title: The virtue sling--a new quadratic sling for postprostatectomy incontinence--results of a multinational clinical trial.
abstract: OBJECTIVE
  To successfully perform male sling surgery, and the surgery must achieve proximal urethral relocation and/or bulbar urethral compression. The Virtue quadratic sling is a novel device that incorporates both mechanisms of action. We report the 1-year results of the Virtue sling with fixation and compare it with the results of the initial "unfixed" sling trial.
  
  
  METHODS
  A prospective trial was performed to assess the efficacy and safety of the Virtue sling. Objective success was predefined as >50% decrease in 24-hour pad weight and subjective success as a score of "much" or "very much" better on the Patient Global Impression of Improvement. Subgroups were analyzed by baseline incontinence: mild (<100 g), moderate (100-400 g), and severe (>400 g). After analysis of the 1-year data, a second clinical trial incorporating a novel "fixation" technique was performed, with similar outcome measures.
  
  
  RESULTS
  In the initial cohort, subjective and objective successes were achieved in 41.9% at 12 months. Median pad weight reduction was 51.1% at 12 months and varied with the degree of baseline leakage. In the fixation cohort, subjective and objective successes were 70.9% and 79.2%, median pad weight reduction was 88.3% at 12 months, and efficacy was similar regardless of baseline incontinence. There were no cases of prolonged retention and no severe adverse events.
  
  
  CONCLUSIONS
  The Virtue sling with fixation is a safe and efficacious treatment for postprostatectomy incontinence. Superior 12-month results compared with the unfixed device demonstrate that fixation prevents early sling loosening.
authors: Department of Urology, Stanford University Medical School, Stanford, CA. Electronic address: ccomiter@stanford.edu.
authors: Craig V
authors: CV
authors: Comiter
authors: Department of Urology, Kaiser Permanente Medical Group, San Diego, CA.
authors: Eugene Y
authors: EY
authors: Rhee
authors: Department of Urology, Universite de Sherbrooke, Quebec, Canada.
authors: Le-Mai
authors: LM
authors: Tu
authors: Department of Urology, Sunnybrook Health Sciences Center, Toronto, Canada.
authors: Sender
authors: S
authors: Herschorn
authors: Department of Urology, New York University Langone Medical Center, New York, NY.
authors: Victor W
authors: VW
authors: Nitti
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011468:Prostatectomy / Q000009:adverse effects*; D011474:Prosthesis Design; D019919:Prosthesis Implantation / Q000379:methods; D053825:Suburethral Slings; D014550:Urinary Incontinence, Stress / Q000209:etiology* / Q000601:surgery*; D013521:Urologic Surgical Procedures, Male / Q000379:methods