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

Instituto de Investigacion Sanitaria La Fe

Status: Enrolling

Conditions: Stress Urinary Incontinence

Treatments: Device: Solyx™ SIS System; Device: Obtryx™ II System (Halo)

Study type: Interventional

Funder types: Other

Identifiers

NCT03916471

BOSTON2018

Details and patient eligibility

About

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).

Full 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).

Enrollment: 166 estimated patients

Sex: Female

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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166 participants in 2 patient groups

S (SOLYX)

Experimental group

Description:

The Solyx™SIS System is an innovative mid-urethral sling single incision system consisting of a 9 cm long polypropylene mesh, whose mid-urethral portion (4 cm) is detanged to potentially resist deformation and to reduce irritation to the urethral wall. Snap-fit to delivery device tip allows for advanced placement control and, therefore, the tensioning through the forward and reverse functions performed with this delivery device.

Treatment:

Device: Solyx™ SIS System

O (OBTRYX II)

Experimental group

Description:

The Obtryx II System (Halo) is a transobturator sling designed to allow inter-operative adjustability with minimal tissue disruption. It consists of two delivery devices (one patient right and one patient left) and one mesh assembly. The mesh assembly is comprised of a polypropylene knitted mesh with dilator legs and a center tab. At the distal ends of the dilator legs there are association loops designed to be placed in the needle slot of the distal end of the delivery device. The disposable delivery device consists of a handle with a stainless steel needle. The needle is designed to facilitate the passage of the mesh assembly through bodily tissues for placement through the obturator foramen.

Treatment:

Device: Obtryx™ II System (Halo)