title: Contasure-needleless® compared with Monarc® for the treatment of stress urinary incontinence.
abstract: OBJECTIVE
  For the treatment of stress urinary incontinence (SUI), various retropubic and transobturator techniques have demonstrated high cure rates. Single-incision tapes, such as Contasure-Needleless® (C-NDL), have demonstrated similar cure rates to the inside-out transobturator sling (TVT-O®). The aim of this study was to analyse if C-NDL® is equally as effective as an outside-in transobturator sling (Monarc®) for the treatment of SUI.
  
  
  METHODS
  We carried out a prospective, single-centre, randomised trial. The results were analysed for a non-inferiority test with a minimum postoperative follow-up of 12 months. The objective and subjective cure rates were evaluated by a stress test and a postoperative Sandvik Severity Index respectively. Patient satisfaction and operative complications were registered. The cure was defined by a negative stress test and SSI 0.
  
  
  RESULTS
  A total of 187 patients were included, 89 and 98 undergoing C-NDL® and Monarc® respectively. Epidemiological and clinical data did not show and significant differences between both groups except a high prevalence of women who smoke (15.7% C-NDL® vs 6.1% Monarc®, p 0.03). The negative stress test was negative in 72 patients (80.9%) in C-NDL® compared with 85 (88.5%) in Monarc® (p 0.082). The SSI was 0 in 47 (66.2%) for C-NDL® and 61 (70.1%) for the Monarc® group (p 0.01). There were 14 (16.1%) and 8 (8.3%) dissatisfied patients for the C-NDL® and Monarc® groups respectively (p 0.068). The rate of complications was similar in both groups.
  
  
  CONCLUSIONS
  According to the non-inferiority test, C-NDL® is not inferior to Monarc® (post-surgical SSI test), but it is inferior in the comparison of a negative stress test and patient satisfaction.
authors.affiliation: Hospital Sant Joan de Déu, c/Passeig Sant Joan de Déu 2, CP: 08950, Esplugues de Llobregat, Barcelona, Spain. sfernandezgo@hsjdbcn.org.
authors.forename: Sergi
authors.identifier: http://orcid.org/0000-0002-9138-6978
authors.initials: S
authors.lastname: Fernandez-Gonzalez
authors.affiliation: Parc Sanitari Sant Joan de Déu, c/Cami Vell de la Colonia 25, CP: 08830, Sant Boi de Llobregat, Barcelona, Spain.
authors.forename: Eva
authors.initials: E
authors.lastname: Martinez Franco
authors.affiliation: Hospital Sant Joan de Déu, c/Passeig Sant Joan de Déu 2, CP: 08950, Esplugues de Llobregat, Barcelona, Spain.
authors.forename: Xinxin
authors.initials: X
authors.lastname: Lin Miao
authors.affiliation: Hospital Sant Joan de Déu, c/Passeig Sant Joan de Déu 2, CP: 08950, Esplugues de Llobregat, Barcelona, Spain.
authors.forename: Lluis
authors.initials: L
authors.lastname: Amat Tardiu
mesh_terms: D000368:Aged; D005260:Female; D013509:Gynecologic Surgical Procedures / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods* / Q000706:statistics & numerical data; D006801:Humans; D008875:Middle Aged; D011446:Prospective Studies; D053825:Suburethral Slings / Q000009:adverse effects / Q000706:statistics & numerical data*; D014550:Urinary Incontinence, Stress / Q000601:surgery*
keywords: Monarc®; Needleless®; Single-incision sling; Stress urinary incontinence