Stress Urinary IncontinenceNCT01608789
Virtue® European Study
A study testing Virtue® Male Sling in people with Stress Urinary Incontinence, run by Coloplast A/S at 14 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Virtue® Male Sling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 14 sitesin 8 countries
- Study dates
- 27 Aug 2012to 11 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
14 sites in 8 countries.
14 sites in 8 countries
France3 sites
Centre Hospitalier Universitaire Henri Mondor
Créteil, 94010
Groupe Hospitalo Universitaire Carémeau
Nîmes, 30029
Hôpital de la Pitié-Salpêtrière
Paris, 75651
Belgium2 sites
Hôpital Erasme
Brussels, 1070
Universitair Ziekenhuis Gent
Ghent, 9000
Germany2 sites
Heilig Geist Krankenhaus
Cologne, 50737
Universitätsklinikum Schleswig-Holstein
Kiel, 24105
Italy2 sites
Istituto europeo di Oncologia
Milan, 20141
Hospital Santa Maria della Misericordia
Udine, 33100
Spain2 sites
Fundacio Puigvert - Universitat Autonoma de Barcelona
Barcelona, 0825
Hospital Universitario Puerta del Mar
Cadiz, 11009
About this study
Official title: 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.
Read the 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.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Virtue® Male Sling
- Keywords
- Male sling, Stress Urinary Incontinence, Urination Disorders, Urologic Diseases
- Medical subject headings
- Urinary Incontinence, Stress, Urination Disorders, Urologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtue® Male SlingDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Virtue® Male Sling | Experimental | Patient implanted Virtue® Male Sling Receives: Device: Virtue® Male Sling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Safety of the device characterized by reported adverse events
Safety of the device, including the implant procedure.
Measured: 1 year
Secondary outcomes (6)
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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: Intraoperative, 1 month, 3 months, 6 months, 2 years, 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2012 (estimated)
- Study start27 Aug 2012
- Primary completion28 Jun 2016
- Study completion11 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01608789
- Sponsor's protocol ID
- SU012
- Status last verified
- Jun 2020
- First submitted
- 28 May 2012
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtue® Male Sling European Study
- ClinicalTrials.gov ID
- NCT01608789
- Acronym / sponsor ID
- SU012
- Conditions
- Stress Urinary Incontinence
- Keywords
- Male sling, Stress Urinary Incontinence, Urination Disorders, Urologic Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- 27 Aug 2012 (actual)
- Primary completion
- 28 Jun 2016 (actual)
- Study completion
- 11 Jun 2018 (actual)
- First posted
- 31 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtue® Male Sling | Experimental | Device: Virtue® Male SlingPatient implanted Virtue® Male Sling |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The subject has an estimated life expectancy of more than 5 years
Key exclusion criteria (14 listed)
- The subject is unable or unwilling to comply with all follow-up requirements according to the study protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtue® Male SlingThe 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). | Device | Virtue® Male Sling |
Primary outcome
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.
6 secondary outcomes
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
Improvement of urinary incontinence based on 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtue® Male Sling in people with Stress Urinary Incontinence, run by Coloplast A/S at 14 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in France, Belgium, Germany, Italy, Spain and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of urinary incontinence based on 24-hour pad test (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2020.