Colombo 1996.
Methods | RCT. Computer‐generated random table. No opaque envelope available. Two arms Blinding not mentioned No power calculation Not ITT Follow‐up 3 years | |
Participants | N = 36. No withdrawals UDS‐confirmed SUI. Only primary UI. No mixed UI Mean age: 47.8/49.2 years; parity 2.1/1.9; menopausal: 22%/39% Baseline comparison of groups similar in age, parity, number of vaginal deliveries, % menopausal, BMI, incontinence score Incl: GSI, grade I urethrocoele, incontinence score of 4 or 8 Excl: MUCP < 20 cm H2O, DI, previous anti‐incontinence surgery Single centre, university‐based, Dept Ob&Gyn Italy |
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Interventions | I: Burch (18)
II: Paravaginal defect repair (18) Both techniques described Culdoplasty done if with deep cul de sac of Douglas in both groups Additional abdominal hysterectomy: Burch = 14, Paravag = 16 Surgeon not mentioned |
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Outcomes | Number cured (objective and subjective)
Number improved (subjective)
Length of stay
Time to spontaneous void
Number with urge symptoms
Number with voiding difficulty
Number with prolapse
UDS parameters Subj Cure = no incontinence by history Obj Cure = no urine loss by stress test Normal void = RU ≤ 50ml Improved = clinical score dropped from 8 to ≤ 4 or from 4 to ≤ 2 |
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Notes | Study discontinued due to ethical issues | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | computer‐generated random table |
Allocation concealment (selection bias) | High risk | "no opaque envelopes available" |
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 | not mentioned |
Other bias | Unclear risk | study was discontinued due to ethical reasons |