Su 1997.
| Methods | Design: quasi‐RCT | |
| Participants | 92 women with urinary incontinence confirmed by pad test and objective stress test Exclusion criteria: pathological conditions that might limit vaginal wall flexibility, uterine prolapse or cytocele greater than first degree' DI, underactive detrusor or outflow obstruction, previous continence surgery, previous hysterectomy |
|
| Interventions | Group I (n = 46): LC using sutures Group II (n = 46): OC |
|
| Outcomes | Objective cure, 1‐h pad test, urodynamics, operative time, blood loss, duration of bladder drainage, complications with 1 year | |
| Notes | Follow‐up: 1 year Most data not reported in useable form |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | Quote: "Patients were randomized according to a computer generated random number table; the group was assigned by opening the next sealed, opaque envelope. Only a few patients were unwilling to undergo laparoscopic colposuspension. They were, thus, enrolled in the traditional groups. Then, the next patient was assigned to the laparoscopic procedure and the following patients went back to the sequence of the random number table" |
| Allocation concealment (selection bias) | High risk | Quote: "Patients were randomized according to a computer generated random number table; the group was assigned by opening the next sealed, opaque envelope. Only a few patients were unwilling to undergo laparoscopic colposuspension. They were, thus, enrolled in the traditional groups. Then, the next patient was assigned to the laparoscopic procedure and the following patients went back to the sequence of the random number table" |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not reported |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Data provided for all participants |
| Selective reporting (reporting bias) | Low risk | Outcomes seem to be reported in full |
| Other bias | Low risk | No other potential source of bias was identified |