title: TVT-Secur (Hammock) versus TVT-Obturator: a randomized trial of suburethral sling operative procedures.
abstract: OBJECTIVE
  This study aimed to compare TVT-Secur (TVT-S) and TVT-Obturator (TVT-O) suburethral slings for treatment of stress urinary incontinence (SUI).
  
  
  METHODS
  This was a single-center, nonblinded, randomized trial of women with SUI who were randomized to TVT-S or TVT-O from May 2007 to April 2009. The primary outcome, SUI on cough stress test (CST), and quality-of-life and symptom questionnaires (Pelvic Floor Distress Inventory [PFDI-20] and Pelvic Floor Impact Questionnaire [PFIQ-7]) were assessed at 12 weeks and 1 year.
  
  
  RESULTS
  Forty-three women were randomized to TVT-S and 44 to TVT-O. There were no differences in median baseline PFDI-20 and PFIQ-7. Twenty-two (52.4%) of 42 participants randomized to TVT-S had a positive CST result at evaluation after 12 weeks or 1 year, whereas 4 (9.1%) of the 44 in the TVT-O group had a positive CST result. The intent-to-treat analysis showed that the risk of a positive CST result was 6 times higher after TVT-S than TVT-O (risk ratio, 6.0; 95% confidence interval [CI], 2.3-16.0). Among women not lost to follow-up, the risk ratio for a positive CST result after TVT-S compared with TVT-O was 17.9 (95% CI, 2.5-128.0) at 12 weeks and 3.5 (95% CI, 1.1-11.0) at 1 year. Both TVT-S and TVT-O resulted in improved quality of life and symptoms at 12 weeks. There was no difference between the groups for PFDI-20 (P = 0.40) or PFIQ-7 (P = 0.43). A similar pattern was seen at 1 year (P = 0.85 and P = 0.36).
  
  
  CONCLUSIONS
  The TVT-S seems to have a higher risk of positive postoperative CST result; however, the procedures result in similar improvements in quality of life and symptoms.
authors.affiliation: Department of Obstetrics and Gynecology, Mount Auburn Hospital, Cambridge, MA, USA. lhota@mah.harvard.edu
authors.forename: Lekha S
authors.initials: LS
authors.lastname: Hota
authors.forename: Katherine
authors.initials: K
authors.lastname: Hanaway
authors.forename: Michele R
authors.initials: MR
authors.lastname: Hacker
authors.forename: Anthony
authors.initials: A
authors.lastname: Disciullo
authors.forename: Eman
authors.initials: E
authors.lastname: Elkadry
authors.forename: Patricia
authors.initials: P
authors.lastname: Dramitinos
authors.forename: Alexander
authors.initials: A
authors.lastname: Shapiro
authors.forename: Tanaz
authors.initials: T
authors.lastname: Ferzandi
authors.forename: Peter L
authors.initials: PL
authors.lastname: Rosenblatt
mesh_terms: D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D057194:Intention to Treat Analysis; D008875:Middle Aged; D010149:Postoperative Pain / Q000209:etiology; D011475:Prosthesis Failure; D019919:Prosthesis Implantation / Q000379:methods*; D011788:Quality of Life; D053825:Suburethral Slings; D016896:Treatment Outcome; D014550:Urinary Incontinence, Stress / Q000601:surgery*