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Virtue® European Study
This study is ongoing, but not recruiting participants.
Sponsor:
Coloplast A/S
Information provided by (Responsible Party):
Coloplast A/S
ClinicalTrials.gov Identifier:
NCT01608789
First received: May 28, 2012
Last updated: April 22, 2015
Last verified: April 2015
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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: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Virtue® Male Sling European Study |
Resource links provided by NLM:
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 ]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 ]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 ]
- 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 ]
- Subject reported improvement measured by the PGI-I [ Time Frame: 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 ]
- Patient satisfaction questionaire [ Time Frame: 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.
| Enrollment: | 123 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | February 2018 |
| Estimated Primary Completion Date: | February 2016 (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 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01608789
Please refer to this study by its ClinicalTrials.gov identifier: NCT01608789
Locations
| Belgium | |
| Hôpital Erasme | |
| Brussels, Belgium | |
| Universitair Ziekenhuis Gent | |
| Gent, Belgium | |
| France | |
| Centre Hospitalier Universitaire Henri Mondor | |
| Créteil, France | |
| Groupe Hospitalo Universitaire Carémeau | |
| Nîmes, France | |
| Hôpital de la Pitié-Salpêtrière | |
| Paris, France | |
| Germany | |
| Universitätsklinikum Schleswig-Holstein | |
| Kiel, Germany | |
| Heilig Geist Krankenhaus | |
| Köln, Germany | |
| Ireland | |
| Mater Private Hospital | |
| Dublin, Ireland | |
| Italy | |
| Istituto europeo di Oncologia | |
| Milan, Italy | |
| Hospital Santa Maria della Misericordia | |
| Udine, Italy | |
| Netherlands | |
| Leiden University Medical Center | |
| Leiden, Netherlands | |
| Spain | |
| Fundacio Puigvert - Universitat Autonoma de Barcelona | |
| Barcelona, Spain | |
| Hospital Universitario Puerta del Mar | |
| Cádiz, Spain | |
| United Kingdom | |
| Guy's Hospital | |
| London, United Kingdom | |
Sponsors and Collaborators
Coloplast A/S
More Information
| 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: | April 22, 2015 |
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 |
ClinicalTrials.gov processed this record on June 23, 2017