Stress Urinary Incontinence Clinical Trial
Official title:
Comparison of Efficacy and Side Effects Between the Obtryx and Solyx Band With 5-year Follow-up. Prospective, Randomized and Non-inferiority Study
Boston2018 post-market clinical study is a prospective, randomized, non-inferiority study to assess the efficacy and adverse events of the Solyx™ Single Incision Sling (SIS) System compared to the gold-standard Obtryx™ II Sling System, in patients with stress urinary incontinence (SUI) and long-term follow-up (5 years).
Randomized prospective non-inferiority study, in which we evaluate patients with stress urinary incontinence (SUI) who undergo surgical treatment consisting of a minimal incision in the suburethral area of the vaginal mucosa for a mesh insertion in order to: Main Objective: To compare the continence rate (objective) between Solyx and Obtryx II meshes in patients with SUI. This rate will be determined by an effort test. Secondary Objectives: - To compare the continence rate (subjective) between both meshes. - To compare variations in Pad-Test. - To asses patient satisfaction. - To evaluate both techniques regarding quality and sexual life modifications. - To compare both techniques regarding early complications (up to 30 days post implantation). - To compare the appearance and persistence of late complications (from 30 days onwards). ;
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