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

Mak 2000.

Methods RCT. Randomisation using computer‐generated random schedule. Used sealed opaque envelopes
 Blinding not mentioned
 No power calculation
 Not mentioned if ITT analysis
 Follow‐up 1 year
Participants N = 90
 No withdrawals
 UDS confirmed SUI
 Mean age: Laparoscopic 51.1 years, open 50.4 years
 Parity Lap 2.7, open 2.9
 Baseline characteristics comparable for age, parity, duration of incontinence, pre‐op pad test, of vaginal deliveries, no. with pre‐existing DI
 Inclusion: UDS‐confirmed SUI
 Excl: ISD, previous anti incontinence surgery, MUCP < 20 cm H20, VLPP < 60 Ccm H20, fibrotic vagina.
Interventions I. Laparoscopic (47)
 II. Open colposuspension (43)
 Co‐intervention: All received bladder training once patient was mobile, some had concomitant hysterectomy
 Procedures described
 Two senior surgeons performed the procedures
Outcomes Number cured (objective cure = dry during urodynamics, subjective cure = cure or improvement according to patient's report) using urinary symptom questionnaire, urodynamics, pad test and quality of life
Length of stay, time to return to normal activities
 Complications
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "randomised according to a computer‐generated random table"
Allocation concealment (selection bias) Low risk "sequentially numbered sealed, opaque envelope"
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 no withdrawals mentioned
Other bias Unclear risk no other bias identified