OBJECTIVE: To evaluate the impact of a more limited paraurethral dissection, 
avoidance of perforating the obturator membrane with scissors or guide, and a 
more medial trajectory of the trocar in positioning the TVT-O device on stress 
urinary incontinence cure rates.
STUDY DESIGN: One hundred and ten patients were recruited for this randomized, 
single blind, multicenter, non-inferiority study, with a 1:1 ratio to undergo 
the traditional (n=55) or the modified (n=55) technique. Preoperatively, 
patients underwent POP-Q staging, Q-tip test, challenge stress test and 
urodynamics, and completed the I-QoL, PISQ-12, and PGI-S questionnaires. During 
the post-operative period, patients attributed a pain VAS score 1, 3, 6, 12 and 
24h after the procedure and were followed up at 12 months, undergoing the same 
baseline evaluations. The primary outcome was the cure rate (absence of urine 
leaks at the challenge stress test or urodynamic testing) one year after the 
procedure. The primary outcome was evaluated using a non-inferiority test.
RESULTS: No differences were observed in cure rates (traditional technique 92.3% 
vs. modified technique 88.8% and non-inferiority P<0.05) and in questionnaire 
scores between the two groups. Post-operative pain was significantly lower in 
the modified technique group at each time point assessed, with the exception of 
12h post-operatively. No differences between the two groups were observed in the 
number of analgesic vials administered.
CONCLUSIONS: The modified technique does not seem to reduce the efficacy of 
TVT-O, but induces a reduction of post-operative pain.