title: Tension-free vaginal tape-obturator and tension-free vaginal tape-Secur for the treatment of stress urinary incontinence: a 5-year follow-up randomized study.
abstract: OBJECTIVE
  Single-incision slings were developed to overcome the complications related to retropubic and trans-obturator tapes. TVT-Secur was the first of this kind of devices to be marketed and yielded contrasting results. Aim of this non-inferiority study is to report the 5-year follow-up of a randomized, single-blind, controlled trial comparing TVT-O to TVT-Secur.
  
  
  METHODS
  Randomized, single blind, controlled study conducted in two tertiary urogynecological centers. 154 patients were allocated to either TVT-O or TVT-Secur and were contacted 5 years after the procedure to undergo urogynecological examination (POP-Q staging, challenge stress test and post-void residual urine evaluation), to complete I-QOL and PGI-I questionnaires, and to score their satisfaction on a 5-point Likert scale. Patients who were not objectively evaluated were interviewed over the telephone. Primary outcome was subjective success defined as being "very much improved" or "much improved" on the PGI-I.
  
  
  RESULTS
  120 patients were evaluated only subjectively (TVT-O: 62; TVT-Secur: 58) and 84 objectively and subjectively (TVT-O: 46; TVT-Secur: 38). Subjective success (79% vs. 63.8%) and objective cure rates (82.6% vs. 68.4%) 5 years after the procedure were lower for TVT-Secur, but not significantly. Recurrent UTIs were reported by 17.8% of women (TVT-O 9, TVT-Secur 6) and two de novo urgency cases (one per group) were observed. Re-operation rate for stress urinary incontinence (SUI) was 20%.
  
  
  CONCLUSIONS
  TVT-Secur did not show an inferior subjective success rate in comparison with TVT-O five year after the original procedure, even though displaying a clear trend toward a lower efficacy. Considering that the long-term safety profile is similar between the two procedures, there are no advantages in using TVT-Secur.
authors.affiliation: Department of Neurosciences and Reproductive and Odontostomatologic Sciences, University of Naples "Federico II", Naples, Italy. Electronic address: gtommaselli@yahoo.it.
authors.forename: Giovanni A
authors.initials: GA
authors.lastname: Tommaselli
authors.affiliation: Pelvic Floor Center - A.O.R.N. Ospedali dei Colli, Naples, Italy.
authors.forename: Alessandro
authors.initials: A
authors.lastname: D'Afiero
authors.affiliation: Department of Neurosciences and Reproductive and Odontostomatologic Sciences, University of Naples "Federico II", Naples, Italy.
authors.forename: Costantino
authors.initials: C
authors.lastname: Di Carlo
authors.affiliation: Department of Neurosciences and Reproductive and Odontostomatologic Sciences, University of Naples "Federico II", Naples, Italy.
authors.forename: Carmen
authors.initials: C
authors.lastname: Formisano
authors.affiliation: Department of Neurosciences and Reproductive and Odontostomatologic Sciences, University of Naples "Federico II", Naples, Italy.
authors.forename: Annamaria
authors.initials: A
authors.lastname: Fabozzi
authors.affiliation: Department of Public Health, University of Naples "Federico II", Naples, Italy.
authors.forename: Carmine
authors.initials: C
authors.lastname: Nappi
mesh_terms: D000368:Aged; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008875:Middle Aged; D053825:Suburethral Slings; D016896:Treatment Outcome; D014550:Urinary Incontinence, Stress / Q000601:surgery*
keywords: Single-incision sling; Stress urinary incontinence; TVT-O; TVT-Secur