Abdel‐Fattah 2010.
Methods | RCT of TVT‐O vs TOT–ARIS | |
Participants | 341 women from the west of Scotland, UK, Urogynaecology tertiary referral centre Inclusion criteria: women with USI or MUI (but with SUI as the predominant troublesome symptom). Women with previous incontinence surgery were included. All women had failed or declined pelvic floor muscle training Exclusion criteria: predominant OAB symptoms; or had specific co‐morbidities such as known neurological conditions (e.g. multiple sclerosis); diabetes; ≥ stage 2 POP‐Q or concomitant surgery, or both There were no significant differences in participant characteristics between the 2 groups Mean age (years): Group A: 51.5; Group B: 52.1 Mean BMI kg/m²: Group A: 28.1; Group B: 28.9 MUI: Group A: 40/170; Group B: 43/171 Previous incontinence surgery: Group A: 28/170; Group B: 18/171 |
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Interventions | Group A: TVT‐O (n = 170) Group B: TOT (n = 171) |
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Outcomes | Primary outcome: absence of USI on UDS Secondary outcome measures:
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Notes | Loss to follow up at 1 year: Group A: 18/170, Group B: 24/171 Loss to follow up at 3 years: Group A: 44/170, Group B: 59/171 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "A single‐blinded, prospective, randomized study … Women were assigned to either procedure by random allocation (computer generated)" |
Allocation concealment (selection bias) | Low risk | Quote: "Allocation was concealed using opaque sealed envelopes, which were opened by the nursing staff on the morning of the operation" |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: “a single‐blinded, prospective, randomized study… Women were informed about the type of operation if they wished, for ethical considerations, but they were instructed not to disclose this information to the clinician at follow‐up” |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: “Post‐operative assessment at 6 months was performed by an independent clinician who was blinded to the type of surgery … “ |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: “No woman assigned to an arm asked to change her operation or to withdraw from the study prior to the operation. Withdrawals, unattendants and untraceables were accounted for without significant inter group differences” |