NCT03916471

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 166 (estimated)
• Sponsor: Instituto de Investigacion Sanitaria La Fe · Academic / Other
• Sex: Female
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed 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).

Conditions

• Stress Urinary Incontinence

Interventions

Type	Name	Description
DEVICE	Solyx™ SIS System	Single-incision sling system
DEVICE	Obtryx™ II System (Halo)	Transobturator Mid-urethral Sling System

Timeline

• Start date: 2018-12-21
• Primary completion: 2025-01-01
• Completion: 2025-01-01
• First posted: 2019-04-16
• Last updated: 2023-09-28

Locations

1 site across 1 country: Spain