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

Colombo 2000.

Methods RCT. Open list of computer‐generated random nos. Two arms
 Blinding not mentioned
 No power calculation
 Not ITT but possible
 Follow‐up 8 years to 17 years
Participants N = 71. Dropouts from loss to follow‐up: 2 = Burch; 1 = anterior colporrhaphy
UDS‐confirmed diagnosis. All primary UI. No mixed UI. All had MUCP > 30 cm H20
Mean age: 54.9/55.7 years, parity: 3/3, % menopausal: 66%/67%. Baseline comparison of groups similar
Incl: GSI, grade 2 or 3 cystocoele; (+) Qtip test
 Excl: DI, prev anti‐incontinence or prolapse surgery; pelvic disease requiring laparotomy, high surgical risk
Single centre, university‐based, Dept Ob&Gyn
 Italy
Interventions I: Burch (35)
 II: Anterior colporrhaphy (33)
Both techniques described
Group I had total abdominal hysterectomy ± Moschowitz; Group II had vaginal hysterectomy with Douglas obliteration
Surgeon not mentioned
Outcomes Number cured (subjective and objective)
 Number with recurrent prolapse of grade 2 or 3
 Number with dyspareunia for sexually active
 Length of hospital stay
 Number with post‐op DI
 Vaginal length post‐op
Subjective cure = no incontinence by history; Objective cure = negative stress test
Notes Different anti‐prolapse surgery done in each group
Additional information on methods and outcome results provided by author on further communication
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk computer‐generated random number
Allocation concealment (selection bias) High risk "randomization list was open"
Blinding (performance bias and detection bias) 
 All outcomes Unclear risk not mentioned
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk not mentioned
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk not mentioned
Incomplete outcome data (attrition bias) 
 All outcomes Low risk equivalent proportion of lost to follow‐up between groups
Other bias Unclear risk no other bias identified