title: Comparison of the efficacy of tension-free vaginal tape obturator (TVT-O) and single-incision tension-free vaginal tape (Ajust™) in the treatment of female stress urinary incontinence: a 1-year follow-up randomized trial.
abstract: OBJECTIVE
  The aim of this study was to compare the efficacy of the tension-free vaginal tape obturator (TVT-O) and single-incision tension-free vaginal tape (Ajust™) in the treatment of stress urinary incontinence in a randomized two-arm study with a 1-year follow-up.
  
  
  METHODS
  This single-centre randomized trial compared the objective and subjective cure rates of TVT-O and Ajust using objective criteria (cough test) and subjective criteria (International Consultation on Incontinence Questionnaire short form, ICIQ-UI SF). The objective cure rate was defined as the number of patients with a negative cough stress test. Subjective cure was defined as no stress leakage of urine after surgery based on the ICIQ-UI SF. The primary outcome was to establish differences in objective and subjective cure rates between the TVT-O and Ajust groups. We also compared postoperative pain profiles using a visual analogue scale (VAS), improvement in quality of life using the ICIQ- UI SF and the Incontinence Quality of Life questionnaire, and overall satisfaction with the surgical procedure using a VAS and a five-item Likert scale. Inclusion criteria were age over 18 years, signed informed consent, and urodynamic stress urinary incontinence. Following a power calculation, 50 patients were enrolled into each group (Ajust and TVT-O).
  
  
  RESULTS
  The mean follow-up after surgery was 445 days (SD 157.6 days) in the TVT-O group and 451.8 days (SD 127.6 days) in the Ajust group (p = 76.6 %). At 1 year, 47 patients were evaluated in the TVT-O group and 49 in the Ajust group. No differences in subjective cure rates or objective cure rates were observed. In the Ajust and TVT-O groups, the rates for no subjective stress leakage were 89.8 % and 91.5 %, respectively (p = 1.0, OR 1.22, 95 % CI 0.24 - 6.58), and the rates for a negative stress test were 89.8 % and 87.2 %, respectively (p = 0.76, OR 0.77, 95 % CI 0.17 - 3.32). In the Ajust group two patients reported de novo pain during sexual intercourse.
  
  
  CONCLUSIONS
  After a 1-year-follow-up, no significant differences were found with regard to subjective and objective outcomes between the single-incision tape Ajust and TVT-O.
authors.affiliation: Department of Obstetrics and Gynaecology, 1st Medical Faculty, Charles University and General University Hospital in Prague, Prague, Czech Republic.
authors.forename: Jaromir
authors.initials: J
authors.lastname: Masata
authors.affiliation: Department of Obstetrics and Gynaecology, 1st Medical Faculty, Charles University and General University Hospital in Prague, Prague, Czech Republic. kamil@svabik.cz.
authors.forename: Kamil
authors.initials: K
authors.lastname: Svabik
authors.affiliation: Faculty of Sciences, Charles University Prague, Prague, Czech Republic.
authors.forename: Karel
authors.initials: K
authors.lastname: Zvara
authors.affiliation: Department of Obstetrics and Gynaecology, 1st Medical Faculty, Charles University and General University Hospital in Prague, Prague, Czech Republic.
authors.forename: Petr
authors.initials: P
authors.lastname: Hubka
authors.affiliation: 1st Faculty of Medicine, Charles University Prague, Prague, Czech Republic.
authors.forename: Ales
authors.initials: A
authors.lastname: Toman
authors.affiliation: Department of Obstetrics and Gynaecology, 1st Medical Faculty, Charles University and General University Hospital in Prague, Prague, Czech Republic.
authors.forename: Alois
authors.initials: A
authors.lastname: Martan
mesh_terms: D000328:Adult; D000368:Aged; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008875:Middle Aged; D010149:Postoperative Pain; D011300:Preoperative Care; D011788:Quality of Life; D053825:Suburethral Slings; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D014550:Urinary Incontinence, Stress / Q000601:surgery*; D013520:Urologic Surgical Procedures / Q000379:methods*
keywords: Ajust™; Single incision midurethral sling; Stress urinary incontinence; Surgical treatment; TVT-O