Albo 2007

Methods	RCT by electronic treatment assignment. 2 arms. Unblinded Follow up at 24 months. Analysis with ITT
Participants	N = 655 4 ineligible after randomisation (3‐Burch, 1‐Sling), 1 did not undergo allocated treatment. Only 520 assessed at end of trial (255‐Burch, 265‐sling) Symptom‐based diagnosis, confirmed by standard stress test Inclusion criteria: documented pure or predominant symptom of SUI for at least 3 months, positive standardised urinary stress test Exclusion criteria: 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 Groups similar in age, ethnic group, marital status, BMI, vaginal deliveries, hormone treatment, smoking, mixed UI, POP, UDS, concomitant surgery Multicentre. Tertiary referral centres. USA
Interventions	A (326): Sling B (329): Burch 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 3‐d voiding diary, POP, adverse events, voiding dysfunction (use of a catheter), postoperative UUI Overall success defined as no self‐reported symptoms of UI, no incontinence on 3‐d diary, negative stress test, no re treatment SUI‐specific success defined as no symptoms, negative stress test and no re treatment for SUI All outcomes reported at 2‐year follow‐up Failure (symptoms) at 24 months: A: 101/265, B: 130/255 Failure (pad test) at 24 months: A: 37/265, B: 38/255 Complications: any complications: A: 206/326, B: 156/329; any voiding dysfunction: A: 46/326, B: 7/329; post‐operative cystitis: A: 247/326, B: 166/329; bladder perforation: A: 2/326, B: 10/329
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	Use of permuted‐block randomisation schedule with stratification according to clinical site
Allocation concealment (selection bias)	Unclear risk	Insufficient information to permit judgement
Blinding (performance bias and detection bias) All outcomes	High risk	Participants were aware of study‐group assignments postoperatively. Independent data and safety monitoring board oversaw the progress, interim results, and safety of the study
Incomplete outcome data (attrition bias) All outcomes	Low risk	135 women were lost to follow‐up at 2 years. 61 from the sling group and 74 from Burch failed to attend clinic To allow for attrition and missed visits, 655 women had been recruited following power calculation