title: Prospective randomized comparison of the transobturator mid-urethral sling with the single-incision sling among women with stress urinary incontinence: 1-year follow-up study.
abstract: OBJECTIVE
  The objective was to compare the efficacy and safety of an innovative single-incision sling (SIS) with the inside-out transobturator sling (TOT) in the treatment of female stress urinary incontinence (SUI).
  
  
  METHODS
  A prospective randomized trial was performed in a tertiary referral urogynecology center from January 2012 to December 2013. The study included women with pure urodynamic SUI. Patients were randomized to either the SIS or the TOT anti-incontinence procedure. Surgery duration, blood loss, and groin pain scores were recorded for each patient. The 1-year follow-up visit included objective and subjective cure parameters, postoperative de novo urgency, complications, and the impact on the patient's life quality.
  
  
  RESULTS
  Of 285 patients assessed for eligibility, a total of 93 patients (32.6 %) were randomized into TOT (n = 48) and SIS groups (n = 45). There were no significant differences in either operating time or blood loss. A statistically significant difference between the two groups was found in pain scores three (5.6 ± 1.8 vs 3.1 ± 2.1, p < 0.001) and 12 h postoperatively (3.8 ± 1.7 vs 2.1 ± 1.7, p < 0.001). After 1 year, there were no significant differences between the TOT and SIS groups in objective cure rates (87.0 % vs 90.9 %; p = 0.399) or patient-reported success rates (91.3 % vs 93.2 %; p = 0.999). Incidence of postoperative de novo urgency did not differ between TOT and SIS patients. Both groups registered a significant improvement in quality of life.
  
  
  CONCLUSIONS
  The Ophira SIS procedure has 1-year success rates comparable to standard TOT with significantly less groin pain in the early postoperative period. Both methods were safe and effective in terms of postoperative urgency and life quality improvement.
authors.affiliation: Department of Obstetrics and Gynecology, Masaryk University Medical School, Obilni trh 11, 602 00, Brno, Czech Republic.
authors.forename: Michaela
authors.initials: M
authors.lastname: Jurakova
authors.affiliation: Department of Obstetrics and Gynecology, Brno University Hospital and Masaryk University Medical School, Jihlavska 20, 625 00, Brno, Czech Republic. martin.huser@gmail.com.
authors.forename: Martin
authors.identifier: http://orcid.org/0000-0002-2482-4819
authors.initials: M
authors.lastname: Huser
authors.affiliation: Department of Obstetrics and Gynecology, Brno University Hospital and Masaryk University Medical School, Jihlavska 20, 625 00, Brno, Czech Republic.
authors.forename: Ivan
authors.initials: I
authors.lastname: Belkov
authors.affiliation: Department of Obstetrics and Gynecology, Brno University Hospital and Masaryk University Medical School, Jihlavska 20, 625 00, Brno, Czech Republic.
authors.forename: Petr
authors.initials: P
authors.lastname: Janku
authors.affiliation: Department of Obstetrics and Gynecology, Brno University Hospital and Masaryk University Medical School, Jihlavska 20, 625 00, Brno, Czech Republic.
authors.forename: Robert
authors.initials: R
authors.lastname: Hudecek
authors.affiliation: Department of Paediatric Anesthesiology and Intensive Care, Brno University Hospital and Masaryk University Medical School, Cernopolni 9, 662 63, Brno, Czech Republic.
authors.forename: Petr
authors.initials: P
authors.lastname: Stourac
authors.affiliation: Institute of Biostatistics and Analyses of Masaryk University Medical School, Kamenice 126/3, 625 00, Brno, Czech Republic.
authors.forename: Jiri
authors.initials: J
authors.lastname: Jarkovsky
authors.affiliation: Department of Obstetrics and Gynecology, Brno University Hospital and Masaryk University Medical School, Jihlavska 20, 625 00, Brno, Czech Republic.
authors.forename: Pavel
authors.initials: P
authors.lastname: Ventruba
mesh_terms: D000368:Aged; D016063:Blood Loss, Surgical; D005260:Female; D005500:Follow-Up Studies; D006119:Groin; D006801:Humans; D008875:Middle Aged; D061646:Operative Time; D010149:Postoperative Pain / Q000209:etiology; D000071066:Patient Reported Outcome Measures; D011446:Prospective Studies; D011788:Quality of Life; D053825:Suburethral Slings / Q000009:adverse effects; D016896:Treatment Outcome; D014550:Urinary Incontinence, Stress / Q000601:surgery*; D053202:Urinary Incontinence, Urge / Q000209:etiology; D013520:Urologic Surgical Procedures / Q000009:adverse effects / Q000379:methods*
keywords: Efficacy; Mid-urethral sling; Patient-reported outcomes; Randomized controlled trial; Single-incision sling; Stress urinary incontinence