title: Midterm prospective evaluation of TVT-Secur reveals high failure rate.
abstract: BACKGROUND
  TVT-Secur has been described as a new minimally invasive sling for women's stress urinary incontinence (SUI) management, showing promising results in short-term studies.
  
  
  OBJECTIVE
  Our goal was to evaluate the outcome of this procedure after a midterm follow-up.
  
  
  METHODS
  A prospective evaluation involved 45 consecutive patients presenting SUI associated with urethral hypermobility. Fourteen patients preoperatively reported overactive bladder (OAB) symptoms, but none had objective detrusor overactivity. Eight patients had low maximal urethral closure pressure (MUCP). Four patients had pelvic organ prolapse (POP).
  
  
  METHODS
  Patients with POP were treated under general anesthesia by Prolift and TVT-Secur procedure. The 41 other patients received TVT-Secur under local anesthesia on an outpatient basis. All interventions were made by the same surgeon.
  
  
  METHODS
  Postoperative assessment included pad count, bladder diary, clinical examination with stress test, evaluation of satisfaction with the Patient Global Impression of Improvement (PGI-I) scale, and evaluation of side effects. Patients were classified as cured if they used no pads, had no leakage, and had a PGI-I score < or = 2; as improved in case of reduction of SUI symptoms >50% and PGI-I score < or = 3; and as failure otherwise.
  
  
  CONCLUSIONS
  Mean postoperative follow-up was 30.2 +/- 9.8 mo (range: 11-40 mo). Short-term evaluation showed a 93.5% success rate, but, at last follow-up, only 18 (40%) patients were cured, while 8 (18%) were improved, and 19 (42%) failed. Twelve patients underwent implantation of TVT or transobturator tape during follow-up. Age, MUCP, or OAB were not associated with failure. Side effects were limited to five cases of de novo OAB and three cases of urinary tract infection. This work is limited by the absence of a comparison group.
  
  
  CONCLUSIONS
  Our experience shows that despite its good short-term efficacy, TVT-Secur is associated with a high recurrence rate of SUI. Therefore, TVT-Secur does not seem appropriate for SUI first-line management in women.
authors.affiliation: Department of Urology, Tenon Hospital, Groupe Hospitalo-Universitaire EST, Assistance Publique-Hôpitaux de Paris (AP-HP), University Paris VI, Paris, France. jncornu@hotmail.fr
authors.forename: Jean-Nicolas
authors.initials: JN
authors.lastname: Cornu
authors.forename: Philippe
authors.initials: P
authors.lastname: Sèbe
authors.forename: Laurence
authors.initials: L
authors.lastname: Peyrat
authors.forename: Calin
authors.initials: C
authors.lastname: Ciofu
authors.forename: Olivier
authors.initials: O
authors.lastname: Cussenot
authors.forename: Francois
authors.initials: F
authors.lastname: Haab
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008875:Middle Aged; D017060:Patient Satisfaction; D056887:Pelvic Organ Prolapse / Q000601:surgery*; D011183:Postoperative Complications / Q000453:epidemiology; D011446:Prospective Studies; D012008:Recurrence; D053825:Suburethral Slings; D017211:Treatment Failure; D016896:Treatment Outcome; D053201:Urinary Bladder, Overactive / Q000601:surgery*; D014550:Urinary Incontinence, Stress / Q000601:surgery*; D014552:Urinary Tract Infections / Q000209:etiology