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Virtue® European Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S
ClinicalTrials.gov Identifier:
NCT01608789
First received: May 28, 2012
Last updated: April 22, 2015
Last verified: April 2015
History of Changes
  Purpose
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.

Condition Intervention Phase
Stress Urinary Incontinence
 Device: Virtue® Male Sling
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Virtue® Male Sling European Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Coloplast A/S:

Primary Outcome Measures:
  • Improvement of urinary incontinence based on 24-hour pad test [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.

  • Safety of the device characterized by reported adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Safety of the device, including the implant procedure.


Secondary Outcome Measures:
  • Improvement of urinary incontinence based on 24-hour pad test [ Time Frame: Baseline, 1 month, 3 months, 6 months, 2 years, 3 years ] [ Designated as safety issue: No ]
  • Improvement of urinary incontinence based on number of pad used [ Time Frame: baseline,1 month, 3 months, 6 months, 1 year, 2 years and 3 years ] [ Designated as safety issue: No ]
  • Subject reported improvement measured by the PGI-I [ Time Frame: 1 month, 3 months, 6 months, 1 year, 2 years, 3 years ] [ Designated as safety issue: No ]
  • Assessment of the frequency, severity and impact on quality of life of urinary incontinence based on ICIQ-UI short form [ Time Frame: baseline, 1 months, 3 months, 6 months, 1 year, 2 years and 3 years ] [ Designated as safety issue: No ]
  • Patient satisfaction questionaire [ Time Frame: 1 month, 3 months, 6 months, 1 year, 2 years, 3 years ] [ Designated as safety issue: No ]
  • Safety of the device characterized by reported adverse events [ Time Frame: Intraoperative, 1 month, 3 months, 6 months, 2 years, 3 years ] [ Designated as safety issue: Yes ]
    Safety of the device, including the implant procedure.
Enrollment: 123
Study Start Date: August 2012
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Virtue® Male Sling Device: 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).

  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01608789

Locations
Belgium
Hôpital Erasme
Brussels, Belgium
Universitair Ziekenhuis Gent
Gent, Belgium
France
Centre Hospitalier Universitaire Henri Mondor
Créteil, France
Groupe Hospitalo Universitaire Carémeau
Nîmes, France
Hôpital de la Pitié-Salpêtrière
Paris, France
Germany
Universitätsklinikum Schleswig-Holstein
Kiel, Germany
Heilig Geist Krankenhaus
Köln, Germany
Ireland
Mater Private Hospital
Dublin, Ireland
Italy
Istituto europeo di Oncologia
Milan, Italy
Hospital Santa Maria della Misericordia
Udine, Italy
Netherlands
Leiden University Medical Center
Leiden, Netherlands
Spain
Fundacio Puigvert - Universitat Autonoma de Barcelona
Barcelona, Spain
Hospital Universitario Puerta del Mar
Cádiz, Spain
United Kingdom
Guy's Hospital
London, United Kingdom
Sponsors and Collaborators
Coloplast A/S
  More Information

Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT01608789     History of Changes
Other Study ID Numbers: SU012 
Study First Received: May 28, 2012
Last Updated: April 22, 2015
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Coloplast A/S:
Male sling
Stress Urinary Incontinence
Urination Disorders
Urologic Diseases

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
 Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 28, 2016