title: Bladder injury and success rates following retropubic mid-urethral sling: TVT EXACT™ vs. TVT™.
abstract: OBJECTIVE
  Although placement of a retropubic mid-urethral slings (MUS) is one of the gold standard surgical treatments for stress urinary incontinence, new devices are poorly evaluated before marketing. We compared TVT-EXACT™ (TVT-E), a new device expected to reduce bladder injuries, with the historically described bottom-to-top TVT™ (TVT).
  
  
  METHODS
  This retrospective study compared TVT-E (n=49) and TVT (n=49). The main outcomes were the prevalence of complications (bladder injuries, immediate postoperative pain, perioperative complications, etc.) and the short-term success rate (no reported urinary leakage and negative cough test) of both MUSs.
  
  
  RESULTS
  Minimum follow-up was 12 months. The characteristics of the two groups were comparable. The prevalence of bladder injury for TVT-E and TVT was 8% and 6%, respectively (p=1). The intensity of immediate postoperative pain (VAS/100) was lower following TVT-E than after TVT (8.0 vs. 15.9, p=0.01). The first post-void residual was increased in the TVT-E group (153.9 vs. 78.9mL, p=0.045), and there were more postoperative bladder outlet obstruction (BOO) symptoms in the TVT-E group (24% vs. 6%, p=0.02). However, there was no difference when considering only de novo BOO (14% vs. 4%, p=0.16). The prevalence of peri- and post-operative complications was equal in the two groups. The success rate was similar at 12 months of follow-up (80 vs. 82%, p=1).
  
  
  CONCLUSIONS
  The prevalence of bladder injury was unchanged with TVT-EXACT™ compared with TVT™, but post-operative pain was decreased. The success rate of both retropubic MUSs was similar at 12 months of follow-up.
authors.affiliation: APHP, Hôpitaux Universitaires Paris Sud, Hôpital Antoine Béclère, Service de Gynécologie Obstétrique et Médecine de la Reproduction, Clamart F-94000, France.
authors.forename: Thibault
authors.initials: T
authors.lastname: Thubert
authors.affiliation: APHP, Hôpitaux Universitaires Paris Sud, Hôpital Antoine Béclère, Service de Gynécologie Obstétrique et Médecine de la Reproduction, Clamart F-94000, France.
authors.forename: Virginie
authors.initials: V
authors.lastname: Canel
authors.affiliation: APHP, Hôpitaux Universitaires Paris Sud, Hôpital Antoine Béclère, Service de Gynécologie Obstétrique et Médecine de la Reproduction, Clamart F-94000, France.
authors.forename: Marie
authors.initials: M
authors.lastname: Vinchant
authors.affiliation: APHP, Hôpitaux Universitaires Paris Sud, Hôpital Antoine Béclère, Service de Gynécologie Obstétrique et Médecine de la Reproduction, Clamart F-94000, France.
authors.forename: Ingrid
authors.initials: I
authors.lastname: Wigniolle
authors.affiliation: APHP, Hôpitaux Universitaires Paris Sud, Hôpital Bicêtre, Service de Gynécologie Obstétrique, Le Kremlin Bicetre F-94275, France.
authors.forename: Hervé
authors.initials: H
authors.lastname: Fernandez
authors.affiliation: APHP, Hôpitaux Universitaires Paris Sud, Hôpital Antoine Béclère, Service de Gynécologie Obstétrique et Médecine de la Reproduction, Clamart F-94000, France. Electronic address: Xavier.deffieux@aphp.fr.
authors.forename: Xavier
authors.initials: X
authors.lastname: Deffieux
mesh_terms: D000328:Adult; D000368:Aged; D016022:Case-Control Studies; D005260:Female; D006801:Humans; D015994:Incidence; D007431:Intraoperative Complications / Q000453:epidemiology* / Q000209:etiology; D008875:Middle Aged; D010149:Postoperative Pain / Q000453:epidemiology* / Q000209:etiology; D011183:Postoperative Complications / Q000453:epidemiology* / Q000209:etiology; D015995:Prevalence; D012189:Retrospective Studies; D053825:Suburethral Slings / Q000009:adverse effects*; D016896:Treatment Outcome; D001743:Urinary Bladder / Q000293:injuries*; D014550:Urinary Incontinence, Stress / Q000601:surgery*
keywords: Bladder injury; Post-operative pain; Retropubic midurethral sling; TVT™; Urinary incontinence