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. 2023 Oct 27;2023(10):CD008709. doi: 10.1002/14651858.CD008709.pub4

Smith 2017.

Study characteristics
Methods Design: RCT
Dates study conducted: offered participation between November 2008 and January 2011
Participants Number of participants: 98
Country: USA
Setting: single centre
Type of UI: SUI
  • Urgency: MiniArc: 29 (59%); Monarc: 28 (57%)


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
  • Concomitant POP surgery: MiniArc: 29 (59%); Monarc: 34 (69%)

  • Anterior colporrhaphy: MiniArc: 22 (45%); Monarc: 19 (39%)


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
Interventions Group I (n = 49): single incision (MiniArc)
Group II (n = 49): transobturator (Monarc)
Outcomes Primary outcome
  • Presence of UI: assessed using standardised CST at 1 year. If the CST result was negative in the supine position, the test was repeated with the participant standing and with multiple coughs; any visible sign of leakage was considered to be a positive result.


Secondary outcomes
  • Intraoperative data

  • Subjective complaint of recurrent or persistent SUI

  • Subjective cure

  • Validated questionnaire scores

  • Perioperative and postoperative complications (e.g. voiding dysfunction, mesh exposure and need for repeat incontinence procedures)

  • Postoperative urinary retention: assessed with a standard voiding trial protocol implemented at the study authors' institution that measures PVR volumes after spontaneous voiding using a bladder scanner for all participants on the day of discharge. If PVR volume was > 100 mL following 2 voids, the nurses were instructed to insert a Foley catheter and the participant was re‐evaluated after 72 hours.

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.
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