Comparison of Efficacy and Side Effects Between the Obtryx and Solyx Band With 5-year Follow-up.
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Stress Urinary Incontinence
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 40 years and 125 years
- Gender
- Only males
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...
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).
Tracking Information
- NCT #
- NCT03916471
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Marta Garcia Instituto de Investigación y Politécnico La Fe
Get Well Soon