title: Randomized trial of graft materials in transobturator tape operation: biological versus synthetic.
abstract: OBJECTIVE
  To compare the outcome of outside-in biological and synthetic transobturator tape (TOT) operation, including subjective and objective success rates, urodynamics, and quality of life.
  
  
  METHODS
  One hundred patients suffering from clinical and/or urodynamic stress urinary incontinence (SUI) were randomized into biological material TOT (PELVILACE® TO) or synthetic material TOT (ALIGN®TO Urethral Support System) groups. Preoperative and at 1 year postoperative urogynecological symptom assessment, 1-h pad test, 4-day bladder diary, stress test, Q-tip test, and urodynamics were performed. For the evaluation of quality of life, the King's Health Questionnaire, Urogenital Distress Inventory-6, Incontinence Impact Questionnaire-7, and Prolapse Quality of Life were used.
  
  
  RESULTS
  There was no significant difference between the two groups regarding objective and subjective cure rates and quality of life. At 1-year follow-up, the subjective cure rate was 68 % in the biological material TOT and 70 % in the synthetic material TOT group. No perioperative complications developed. Groin pain developed in 2 patients in the biological TOT group and 1 patient had dehiscence in the periurethral incision, which healed with local estrogen. Two patients had transient urinary retention in the synthetic TOT group, 1 patient developed groin pain, and 1 patient had mesh erosion observed at the 1-year follow-up.
  
  
  CONCLUSIONS
  Transobturator tape with biological material in the management of SUI has a rate of success and patient satisfaction similar to those of synthetic material at 1-year follow-up. Studies with longer follow-up and larger cohorts are necessary to evaluate possible autolysis and degradation of biological slings and a possible reduction in efficacy over time.
authors.affiliation: Division of Urogynecology, Department of Obstetrics and Gynecology, Istanbul Medical School, Istanbul University, Atakoy 9. Kisim B6 Blok D40, 34156, Istanbul, Turkey. fgungor@yahoo.com
authors.forename: Funda Gungor
authors.initials: FG
authors.lastname: Ugurlucan
authors.forename: Habibe Ayyildiz
authors.initials: HA
authors.lastname: Erkan
authors.forename: Murat
authors.initials: M
authors.lastname: Onal
authors.forename: Onay
authors.initials: O
authors.lastname: Yalcin
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001672:Biocompatible Materials / Q000627:therapeutic use*; D019468:Disease Management; D005260:Female; D005500:Follow-Up Studies; D013509:Gynecologic Surgical Procedures / Q000379:methods*; D006801:Humans; D008875:Middle Aged; D011788:Quality of Life; D053825:Suburethral Slings; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014550:Urinary Incontinence, Stress / Q000503:physiopathology / Q000601:surgery*; D014563:Urodynamics / Q000502:physiology
chemical_list: D001672:Biocompatible Materials