Virtue® European Study

June 9, 2020 updated by: Coloplast A/S

Virtue® Male Sling European Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
123

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Virtue® Male Sling
Patient implanted 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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
1 year
Safety of the device characterized by reported adverse events
Time Frame: 1 year
Safety of the device, including the implant procedure.
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Improvement of urinary incontinence based on 24-hour pad test
Time Frame: Baseline, 1 month, 3 months, 6 months, 2 years, 3 years
24 hour pad weight tests will be administered at baseline, 1, 3, 6, 12, 24 and 36 months and the difference reported. Outcomes reported will include mean paired change from baseline as well as the proportion or patients improving by at least 50% from baseline
Baseline, 1 month, 3 months, 6 months, 2 years, 3 years
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
Number and types of pads used will be collected at baseline,1, 3, 6, 12, 24 and 36 months and the difference reported.
baseline,1 month, 3 months, 6 months, 1 year, 2 years and 3 years
Improvement of urinary incontinence based on PGI-I
Time Frame: 1 month, 3 months, 6 months, 1 year, 2 years, 3 years
Patient global Impression of improvement
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
Time Frame: baseline, 1 months, 3 months, 6 months, 1 year, 2 years and 3 years
Base on International Consultation on Incontinence questionnaire-Urinary Incontinence short-form
baseline, 1 months, 3 months, 6 months, 1 year, 2 years and 3 years
Patient satisfaction questionaire
Time Frame: 1 month, 3 months, 6 months, 1 year, 2 years, 3 years
the patient reported level of satisfaction in implantation sling procedure.
1 month, 3 months, 6 months, 1 year, 2 years, 3 years
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.
Intraoperative, 1 month, 3 months, 6 months, 2 years, 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Coloplast A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 27, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 28, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 11, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 28, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 31, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 11, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SU012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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