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

Nyyssonen 2014.

Methods RCT of TVT (Gynecare) vs TOT ('outside‐in' Monarc)
Participants 100 women
Inclusion criteria: women with SUI or MUI with a predominant stress component, after failed conservative treatment
Exclusion criteria: urge incontinence; previous mini invasive operation for SUI and the need for another concomitant surgical procedure
SUI diagnosed with a positive cough test
Urodynamic testing was only done in 5 patients (10%)
Pure SUI: Group A: 38/50; Group B: 30/50
Preoperative characteristics similar between groups
Interventions Group A: TOT (n = 50)
Group B: TVT (n = 50)
Outcomes
  • Subjective cure at 14 and 46 months: success defined as a postoperative UISS < 8 and failure as ≥ 8

    • At 14 months

    • At 46 months

  • Vaginal tape erosion

  • Voiding dysfunction

  • De novo UUI


Follow‐up at 3, 14 and 46 months
Cough stress test was performed.
Subjective cure and patient satisfaction recorded with aid of UISS and Detrusor Instability Score questionnaires with a specific question about satisfaction
Notes Cystoscopy only performed in the TVT group
Number available for follow‐up assessments:
14 months: Group A: 43/50; Group B: 43/50
At 46 months: Group A: 46/50; Group B: 47/50
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "This prospective randomized study included ... 100 patients were randomized either to the TVT or to the TOT"
Allocation concealment (selection bias) Low risk Quote: "randomization was performed with sealed and numbered envelopes"
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 Low risk No evidence suggestive of attrition bias