Tseng 2005.
Methods | RCT comparing TVT with SPARC | |
Participants | 62 women Inclusion criteria: women with USI with or without POP Exclusion criteria: those with POP > ICS stage 2 and those with previous anti‐incontinence surgery Mean age was 51 years and median parity of 3. The 2 groups were similar in terms of age, parity and menopausal status |
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Interventions | Group A: SPARC (n = 31) Group B: TVT (n = 31) | |
Outcomes | Objective cure: defined as pad weight ≤1g Improved: participants whose loss decreased to < half of the preoperative value were considered to have improved |
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Notes | All women had routine suprapubic ultrasonography for detecting unrecognised subcutaneous or retropubic haematoma on the day immediately after the operation, and 7/8 of those with retropubic haematoma of >5 cm diameter were discharged uneventfully from the hospital within 7 days of the operation. Ultrasonography performed at the 1 month follow‐up visit revealed complete resolution of the haematoma for every participant Follow‐up at 2 years Women and their outcome assessors were blinded, but the exact method used to achieve this was unclear |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | By using a predetermined computer‐generated randomisation code, those subjects who acquiesced and satisfied the inclusion criteria were assigned randomly by the authors (except LHT) to the SPARC or TVT procedure at the outpatient clinic |
Allocation concealment (selection bias) | Unclear risk | Unclear |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "The patients were blinded to the procedure, but the principle based on the integral theory was briefly explained to them" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No differential loss to follow‐up or differential attrition |