Contasure-needlelessA® compared with MonarcA® for the treatment of stress urinary incontinence

For the treatment of stress urinary incontinence (SUI), various retropubic and transobturator techniques have demonstrated high cure rates. Single-incision tapes, such as Contasure-NeedlelessA (R) (C-NDL), have demonstrated similar cure rates to the inside-out transobturator sling (TVT-OA (R)). The aim of this study was to analyse if C-NDLA (R) is equally as effective as an outside-in transobturator sling (MonarcA (R)) for the treatment of SUI. 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. A total of 187 patients were included, 89 and 98 undergoing C-NDLA (R) and MonarcA (R) 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-NDLA (R) vs 6.1% MonarcA (R), p 0.03). The negative stress test was negative in 72 patients (80.9%) in C-NDLA (R) compared with 85 (88.5%) in MonarcA (R) (p 0.082). The SSI was 0 in 47 (66.2%) for C-NDLA (R) and 61 (70.1%) for the MonarcA (R) group (p 0.01). There were 14 (16.1%) and 8 (8.3%) dissatisfied patients for the C-NDLA (R) and MonarcA (R) groups respectively (p 0.068). The rate of complications was similar in both groups. According to the non-inferiority test, C-NDLA (R) is not inferior to MonarcA (R) (post-surgical SSI test), but it is inferior in the comparison of a negative stress test and patient satisfaction.