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Virtue® European Study

Primary Purpose

Stress Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Virtue® Male Sling
Sponsored by
Coloplast A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring Male sling, Stress Urinary Incontinence, Urination Disorders, Urologic Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Erasme
  • Universitair Ziekenhuis Gent
  • Centre Hospitalier Universitaire Henri Mondor
  • Groupe Hospitalo Universitaire Carémeau
  • Hôpital de la Pitié-Salpêtrière
  • Universitätsklinikum Schleswig-Holstein
  • Heilig Geist Krankenhaus
  • Mater Private Hospital
  • Istituto europeo di Oncologia
  • Hospital Santa Maria della Misericordia
  • Leiden University Medical Center
  • Fundacio Puigvert - Universitat Autonoma de Barcelona
  • Hospital Universitario Puerta del Mar
  • Guy's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Virtue® Male Sling

Arm Description

Patient implanted Virtue® Male Sling

Outcomes

Primary Outcome Measures

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.
Safety of the device characterized by reported adverse events
Safety of the device, including the implant procedure.

Secondary Outcome Measures

Improvement of urinary incontinence based on 24-hour pad test
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
Improvement of urinary incontinence based on number of pad used
Number and types of pads used will be collected at baseline,1, 3, 6, 12, 24 and 36 months and the difference reported.
Improvement of urinary incontinence based on PGI-I
Patient global Impression of improvement
Assessment of the frequency, severity and impact on quality of life of urinary incontinence based on ICIQ-UI short form
Base on International Consultation on Incontinence questionnaire-Urinary Incontinence short-form
Patient satisfaction questionaire
the patient reported level of satisfaction in implantation sling procedure.
Safety of the device characterized by reported adverse events
Safety of the device, including the implant procedure.

Full Information

First Posted
May 28, 2012
Last Updated
June 9, 2020
Sponsor
Coloplast A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01608789
Brief Title
Virtue® European Study
Official Title
Virtue® Male Sling European Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
August 27, 2012 (Actual)
Primary Completion Date
June 28, 2016 (Actual)
Study Completion Date
June 11, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coloplast A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
Keywords
Male sling, Stress Urinary Incontinence, Urination Disorders, Urologic Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
123 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtue® Male Sling
Arm Type
Experimental
Arm Description
Patient implanted Virtue® Male Sling
Intervention Type
Device
Intervention Name(s)
Virtue® Male Sling
Intervention Description
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).
Primary Outcome Measure Information:
Title
Improvement of urinary incontinence based on 24-hour pad test
Description
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.
Time Frame
1 year
Title
Safety of the device characterized by reported adverse events
Description
Safety of the device, including the implant procedure.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Improvement of urinary incontinence based on 24-hour pad test
Description
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
Time Frame
Baseline, 1 month, 3 months, 6 months, 2 years, 3 years
Title
Improvement of urinary incontinence based on number of pad used
Description
Number and types of pads used will be collected at baseline,1, 3, 6, 12, 24 and 36 months and the difference reported.
Time Frame
baseline,1 month, 3 months, 6 months, 1 year, 2 years and 3 years
Title
Improvement of urinary incontinence based on PGI-I
Description
Patient global Impression of improvement
Time Frame
1 month, 3 months, 6 months, 1 year, 2 years, 3 years
Title
Assessment of the frequency, severity and impact on quality of life of urinary incontinence based on ICIQ-UI short form
Description
Base on International Consultation on Incontinence questionnaire-Urinary Incontinence short-form
Time Frame
baseline, 1 months, 3 months, 6 months, 1 year, 2 years and 3 years
Title
Patient satisfaction questionaire
Description
the patient reported level of satisfaction in implantation sling procedure.
Time Frame
1 month, 3 months, 6 months, 1 year, 2 years, 3 years
Title
Safety of the device characterized by reported adverse events
Description
Safety of the device, including the implant procedure.
Time Frame
Intraoperative, 1 month, 3 months, 6 months, 2 years, 3 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Hôpital Erasme
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Centre Hospitalier Universitaire Henri Mondor
City
Créteil
ZIP/Postal Code
94010
Country
France
Facility Name
Groupe Hospitalo Universitaire Carémeau
City
Nîmes
ZIP/Postal Code
30029
Country
France
Facility Name
Hôpital de la Pitié-Salpêtrière
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
Universitätsklinikum Schleswig-Holstein
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Heilig Geist Krankenhaus
City
Köln
ZIP/Postal Code
50737
Country
Germany
Facility Name
Mater Private Hospital
City
Dublin
Country
Ireland
Facility Name
Istituto europeo di Oncologia
City
Milan
ZIP/Postal Code
20141
Country
Italy
Facility Name
Hospital Santa Maria della Misericordia
City
Udine
ZIP/Postal Code
33100
Country
Italy
Facility Name
Leiden University Medical Center
City
Leiden
ZIP/Postal Code
23000
Country
Netherlands
Facility Name
Fundacio Puigvert - Universitat Autonoma de Barcelona
City
Barcelona
ZIP/Postal Code
0825
Country
Spain
Facility Name
Hospital Universitario Puerta del Mar
City
Cádiz
ZIP/Postal Code
11009
Country
Spain
Facility Name
Guy's Hospital
City
London
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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Virtue® European Study

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