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

Barry 2008.

Methods RCT of TOT (Monarc) versus TVT
Random allocation of participants but method of sequence generation and allocation concealment not described
Participants 140 women diagnosed with USI
Participants in both groups had similar background characteristics including age, BMI, parity, HRT use, menopausal status, previous incontinence surgery, prolapse etc
Inclusion criteria: participants had either failed conservative management for symptomatic stress incontinence or required prophylactic incontinence surgery during prolapse repair for occult stress incontinence (no preoperative subjective complaint of urinary stress leakage but found to have USI)
Exclusion criteria: significant voiding dysfunction (maximum urine flow rate < 10th percentile according to Liverpool nomogram and PVR volume > 50 ml); known allergy to polypropylene; immunosuppressant therapy and a past history of neurological disease; urogenital malignancy; fistula or pelvic radiotherapy
Interventions Group A: TOT (n = 58)
 Group B: TVT (n = 82)
Outcomes Outcomes included Immediate‐ and short‐term complications, cure rates and patient satisfaction
Primary outcome: reduction in incidence of bladder injury
Secondary outcomes:
  • other intra‐operative complications

  • improvement of symptomatology

  • incontinence impact

  • improvement in incontinence episodes and pad usage

  • objective improvement on UDS: defined as no visible leakage on coughing at the external urethral meatus

  • postoperative complications, such as sling erosion;

  • blood loss: surgeon's subjective estimate of blood volume lost

  • sexual dysfunction via the BFLUTS questionnaire


Improvement of a particular symptom denoted at least 50% reduction in frequency of occurrence in 3‐day bladder diary when compared to preoperative state
Measures used for assessment included:
  • symptomatology (using standardised, validated BFLUTS)

  • incontinence impact (using standardised, validated short IIQ‐7)

  • 3‐day bladder diary findings and pad usage

  • clinical examination findings (POP‐Q ICS)

  • UDS findings

Notes 23 women from the TVT group and 21 from TOT group were lost to follow‐up. Thus, at follow‐up complete data set available for 82 women in TVT group and 58 in the TOT group. There were no differences between the group unavailable for analysis when compared to those finally analysed
No mention of intraoperative cystoscopy in either group
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Participants were blinded and randomly allocated in a balanced way (blocks of 20) Randomisation was stratified according to a history of previous incontinence surgery
Allocation concealment (selection bias) Unclear risk Unclear
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Participants were blinded. How this was achieved was not explained
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk No information
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No differential loss to follow‐up or differential attrition