| Methods |
RCT. Randomisation table (to intervention and surgeon). Three arms. Blinding not mentioned. No power calculation. Not ITT analysis |
| Participants |
N = 127. 107 at one year, 93 at five years Fourteen lost to follow up at one year. No baseline comparison of treatment groups
Mean age: 55 years (range 29‐77), mean parity: 3 (1‐12), 74 menopausal
UDS‐confirmed SUI. Only primary incontinence
Excl: other gynaecological disease needing surgery, previous anti‐incontinence surgery
Single centre, university based, Urogyne. USA |
| Interventions |
I: Burch (38)
II: modified Pereyra needle suspension surgery (34)
III: Anterior colporrhaphy (35)
All procedures described and referenced.
Done by house staff and one senior surgeon, randomised |
| Outcomes |
Number cured
UDS parameters (functional length, urethral closure pressure, abdominal pressure transmission)
Prolapse
Days on catheter |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
randomisation 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 |
Unclear risk |
"14 lost to follow up" |
| Other bias |
Unclear risk |
no other bias identified |