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

Colombo 1996.

Methods RCT. Computer‐generated random table. No opaque envelope available. Two arms
 Blinding not mentioned
 No power calculation
 Not ITT
 Follow‐up 3 years
Participants N = 36. No withdrawals
UDS‐confirmed SUI. Only primary UI. No mixed UI
Mean age: 47.8/49.2 years; parity 2.1/1.9; menopausal: 22%/39%
Baseline comparison of groups similar in age, parity, number of vaginal deliveries, % menopausal, BMI, incontinence score
Incl: GSI, grade I urethrocoele, incontinence score of 4 or 8
 Excl: MUCP < 20 cm H2O, DI, previous anti‐incontinence surgery
Single centre, university‐based, Dept Ob&Gyn
 Italy
Interventions I: Burch (18)
 II: Paravaginal defect repair (18)
Both techniques described
Culdoplasty done if with deep cul de sac of Douglas in both groups
Additional abdominal hysterectomy: Burch = 14, Paravag = 16
Surgeon not mentioned
Outcomes Number cured (objective and subjective)
 Number improved (subjective)
 Length of stay
 Time to spontaneous void
 Number with urge symptoms
 Number with voiding difficulty
 Number with prolapse
 UDS parameters
Subj Cure = no incontinence by history
 Obj Cure = no urine loss by stress test
 Normal void = RU ≤ 50ml
 Improved = clinical score dropped from 8 to ≤ 4 or from 4 to ≤ 2
Notes Study discontinued due to ethical issues
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk computer‐generated random table
Allocation concealment (selection bias) High risk "no opaque envelopes available"
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 Unclear risk not mentioned
Other bias Unclear risk study was discontinued due to ethical reasons