Smith 2017.
Study characteristics | ||
Methods |
Design: RCT Dates study conducted: offered participation between November 2008 and January 2011 |
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Participants |
Number of participants: 98 Country: USA Setting: single centre Type of UI: SUI
Age: MiniArc: 52.9 years ± 11.2 years; Monarc: 48.9 years ± 9.4 years BMI: MiniArc: 28.4 ± 5.9; Monarc: 26.3 ± 4.7 Parity (median, range): MiniArc: 2 (0 to 4); Monarc: 2 (0 to 4) Duration of SUI: NR Menopause (postmenopausal): MiniArc: 26 (53%); Monarc: 18 (37%) Concomitant POP (overall preoperative POP stage, median and range): MiniArc: 3 (1 to 4); Monarc: 3 (1 to 4) Number receiving concomitant POP surgery
Inclusion criteria: women with SUI objectively confirmed by urodynamics Exclusion criteria: history of incontinence surgery; diagnosis of IDS or low‐pressure urethra made by urodynamic testing (VLPP < 60 cm H2O or MUCP < 40 cm H2O or both); MUI with predominance of DO |
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Interventions |
Group I (n = 49): single incision (MiniArc) Group II (n = 49): transobturator (Monarc) |
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Outcomes |
Primary outcome
Secondary outcomes
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Notes |
Follow‐up: 12 weeks and 24 weeks, then yearly Conflicts of interest: none Study funding source: "Work supported by industry: No" Attempted contact with study authors: we attempted contact with the study authors on 14 November 2022 to clarify which questionnaire was used to measure QoL but received a bounce‐back email. We looked for an email address for the authors on hospital websites and via ResearchGate but could not find an email address for this purpose. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Allocation to treatment group was performed by a computer generated randomsation scheme". |
Allocation concealment (selection bias) | Low risk | Quote: "Subject assignments were sequentially placed in sealed envelopes that were delivered to the operating room and opened by the surgeon after induction of anesthesia at the time of the standard 'Time Out' procedure". |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: notes "nonblinded" but "Subject assignments were sequentially placed in sealed envelopes that were delivered to the operating room and opened by the surgeon after induction of anesthesia at the time of the standard ‘Time Out’ procedure". As such, the personnel were blinded insofar as possible. It is unlikely that participants were blinded, but this was NR. |
Blinding of outcome assessment (detection bias) All outcomes | High risk |
Quote: "nonblinded" Comment: unlikely that outcome assessors were blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 7/49 lost to follow‐up in Monarc arm and 8/49 lost to follow‐up in MiniArc arm; dropouts balanced between groups |
Selective reporting (reporting bias) | Low risk | No evidence of selection bias |
Other bias | Low risk | No other bias detected |