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Virtue® European Study

This study is not yet open for participant recruitment.
Verified May 2012 by Coloplast A/S
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S
ClinicalTrials.gov Identifier:
NCT01608789
First received: May 28, 2012
Last updated: NA
Last verified: May 2012
History: No changes posted
  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.


Estimated Enrollment: 121
Study Start Date: June 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2014 (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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01608789

Contacts
Contact: Hugo Ryckebusch, MD +33 (0)1 40 83 68 52 frhr@coloplast.com

Locations
Belgium
Hôpital Erasme Not yet recruiting
Brussels, Belgium
Principal Investigator: Thierry Roumeguere, MD            
Universitair Ziekenhuis Gent Not yet recruiting
Gent, Belgium
Principal Investigator: Karel Everaert, MD            
France
Groupe Hospitalo Universitaire Carémeau Not yet recruiting
Nîmes, France
Principal Investigator: Pierre Costa, MD            
Hôpital de la Pitié-Salpêtrière Not yet recruiting
Paris, France
Principal Investigator: Emmanuel Chartier-Kastler, MD            
Germany
Universitätsklinikum Schleswig-Holstein Not yet recruiting
Kiel, Germany
Principal Investigator: Carsten M Naumann, MD            
Heilig Geist Krankenhaus Not yet recruiting
Köln, Germany
Principal Investigator: Moritz Braun, MD            
Italy
Hospital Santa Maria della Misericordia Not yet recruiting
Udine, Italy
Principal Investigator: Simone Crivellaro, MD            
Netherlands
Leiden University Medical Center Not yet recruiting
Leiden, Netherlands
Principal Investigator: Henk Elzevier, MD            
Spain
Fundacio Puigvert - Universitat Autonoma de Barcelona Not yet recruiting
Barcelona, Spain
Principal Investigator: ARANO, MD            
United Kingdom
Guy's Hospital Not yet recruiting
London, United Kingdom
Principal Investigator: Paul Hegarty, MD            
Sponsors and Collaborators
Coloplast A/S
  More Information

No publications provided

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: May 28, 2012
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
Urinary Incontinence, Stress
Urination Disorders
 Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013