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. 2017 Jul 31;2017(7):CD006375. doi: 10.1002/14651858.CD006375.pub4

Richter 2010.

Methods RCT: multi‐centre randomised equivalence trial conducted in the USA
Participants 597 women
Inclusion criteria: age >21 years; predominant SUI for >3 months (urgency UI allowed); positive urinary stress test; bladder volume >300 ml
Exclusion criteria: not defined
Baseline characteristics similar between groups
Mean age (years; SD): Group A: 52.7 (10.5); Group B: 53.1 (11.5)
Previous incontinence surgery: Group A: 38/297; Group B: 41/298
Previous prolapse surgery: Group A: 13/297; Group B: 10/298
Postmenopausal: Group A: 209/297; Group B: 206/298
BMI kg/m²: Group A: 30.6; Group B: 30
HRT: Group A: 81/297; Group B: 90/298
Concomitant pelvic surgery: Group A: 73/298; Group B: 78/299
Interventions Group A: retropubic sling (TVT; n = 298)
Group B: transobturator tapes (TVT‐O, and TOT Monarc; n = 299)
(Group C (?): TVT‐O (inside‐out) ‐ separate data not provided)
(Group D (?): TOT (Monarch, outside‐in) ‐ separate data not provided)
Outcomes Composite primary outcomes:
  • objective cure: negative stress test, dry pad test, no repeat treatment;

  • subjective cure: no SUI symptoms on questionnaire, no leakage in urinary diary


Secondary outcomes:
  • median blood loss

  • median operative time

  • bladder or urethral perforation

  • vaginal perforation

  • voiding dysfunction

  • mesh erosion/exposure

  • vascular injury

  • suprapubic/groin pain

  • de novo urgency incontinence

  • QOL: UDI questionnaire, IIQ questionnaire,

  • Sexual function: assessed via PISQ‐12

Notes TOMUS trial NCT00325039
Per protocol
Lost to follow‐up: Group A: 18/298; Group B: 14/299
PISQ measures dyspareunia, coital incontinence and fear of coital incontinence
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Permuted block randomisation schedule with stratification by centre
Allocation concealment (selection bias) Unclear risk No information
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk No information
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk No information
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Quote: "patients who were lost to follow‐up were considered to have had treatment failure and when patients who were lost to follow‐up were excluded”