract form | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "randomized"; "use of permuted‐block randomisation schedule with stratification according to clinic site, by electronic treatment assignment |
| Allocation concealment (selection bias) | Unclear risk | no further description of allocation concealment in any of the reports |
| Blinding (performance bias and detection bias) All outcomes | High risk | "unmasked" |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | "unmasked" |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | "unmasked" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Analysis done by intention to treat. Not all patients were examined at the end of the trial (Burch = 74, Sling = 61, did not complete the follow up) |
| Other bias | Unclear risk | no other bias identified |