Sergi Fernandez-Gonzalez1, Eva Martinez Franco2, Xinxin Lin Miao3, Lluis Amat Tardiu3. 1. Hospital Sant Joan de Déu, c/Passeig Sant Joan de Déu 2, CP: 08950, Esplugues de Llobregat, Barcelona, Spain. sfernandezgo@hsjdbcn.org. 2. Parc Sanitari Sant Joan de Déu, c/Cami Vell de la Colonia 25, CP: 08830, Sant Boi de Llobregat, Barcelona, Spain. 3. Hospital Sant Joan de Déu, c/Passeig Sant Joan de Déu 2, CP: 08950, Esplugues de Llobregat, Barcelona, Spain.
Abstract
INTRODUCTION AND HYPOTHESIS: 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.
RCT Entities:
INTRODUCTION AND HYPOTHESIS: 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: Lucyana M Djehdian; Maita P Araujo; Claudia C Takano; Carlos A Del-Roy; Marair G F Sartori; Manoel J B C Girão; Rodrigo A Castro Journal: Obstet Gynecol Date: 2014-03 Impact factor: 7.661