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

de Leval 2011.

Methods QRCT of TVT‐O vs modified TVT‐O
Participants 175 women
Inclusion criteria: women aged 25‐85 years with USI;
positive stress test with at least a maximum cystometric capacity of 300 ml
Exclusion criteria: DO or detrusor acontractility; neurogenic bladder; or POP stage 3 or above
Mean age years (SD): Group A: 60.0 (11.7); Group B: 57.2 (2.7)
BMI kg/m² (SD): Group A: 26.4 (4.8) Group B: 26.8 (5.3)
Previous surgery for SUI: Group A: 4/87; B Group: 4/88
Previous surgery for POP: Group A: 4/87; Group B: 2/88
Interventions Group A: TVT‐O (n = 87)
Group B: modified TVT‐O (n = 88)
Outcomes At 1 ‐year follow‐up:

  • objective cure: negative cough test

  • subjective cure: disappearance of SUI using symptom scoring system

  • subjective cure and improvement:

  • Intraoperative complications

  • de novo urgency

  • mesh erosion

  • groin pain


At 3‐year follow‐up:

  • objective cure: negative cough test

  • subjective cure
Notes The modified TVT‐O was shortened to a total tape length of 12 cm and had a reduction in the depth of lateral dissection, the obturator membrane was not perforated with the scissors or the guide
Follow‐up assessments carried out at 1, 6, 12 months, and 3 years
Lost to follow‐up:

  • at 1 year: Group A: 3/87; Group B: 2/88

  • at 3‐year follow‐up: Group A: 13/87; Group B: 9/88
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Quote: "The randomisation process was performed with five sequential patients undergoing one approach before alternating surgical modality"
Allocation concealment (selection bias) Unclear risk No information
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Patients were blinded to the type of surgery they underwent
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk No information
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Quote: "no patients withdrew from the study prior to their operation". 2 participants were completely lost to follow‐up after the 1‐month visit and 2 more after the 6‐month visit. One patient died before the 6‐month visit; the cause of death was unrelated to the surgery