Virtue® European Study

NCT01608789 | Completed

• 1 other identifier: SU012
• Study Type: interventional
• Target: 123
• Locations: 8 countries
• Sites: 14

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.

Conditions

Stress Urinary Incontinence

Keywords

Male sling; Stress Urinary Incontinence; Urination Disorders; Urologic Diseases

Outcome Measures

Primary Outcomes (2)

• Improvement of urinary incontinence based on 24-hour pad test

  The primary effectiveness end point will be improvement in pad weight defined as at least a 50% reduction in 24-hour pad weight from baseline to 12-months.

  1 year

• Safety of the device characterized by reported adverse events

  Safety of the device, including the implant procedure.

  1 year

Secondary Outcomes (6)

• Improvement of urinary incontinence based on 24-hour pad test

  Baseline, 1 month, 3 months, 6 months, 2 years, 3 years

• Improvement of urinary incontinence based on number of pad used

  baseline,1 month, 3 months, 6 months, 1 year, 2 years and 3 years

• Improvement of urinary incontinence based on PGI-I

  1 month, 3 months, 6 months, 1 year, 2 years, 3 years

• Assessment of the frequency, severity and impact on quality of life of urinary incontinence based on ICIQ-UI short form

  baseline, 1 months, 3 months, 6 months, 1 year, 2 years and 3 years

• Patient satisfaction questionaire

  1 month, 3 months, 6 months, 1 year, 2 years, 3 years

Study Arms (1)

Virtue® Male Sling

EXPERIMENTAL

Patient implanted Virtue® Male Sling

Device: Virtue® Male Sling

Interventions

Virtue® Male Sling 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).

Virtue® Male Sling

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (14)

Hôpital Erasme

Brussels, 1070, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

Centre Hospitalier Universitaire Henri Mondor

Créteil, 94010, France

Location

Groupe Hospitalo Universitaire Carémeau

Nîmes, 30029, France

Location

Hôpital de la Pitié-Salpêtrière

Paris, 75651, France

Location

Heilig Geist Krankenhaus

Cologne, 50737, Germany

Location

Universitätsklinikum Schleswig-Holstein

Kiel, 24105, Germany

Location

Mater Private Hospital

Dublin, Ireland

Location

Istituto europeo di Oncologia

Milan, 20141, Italy

Location

Hospital Santa Maria della Misericordia

Udine, 33100, Italy

Location

Leiden University Medical Center

Leiden, 23000, Netherlands

Location

Fundacio Puigvert - Universitat Autonoma de Barcelona

Barcelona, 0825, Spain

Location

Hospital Universitario Puerta del Mar

Cadiz, 11009, Spain

Location

Guy's Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress; Urination Disorders; Urologic Diseases

Condition Hierarchy (Ancestors)

Urinary Incontinence; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2012
• First Posted: May 31, 2012
• Study Start: August 27, 2012
• Primary Completion: June 28, 2016
• Study Completion: June 11, 2018
• Last Updated: June 11, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1); FR (3); IT (2); ES (2); BE (2); GB (1); IE (1); DE (2)