Virtue® European Study

NCT ID: NCT01608789

Last Updated: 2020-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 123 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-27
• Study Completion Date: 2018-06-11

Brief Summary

This study is a prospective, single arm, non-randomized, multi-center clinical study that will be conducted in Europe. It is designed to assess efficacy and safety of the Virtue® Male Sling in post-prostatectomy urinary incontinence.

Detailed Description

This study is a prospective, single arm, non-randomized, multi-center clinical study that will be conducted at up to thirteen centers in Europe. It is designed to assess efficacy and safety of the Virtue® Male Sling. One hundred and twenty-one subjects, satisfying criteria for selection, will be implanted with no more than 15 implanted per site. The study's primary end point will be evaluated at 12 months with continued data collection through 36 months.

Conditions

Stress Urinary Incontinence

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Virtue® Male Sling

Patient implanted Virtue® Male Sling

Group Type: EXPERIMENTAL

Virtue® Male Sling

Intervention Type: DEVICE

The Coloplast Virtue® Male Sling is a Class II, implantable, sub-urethral, permanent, non-absorbable support sling indicated for the surgical treatment of male stress urinary incontinence (SUI) resulting from intrinsic sphincter deficiency (ISD).

Interventions

Virtue® Male Sling

The Coloplast Virtue® Male Sling is a Class II, implantable, sub-urethral, permanent, non-absorbable support sling indicated for the surgical treatment of male stress urinary incontinence (SUI) resulting from intrinsic sphincter deficiency (ISD).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• The subject has an estimated life expectancy of more than 5 years

• The subject has confirmed stress urinary incontinence (SUI) through medical history, urodynamics, and/or physical exam for at least 6 months
• The subject has intrinsic sphincter deficiency due to radical prostatectomy completed at least 1 year prior to implantation date
• The subject has a good bladder function
• The subject has failed non-invasive therapies, eg. Pelvic Floor/Kegel exercises, behavioral modification, or biofeedback, for at least 6 months
• The subject is willing to have the Virtue® Male Sling implanted
• The subject is able and willing to complete all follow-up visits and procedures indicated in this protocol

Exclusion Criteria

• The subject is unable or unwilling to comply with all follow-up requirements according to the study protocol

• The subject has an active urinary tract infection or active skin infection in region of surgery (temporary exclusion)
• The subject has compromised immune systems or any other conditions that affect healing
• The subject has serious bleeding disorders
• The subject has an urinary incontinence that is not mainly a stress urinary incontinence
• The subject has a stress urinary incontinence due to TransUrethral Resection or laser surgery of the Prostate (TURP)
• The subject has incontinence due to neurogenic causes defined as multiple sclerosis, spinal cord/brain injury, CVA, detrusor-external sphincter dyssynergia, Parkinson's disease, or similar conditions
• The subject had a previous implant (male sling, Artificial Urinary Sphincter) to treat stress urinary incontinence (previous implanted bulking agents are allowed)
• The subject has undergone radiation, cryosurgery, or brachy therapy to treat prostate or other pelvic cancer within 6 months
• The subject is likely to undergo radiation therapy within the next 3 months
• The subject has a postvoid residual (PVR) > or = 150mL
• The subject has recently required transurethral instrumentation for urethral or urethro-vesical anatomosis stricture within the previous 6 months
• The subject is enrolled in a concurrent clinical study of any treatment (drug or device) that could affect continence function without the sponsors' approval
• The subject is deemed unfit for male sling implantation or participation in a research protocol as determined by the attending physician

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Coloplast A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital Erasme

Brussels, , Belgium

Universitair Ziekenhuis Gent

Ghent, , Belgium

Centre Hospitalier Universitaire Henri Mondor

Créteil, , France

Groupe Hospitalo Universitaire Carémeau

Nîmes, , France

Hôpital de la Pitié-Salpêtrière

Paris, , France

Heilig Geist Krankenhaus

Cologne, , Germany

Universitätsklinikum Schleswig-Holstein

Kiel, , Germany

Mater Private Hospital

Dublin, , Ireland

Istituto europeo di Oncologia

Milan, , Italy

Hospital Santa Maria della Misericordia

Udine, , Italy

Leiden University Medical Center

Leiden, , Netherlands

Fundacio Puigvert - Universitat Autonoma de Barcelona

Barcelona, , Spain

Hospital Universitario Puerta del Mar

Cadiz, , Spain

Guy's Hospital

London, , United Kingdom

Countries

Belgium; France; Germany; Ireland; Italy; Netherlands; Spain; United Kingdom

Other Identifiers

SU012

Identifier Type: -

Identifier Source: org_study_id