Berglund 1996.
Methods | RCT. Method not described. Two arms Blinding not mentioned Not mentioned if ITT analysis No power calculation Follow‐up 1 year | |
Participants | N = 45. No withdrawals mentioned Diagnosis by symptoms alone All primary UI. Unclear if mixed UI included Mean age: 50 years (SD6.6); parity: 2.6; 44% menopausal No baseline comparison of groups Incl: not listed Excl: age > 65, previous anti‐incontinence surgery, other gynaecological disease needing surgery, severe medical disease Single centre, university‐based, Dept of Gyne Sweden |
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Interventions | I: Retropubic urethropexy (30)
II: Pubococcygeal repair (15) Description of techniques referenced : Based on these, the reviewers assessed “Retropubic urethropexy” is also the Marshall‐Marchetti‐Krantz. And “Pubococcygeal repair” is also anterior colporrhaphy Both groups had instructions for pelvic floor exercise from physiotherapist Surgeon not specified |
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Outcomes | Number cured at one year, subjective and objective
Time to catheter removal
Number with severe post‐op pain
Urine loss by 2‐hour pad test
Length of stay
Number of post‐op complications
Number with voiding difficulty Obj Cure = no leak by pad test Subj Cure = no leak by history Catheter removed if residual urine < 100 ml |
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Notes | Berglund paper (primary reference) includes patients excluded in the Lalos 1993 paper | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | method of randomization not described |
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 | Unclear risk | no dropouts/withdrawals reported |
Other bias | Unclear risk | no other bias identified |