Stress Urinary IncontinenceNCT01170728

Virtue® Male Sling Fixation Study

An observational study of Stress Urinary Incontinence, run by Coloplast A/S at 10 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

This study is a multi-center study that will assess the efficacy and safety of suture fixation of the Virtue® Male Sling. 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?: Coloplast Virtue® Male Sling
Type of treatment: Medical device
How many people: 44 participants
Where: 10 sitesUnited States
Study dates: Jul 2010to Jun 2014
Phase: Observational
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

Study population: Subjects satisfying inclusion and exclusion criteria were enrolled.

Who may be able to join

Male subject at least 18 years of age with an estimated life expectancy of 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 completed post-void residual per protocol within 6 weeks prior to implant
The subject has completed cystoscopy as per protocol within 12 months prior to implant
The subject has intrinsic sphincter deficiency due to one of the following: post-transurethral resection of the prostate (TURP), simple open prostatectomy, or radical prostatectomy completed at least 6 months prior to implantation date
The subject has failed at least two non-invasive therapies, eg. pelvic/Kegel exercises, behavioral modification or biofeedback for at least 6 months

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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 the protocol
The subject has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the local ethics committee of the respective site

Who cannot join

The subject is unable or unwilling to sign the informed consent form (ICF)and/or 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
The subject has serious bleeding disorders
The subject has incontinence due to neurogenic causes defined as multiple sclerosis, spinal cord/brain injury, cerebrovascular accident (CVA), detrusor-external sphincter dyssynergia, Parkinson's disease, or similar condition
The subject had a previous implant to treat stress urinary incontinence
The subject has undergone radiation, cryosurgery, or brachy therapy to treat prostate or other pelvic cancer within 6 months

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The subject is likely to undergo radiation therapy within the next 6 months
The subject has active urethral or bladder neck stricture disease requiring continued treatment
The subject has urge predominant incontinence
The subject has an atonic bladder or a postvoid residual (PVR) greater than or equal to 150 milliliters (mL)
The subject has a condition or disorder likely to require future transurethral procedure
The subject is enrolled in a concurrent clinical study of any treatment (drug or device) that could affect continence function without sponsor's approval
The subject is deemed unfit for male sling implantation or participation in a research protocol as determined by attending physician

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

United States10 sites

Urology Associates of North Texas
Arlington, Texas, 76017
Midtown Urology
Atlanta, Georgia, 30308
McKay Urology
Charlotte, North Carolina, 28207
University of Chicago Medical Center
Chicago, Illinois, 60637
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
NYU Urology Associates
New York, New York, 10016
Winter Park Urology
Orlando, Florida, 32803
Mayo Clinic Arizona
Phoenix, Arizona, 85054
Kaiser Permanente
San Diego, California, 92154
Stanford University Medical Center
Stanford, California, 94305

Other trials in United States

About this study

This study is a multi-center study that will assess the efficacy and safety of suture fixation of the Virtue® Male Sling.

Conditions: Stress Urinary Incontinence
Being tested: Coloplast Virtue® Male Sling
Keywords: Male Sling, Fixation, Stress Urinary Incontinence, Urinary incontinence
Medical subject headings: Urinary Incontinence, Stress, Urinary Incontinence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Coloplast Virtue® Male SlingDevice
The Virtue Male sling is a class II single use 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). The device consists of a knitted monofilament polypropylene mesh which provides surface area for supporting the bulbous urethra. The four arms are covered with polyethylene sleeves with braided polyester sutures attached at the end of the mesh arms providing proper attachment to the introducer for positioning of the sling. The single use introducer allows for implanting both the trans-obturator arms and pre-pubic arms of the mesh sling.

Study groups in NCT01170728
Study group	Role	What they receive
Virtue® Male Sling		Device: Coloplast Virtue® Male Sling Receives: Device: Coloplast Virtue® Male Sling

What is being measured

The primary outcome is the main question the study is designed to answer.

Improvement of incontinence
Measured: 3 months post implant
Safety of the device characterized by reported adverse events
Measured: 3 months

Secondary outcomes (2)

To characterize incontinence severity at various time points
Measured: 24 months
To evaluate patient quality of life at specified time points
Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2010Jun 2014

First posted27 Jul 2010 (estimated)
Study startJul 2010
Primary completionJun 2014
Study completionJun 2014

Why it stopped: The study has been terminated due to lack of subject enrollment.

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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01170728
Sponsor's protocol ID: CP008SU
Status last verified: Aug 2015
First submitted: 26 Jul 2010
Last updated: 24 Aug 2015
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Comparing the Effect of Two Types of Pelvic Floor Muscle Stimulation Devices to Improve Symptoms of Urinary Incontinence in Women.
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Effect of High-Intensity Focused Electromagnetic (HIFEM) Technology in the Treatment of SUI in Chinese Men Undergone Robotic Radical Prostatectomy
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All Stress Urinary Incontinence trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Virtue® Male Sling Fixation Study
ClinicalTrials.gov ID: NCT01170728
Acronym / sponsor ID: CP008SU
Conditions: Stress Urinary Incontinence
Keywords: Male Sling, Fixation, Stress Urinary Incontinence, Urinary incontinence
Study type: Observational
Recruitment status: TerminatedReason stopped: The study has been terminated due to lack of subject enrollment.
Enrolment: 44 participants (actual)
Lead sponsor: Coloplast A/SIndustry (pharma, biotech, devices)
Study start: Jul 2010
Primary completion: Jun 2014 (actual)
Study completion: Jun 2014 (actual)
First posted: 27 Jul 2010 (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 multi-center study that will assess the efficacy and safety of suture fixation of the Virtue® Male Sling.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Virtue® Male Sling	–	Device: Coloplast Virtue® Male SlingDevice: Coloplast Virtue® Male Sling

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Subjects satisfying inclusion and exclusion criteria were enrolled.

Key inclusion criteria (9 listed)

Male subject at least 18 years of age with an estimated life expectancy of 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 completed post-void residual per protocol within 6 weeks prior to implant
The subject has completed cystoscopy as per protocol within 12 months prior to implant
The subject has intrinsic sphincter deficiency due to one of the following: post-transurethral resection of the prostate (TURP), simple open prostatectomy, or radical prostatectomy completed at least 6 months prior to implantation date

Key exclusion criteria (13 listed)

The subject is unable or unwilling to sign the informed consent form (ICF)and/or 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
The subject has serious bleeding disorders
The subject has incontinence due to neurogenic causes defined as multiple sclerosis, spinal cord/brain injury, cerebrovascular accident (CVA), detrusor-external sphincter dyssynergia, Parkinson's disease, or similar condition
The subject had a previous implant to treat stress urinary incontinence

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
Coloplast Virtue® Male SlingThe Virtue Male sling is a class II single use 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). The device consists of a knitted monofilament polypropylene mesh which provides surface area for supporting the bulbous urethra. The four arms are covered with polyethylene sleeves with braided polyester sutures attached at the end of the mesh arms providing proper attachment to the introducer for positioning of the sling. The single use introducer allows for implanting both the trans-obturator arms and pre-pubic arms of the mesh sling.	Device	Virtue® Male Sling

Primary outcome

Improvement of incontinence
Time frame: 3 months post implant
Safety of the device characterized by reported adverse events
Time frame: 3 months

2 secondary outcomes

To characterize incontinence severity at various time points
Time frame: 24 months
To evaluate patient quality of life at specified time points
Time frame: 24 months

Results and safety

The study was stopped early (reason given: The study has been terminated due to lack of subject enrollment.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2015.

Related trials for Stress Urinary Incontinence

Not yet recruiting
Anterior Bridge-Preserving Versus Conventional Early Apical Release in Bipolar Enucleation of the Prostate
Benign Prostatic Hyperplasia, Benign Prostatic Obstruction
Not yet recruiting
Anterior Bridge-Preserving Versus Conventional Early Apical Release During Holmium Laser Enucleation of the Prostate
Benign Prostatic Hyperplasia, Benign Prostatic Obstruction
Recruiting
Comparing the Effect of Two Types of Pelvic Floor Muscle Stimulation Devices to Improve Symptoms of Urinary Incontinence in Women.
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Active, not recruiting
A Study to Assess the Safety and Effectiveness of the UrOActive® Artificial Urinary sPHincter (AUS)
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Recruiting
Effect of High-Intensity Focused Electromagnetic (HIFEM) Technology in the Treatment of SUI in Chinese Men Undergone Robotic Radical Prostatectomy
Urinary Incontinence , Stress, Prostatectomy

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.

Craig Comiter, MD study chair

Stanford University

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Stress Urinary Incontinence, run by Coloplast A/S at 10 sites in United States.

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 9 inclusion and 13 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: stopped early, as of the sponsor's last update on 24 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. 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 was stopped early (reason given: The study has been terminated due to lack of subject enrollment.). Results are not available in the source record.

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 incontinence (time frame: 3 months post implant). 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?

On the ClinicalTrials.gov record for NCT01170728.

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 24 Aug 2015.