title: Short-term results of a prospective randomized evaluator blinded multicenter study comparing TVT and TVT-Secur.
abstract: OBJECTIVE
  The aim of this prospective randomized multicenter study was to compare TVT (tension-free vaginal tape) with TVT-Secur in terms of efficacy and safety.
  
  
  METHODS
  We set out to enrol 280 stress incontinent women with a half time interim analysis of short-term cure and a continuous registration of adverse events. Of 133 randomized women, 126 were operated and 123 (TVT n = 62, TVT-Secur n = 61) available for 2 months follow-up.
  
  
  RESULTS
  No significant differences were found between groups regarding demographics or grade of incontinence. At 2 months follow-up, subjective cure rate following TVT-Secur was significantly lower than for TVT (72% and 92%, respectively, p = 0.01). Three major complications occurred in the TVT-Secur group: tape erosion into the urethra, a tape inadvertently placed inside the bladder, and an immediate postoperative bleeding from the corona mortis. No major complications occurred in the TVT group. No significant differences were found between groups regarding perioperative bleeding, hospital stay, urge symptoms, or postoperative urinary tract infections. Median time for surgery was 13 and 22 min for TVT-Secur and TVT, respectively (p < 0.0001).
  
  
  CONCLUSIONS
  In a prospective randomized controlled study, the TVT-Secur procedure had a significantly lower subjective cure rate than the retropubic TVT procedure. Due to this, in addition to three serious complications in the TVT-Secur group, we decided to stop further enrolment after the interim analysis. We discourage from further use of the TVT-Secur.
authors.affiliation: Department of Obstetrics and Gynecology, Skåne University Hospital, Lund and Lund University, SE-22185, Lund, Sweden.
authors.forename: Maria
authors.initials: M
authors.lastname: Andrada Hamer
authors.forename: Per-Göran
authors.initials: PG
authors.lastname: Larsson
authors.forename: Pia
authors.initials: P
authors.lastname: Teleman
authors.forename: Christina
authors.initials: C
authors.lastname: Etén-Bergqvist
authors.forename: Jan
authors.initials: J
authors.lastname: Persson
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D057239:Early Termination of Clinical Trials; D005260:Female; D006801:Humans; D008875:Middle Aged; D019106:Postoperative Hemorrhage / Q000209:etiology; D016037:Single-Blind Method; D053825:Suburethral Slings / Q000009:adverse effects*; D016896:Treatment Outcome; D014522:Urethral Diseases / Q000209:etiology; D014550:Urinary Incontinence, Stress / Q000601:surgery*; D013520:Urologic Surgical Procedures / Q000009:adverse effects / Q000295:instrumentation*