Overview
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).
Description
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).
Eligibility
Inclusion Criteria:
- patients diagnosed with symptomatic stress urinary incontinence candidates for stress-free bands
- Age > or = 40 years
- informed consent signed by the patient
Exclusion Criteria:
- patients who are pregnant or wish to become
- patients who need anticoagulant
- active vaginal or urinary infection
- previous surgical interventions for the treatment of incontinence
- body mass index > 35