Comparison of Efficacy and Side Effects Between the Obtryx and Solyx Band With 5-year Follow-up.

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).

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