title: Efficacy of a modified technique for TVT-O positioning: a twelve-month, randomized, single-blind, multicenter, non-inferiority study.
abstract: 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.
  
  
  METHODS
  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.
authors.affiliation: Department of Obstetrics and Gynecology, University of Naples Federico II, Naples, Italy. gtommaselli@yahoo.it
authors.forename: Giovanni A
authors.initials: GA
authors.lastname: Tommaselli
authors.forename: Alessandro
authors.initials: A
authors.lastname: D'Afiero
authors.forename: Costantino
authors.initials: C
authors.lastname: Di Carlo
authors.forename: Carmen
authors.initials: C
authors.lastname: Formisano
authors.forename: Annamaria
authors.initials: A
authors.lastname: Fabozzi
authors.forename: Carmine
authors.initials: C
authors.lastname: Nappi
mesh_terms: D000368:Aged; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D057194:Intention to Treat Analysis; D007558:Italy; D059012:Lost to Follow-Up; D008875:Middle Aged; D010147:Pain Measurement; D010149:Postoperative Pain / Q000517:prevention & control; D010352:Patient Dropouts; D011788:Quality of Life; D016037:Single-Blind Method; D053825:Suburethral Slings / Q000009:adverse effects; D011795:Surveys and Questionnaires; D013810:Therapeutic Equivalency; D014550:Urinary Incontinence, Stress / Q000601:surgery* / Q000652:urine; D014563:Urodynamics; D013520:Urologic Surgical Procedures / Q000009:adverse effects