title: Randomized controlled trial comparing TVT-O and TVT-S for the treatment of stress urinary incontinence: 2-year results.
abstract: OBJECTIVE
  The aim was to compare the efficacy and safety of single-incision sling TVT-Secur (TVT-S) and transobturator midurethral sling (TVT-O) for the treatment of stress urinary incontinence (SUI) over 2 years' follow-up.
  
  
  METHODS
  This is a randomized controlled trial in which women with SUI were randomly assigned to have either TVT-O (n = 56) or TVT-S (n = 66). Exclusion criteria included: voiding dysfunction, detrusor overactivity, and pelvic organ prolapse beyond the hymen. The primary outcomes were objective and subjective cure rates at a follow-up visit at 24 months, defined as a negative stress test and pad test as well as absence of self-reported SUI symptoms. Secondary endpoints included quality of life assessment using the King's Health Questionnaire (KHQ), and complication and reoperation rates. Analysis was performed using intention to treat, and statistical significance was fixed at 5% (p < 0.05). Statistical methods used were Mann-Whitney, Student's t, Chi-squared, Fisher's, ANOVA, and McNemar's tests.
  
  
  RESULTS
  The groups were similar regarding demographic and clinical preoperative parameters. Objective cure rates for TVT-S and TVT-O groups were 77.3% and 83.6%, while subjective cure rates were 75.7% and 80.3% respectively, with no statistically significant differences between the techniques. There was a significant improvement in all KHQ domains in both groups (p < 0.001). A few complications were observed in our study. The most common perioperative complication was thigh pain associated with TVT-O, while the long-term one was tape exposure observed in 5.3% of TVT-O and in 7.5% of TVT-S cases.
  
  
  CONCLUSIONS
  The efficacy of the TVT-S was similar to that of the TVT-O after 2 years' assessment. This cohort will continue to be followed in order to maintain commitment to contributing data on long-term results.
authors.affiliation: Sector of Urogynecology and Vaginal Surgery, Department of Gynecology, Federal University of São Paulo, Alameda Jaú 759, apt 71, São Paulo, SP, Brazil, Zip Code 01420-001, anamariahmb@yahoo.com.br.
authors.forename: Ana Maria H M
authors.initials: AM
authors.lastname: Bianchi-Ferraro
authors.forename: Zsuzsanna I K
authors.initials: ZI
authors.lastname: Jarmy-DiBella
authors.forename: Rodrigo
authors.initials: R
authors.lastname: de Aquino Castro
authors.forename: Maria Augusta T
authors.initials: MA
authors.lastname: Bortolini
authors.forename: Marair G F
authors.initials: MG
authors.lastname: Sartori
authors.forename: Manoel J B C
authors.initials: MJ
authors.lastname: Girão
mesh_terms: D000328:Adult; D000368:Aged; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008875:Middle Aged; D011183:Postoperative Complications; D011788:Quality of Life; D012086:Reoperation; D053825:Suburethral Slings / Q000009:adverse effects*; D013997:Time Factors; D016896:Treatment Outcome; D014550:Urinary Incontinence, Stress / Q000150:complications / Q000523:psychology / Q000601:surgery*