Schierlitz 2014.
Methods | Trial design: multi‐centre randomised controlled trial (2 sites) | |
Participants | Number of participants randomised: 80 (no TVT group 43, TVT group 37) Number of participants analysed: at 6 months: no TVT group 39, TVT group 35 Mean age (mean ± SD): no TVT group = 66 ± 9.1, TVT group = 67 ± 10.9 Inclusion criteria: symptomatically continent women with urodynamically demonstrable stress incontinence with or without reduction of prolapse (POPQ ≥ stage 3) Exclusion criteria: contraindications to pelvic surgery such as pelvic infection, fistula, congenital or neurogenic bladder disorder, malignancy, or being medically unfit Setting: 2 tertiary hospitals, Australia Timing: May/June 2003 to August/September 2009 |
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Interventions | Intervention: non‐standardised vaginal prolapse surgery with TVT (n = 37) Comparison: non‐standardised vaginal prolapse surgery without TVT (n = 43) No women had bladder neck plications 6 months minimum review, n = 60 at 24 months |
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Outcomes |
Primary outcome/s: need for subsequent anti‐incontinence surgery due to symptomatic SUI after 6 months Secondary outcome/s: subjective cure rates, intraoperative and postoperative complications, voiding function, urgency, urge urinary incontinence (UUI) symptoms, change in quality of life as assessed by UDI‐6 and IIq‐7, overall satisfaction with prolapse repair |
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Notes | Intention‐to‐treat analysis: not stated Sample size calculation: sample size required calculated at 62 participants (31 per group) based on 90% power to detect a reduction from 50% to 10% in SUI after prolapse repair Trial registration: Australian New Zealand Clinical Trials Registry ACTRN: 12611000844943 Funding: no details Conflicts of interest: study authors report no conflicts of interest Occult SUI was defined as symptomatically continent women with urodynamically demonstrable stress incontinence with or without reduction of the prolapse (POPQ ≥ stage 3) Study authors calculated that a clinician would have to insert 1 TVT sling unnecessarily to prevent 1 woman from needing a sling postoperatively. 2‐year follow‐up; published as an abstract (Walsh et al 2017) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer generated |
Allocation concealment (selection bias) | Unclear risk | No details provided of method used to conceal allocation to treatment groups |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding of patients |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No blinding of assessors |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Some women declined postoperative urodynamic studies as they were asymptomatic, but subjective SUI is main outcome measure. |
Selective reporting (reporting bias) | Low risk | Prespecified outcomes are reported. |
Other bias | Unclear risk | Non‐standardised surgery was performed. |