Virtue® European Study

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Stress Urinary Incontinence	Device: Virtue® Male Sling	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	123 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Virtue® Male Sling European Study
Actual Study Start Date :	August 27, 2012
Actual Primary Completion Date :	June 28, 2016
Estimated Study Completion Date :	June 5, 2018

Arms and Interventions

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Arm	Intervention/treatment
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).

Outcome Measures

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Primary Outcome Measures :

1. Improvement of urinary incontinence based on 24-hour pad test [ Time Frame: 1 year ]
   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.
2. Safety of the device characterized by reported adverse events [ Time Frame: 1 year ]
   Safety of the device, including the implant procedure.

Secondary Outcome Measures :

1. Improvement of urinary incontinence based on 24-hour pad test [ Time Frame: Baseline, 1 month, 3 months, 6 months, 2 years, 3 years ]
2. 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 ]
3. Subject reported improvement measured by the PGI-I [ Time Frame: 1 month, 3 months, 6 months, 1 year, 2 years, 3 years ]
4. 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 ]
5. Patient satisfaction questionaire [ Time Frame: 1 month, 3 months, 6 months, 1 year, 2 years, 3 years ]
6. Safety of the device characterized by reported adverse events [ Time Frame: Intraoperative, 1 month, 3 months, 6 months, 2 years, 3 years ]
   Safety of the device, including the implant procedure.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes 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

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Locations

Belgium
Hôpital Erasme
Brussels, Belgium, 1070
Universitair Ziekenhuis Gent
Gent, Belgium, 9000
France
Centre Hospitalier Universitaire Henri Mondor
Créteil, France, 94010
Groupe Hospitalo Universitaire Carémeau
Nîmes, France, 30029
Hôpital de la Pitié-Salpêtrière
Paris, France, 75651
Germany
Universitätsklinikum Schleswig-Holstein
Kiel, Germany, 24105
Heilig Geist Krankenhaus
Köln, Germany, 50737
Ireland
Mater Private Hospital
Dublin, Ireland
Italy
Istituto europeo di Oncologia
Milan, Italy, 20141
Hospital Santa Maria della Misericordia
Udine, Italy, 33100
Netherlands
Leiden University Medical Center
Leiden, Netherlands, 23000
Spain
Fundacio Puigvert - Universitat Autonoma de Barcelona
Barcelona, Spain, 0825
Hospital Universitario Puerta del Mar
Cádiz, Spain, 11009
United Kingdom
Guy's Hospital
London, United Kingdom

Sponsors and Collaborators

Coloplast A/S

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Coloplast A/S
ClinicalTrials.gov Identifier:	NCT01608789 History of Changes
Other Study ID Numbers:	SU012
First Posted:	May 31, 2012
Last Update Posted:	January 25, 2018
Last Verified:	January 2018

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