Virtue® European Study

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: Completed
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Device: Virtue® Male Sling

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: Interventional
• Enrollment (Actual): 123
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1070
    • Hôpital 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
    • Universitätsklinikum 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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	1 year
Safety of the device characterized by reported adverse events	Safety of the device, including the implant procedure.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline, 1 month, 3 months, 6 months, 2 years, 3 years
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.	baseline,1 month, 3 months, 6 months, 1 year, 2 years and 3 years
Improvement of urinary incontinence based on PGI-I	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	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	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	Safety of the device, including the implant procedure.	Intraoperative, 1 month, 3 months, 6 months, 2 years, 3 years

Collaborators and Investigators

• Sponsor: Coloplast A/S

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2012
• Primary Completion (Actual): June 28, 2016
• Study Completion (Actual): June 11, 2018

Study Registration Dates

• First Submitted: May 28, 2012
• First Submitted That Met QC Criteria: May 28, 2012
• First Posted (Estimate): May 31, 2012

Study Record Updates

• Last Update Posted (Actual): June 11, 2020
• Last Update Submitted That Met QC Criteria: June 9, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Stress Urinary Incontinence; Urologic Diseases; Urination Disorders; Male sling
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: SU012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO