Colombo 2000.
Methods | RCT. Open list of computer‐generated random nos. Two arms Blinding not mentioned No power calculation Not ITT but possible Follow‐up 8 years to 17 years | |
Participants | N = 71. Dropouts from loss to follow‐up: 2 = Burch; 1 = anterior colporrhaphy UDS‐confirmed diagnosis. All primary UI. No mixed UI. All had MUCP > 30 cm H20 Mean age: 54.9/55.7 years, parity: 3/3, % menopausal: 66%/67%. Baseline comparison of groups similar Incl: GSI, grade 2 or 3 cystocoele; (+) Qtip test Excl: DI, prev anti‐incontinence or prolapse surgery; pelvic disease requiring laparotomy, high surgical risk Single centre, university‐based, Dept Ob&Gyn Italy |
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Interventions | I: Burch (35)
II: Anterior colporrhaphy (33) Both techniques described Group I had total abdominal hysterectomy ± Moschowitz; Group II had vaginal hysterectomy with Douglas obliteration Surgeon not mentioned |
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Outcomes | Number cured (subjective and objective)
Number with recurrent prolapse of grade 2 or 3
Number with dyspareunia for sexually active
Length of hospital stay
Number with post‐op DI
Vaginal length post‐op Subjective cure = no incontinence by history; Objective cure = negative stress test |
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Notes | Different anti‐prolapse surgery done in each group Additional information on methods and outcome results provided by author on further communication |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | computer‐generated random number |
Allocation concealment (selection bias) | High risk | "randomization list was open" |
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 | equivalent proportion of lost to follow‐up between groups |
Other bias | Unclear risk | no other bias identified |