Barry 2008.
Methods | RCT of TOT (Monarc) versus TVT Random allocation of participants but method of sequence generation and allocation concealment not described |
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Participants | 140 women diagnosed with USI Participants in both groups had similar background characteristics including age, BMI, parity, HRT use, menopausal status, previous incontinence surgery, prolapse etc Inclusion criteria: participants had either failed conservative management for symptomatic stress incontinence or required prophylactic incontinence surgery during prolapse repair for occult stress incontinence (no preoperative subjective complaint of urinary stress leakage but found to have USI) Exclusion criteria: significant voiding dysfunction (maximum urine flow rate < 10th percentile according to Liverpool nomogram and PVR volume > 50 ml); known allergy to polypropylene; immunosuppressant therapy and a past history of neurological disease; urogenital malignancy; fistula or pelvic radiotherapy |
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Interventions | Group A: TOT (n = 58) Group B: TVT (n = 82) | |
Outcomes | Outcomes included Immediate‐ and short‐term complications, cure rates and patient satisfaction Primary outcome: reduction in incidence of bladder injury Secondary outcomes:
Improvement of a particular symptom denoted at least 50% reduction in frequency of occurrence in 3‐day bladder diary when compared to preoperative state Measures used for assessment included:
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Notes | 23 women from the TVT group and 21 from TOT group were lost to follow‐up. Thus, at follow‐up complete data set available for 82 women in TVT group and 58 in the TOT group. There were no differences between the group unavailable for analysis when compared to those finally analysed No mention of intraoperative cystoscopy in either group |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Participants were blinded and randomly allocated in a balanced way (blocks of 20) Randomisation was stratified according to a history of previous incontinence surgery |
Allocation concealment (selection bias) | Unclear risk | Unclear |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Participants were blinded. How this was achieved was not explained |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No differential loss to follow‐up or differential attrition |