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. 2017 Jul 25;2017(7):CD002912. doi: 10.1002/14651858.CD002912.pub7

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
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.
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
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
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