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 |