Bergman 1989a.
Methods | RCT. Randomisation table (to intervention and surgeon). Three arms Blinding not mentioned No power calculation Not ITT analysis Follow‐up one year | |
Participants | N = 342 enrolled, 298 analysed. Three technically difficult hysterectomy excluded, 41 lost to follow‐up UDS‐confirmed SUI. Only primary incontinence All had pelvic relaxation Mean age: 57 years (range 31‐80), mean parity: 3 (1‐13), 191 were menopausal (received Premarin), 19 had previous vaginal hysterectomy Treatment groups comparable as to age, parity, menopausal status Incl: primary GSI with prolapse requiring vaginal correction Excl: previous anti‐incontinence surgery, DI, other gynae condition needing surgery Single centre, university‐based hospital, urogynaecology unit. USA |
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Interventions | I : Burch (101)
II: Pereyra needle suspension surgery (98)
III: Anterior colporrhaphy (99) All procedures described, standard. Prolapse surgery ± vaginal hysterectomy performed together with anti‐incontinence surgery. |
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Outcomes | Number cured at 3 months and 12 months
UDS parameters (MUCP, functional length, abd pressure transmission)
Days on catheter Cure = no history of UI, no UI on evaluation, negative cough profile on UDS Catheter removed when RU < 50 ml with spontaneous void |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "randomization table" |
Allocation concealment (selection bias) | Unclear risk | not mentioned |
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 | Low risk | no withdrawals mentioned |
Other bias | Unclear risk | no other bias identified |