Stress Urinary IncontinenceNCT00856778

Virtue® Male Incontinence Sling Study

A study testing Virtue® Male Incontinence Sling in people with Stress Urinary Incontinence, run by Coloplast A/S at 11 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is a multi-center, global study that will assess the effectiveness and patient satisfaction of the male incontinence sling 12 months after implant as well as the safety profile of the product. 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 Incontinence Sling
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 98 participants
Where: 11 sitesin 2 countries
Study dates: Jan 2009to Jan 2011
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Male subject at least 18 yrs old with an estimated life expectancy of more than 5 years
Confirmed SUI (stress urinary incontinence) through medical history, urodynamics, and/or physical exam
Subject has completed urodynamics, uroflow, post-void residual and cystoscopy per protocol within 12 months prior to implant
Subject has intrinsic sphincter deficiency due to one of the following: post-TURP (trans-urethral resection of the prostate), simple open prostatectomy, radical prostatectomy completed at least 6 months prior to implantation date
Subject is willing to have the Virtue male sling implanted and is able and willing to completed all f/u visits and procedures as indicated in protocol
Subject agrees to the provisions of the study and has provided written informed consent as approved by the local ethics committee of the respective site

Who cannot join

Subject is unable or unwilling to sign the Informed Consent Form and/or comply with provisions of the study
Subject has active urogenital infection or active skin infection in region of surgery
Subject has serious bleeding disorders
Subject has incontinence due to neurogenic causes defined as multiple sclerosis, spinal cord/brain injury,CVA (cerebrovascular accident), detrusor-external sphincter dyssynergia, Parkinson's disease, or similar conditions
Subject has previous implant to treat SUI
Subject has undergone radiation, cryosurgery, or brachytherapy to treat prostate or other pelvic cancer with 6 months or is likely to undergo radiation therapy within the next 6 months
Subject has active urethral or bladder neck stricture disease requiring continued treatment
Subject has urge predominant incontinence

Trial locations and contacts

11 sites in 2 countries.

Country

City, postcode or hospital

11 sites in 2 countries

United States8 sites

McKay Urology
Charlotte, North Carolina, 28207
Wayne State University
Dearborn, Michigan, 48124
Northeast Indiana Research
Fort Wayne, Indiana, 46825
University of Texas-M.D. Anderson Cancer Center
Houston, Texas, 77210
Kaiser Permanente
Los Angeles, California, 90027
NYU Urology Associates
New York, New York, 10016
Winter Park Urology Associates
Orlando, Florida, 32803
Stanford University Medical Center
Stanford, California, 94305

Other trials in United States

Canada3 sites

Mortimer S Davis Jewish General Hospital
Montreal, Quebec, H3T 1E2
CHUS Hopital Fleurimont
Sherbrooke, Quebec, J1H 5N44
Sunybrook Health Sciences Centre
Toronto, Ontario, 4N 3M5

Other trials in Canada

About this study

Conditions: Stress Urinary Incontinence
Being tested: Virtue® Male Incontinence Sling
Keywords: Male sling, 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.

Virtue® Male Incontinence SlingDevice
The VIRTUE® male sling is a Class II, implantable, sub-urethral, permanent, non-absorbable support sling indicated for the surgical treatment of male SUI resulting from intrinsic sphincter deficiency. The sling is manufactured from polypropylene and is sold for single use only.

Study groups in NCT00856778
Study group	Role	What they receive
Virtue® Male Sling	Other	Subjects implanted with Virtue® Male Sling Receives: Device: Virtue® Male Incontinence Sling

What is being measured

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

Patient Satisfaction Using the Patient Global Impression of Improvement (PGI-I)
Patient satisfaction using the Patient Global Impression of Improvement (PGI-I. Definition of Success: >50% responding "very much better" or "much better".
Measured: 12 months post implant
Assess Change in 24-hour Pad Weight. Definition of Success: >50% With Outcome of Improved, Much Improved, Very Much Improved, or Cured (Dry).
Endpoint definition: Improved = 25-49% reduction of pad weight, Much Improved = 50-89% reduction of pad weight, Very Much Improved = <12 grams or 90% reduction in pad weight, Cured = Dry. Definition of Success: >50% responding "very much better" or "much better".
Measured: 12 months

Secondary outcomes (11)

Assess Change in Subject Satisfaction Through ICIQ
The ICIQ-UI Short Form (International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form) is a brief self-assessment instrument applicable to all incontinent patients worldwide that measures the severity of urinary incontinence. The score ranges from 0 to 21 with higher number indicative of worse Urinary Incontinence severity.
Measured: Baseline
Assess Change in Subject Satisfaction Through ICIQ
The ICIQ-UI Short Form (International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form) is a brief self-assessment instrument applicable to all incontinent patients worldwide that measures the severity of urinary incontinence. The score ranges from 0 to 21 with higher number indicative of worse Urinary Incontinence severity.
Measured: 12 months post implant
Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Bother
The UCLA-RAND Incontinence Index is from a section within the RAND 36-item Health Survey v2 (SF-36 v2) and UCLA Prostate Cancer Index and measures a patient's urinary habits over the 4 weeks prior to questionnaire completion and consists of 6 questions. Two scores are produced, the Urinary Bother and Urinary Function scores. The Urinary Bother score ranges from 0 to 100 with lower scores indicating worse symptoms of urinary bother. The Urinary Function score ranges from 0 to 100 with lower scores indicating worse urinary function.
Measured: Baseline
Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Bother
The UCLA-RAND Incontinence Index is from a section within the RAND 36-item Health Survey v2 (SF-36 v2) and UCLA Prostate Cancer Index and measures a patient's urinary habits over the 4 weeks prior to questionnaire completion and consists of 6 questions. Two scores are produced, the Urinary Bother and Urinary Function scores. The Urinary Bother score ranges from 0 to 100 with lower scores indicating worse symptoms of urinary bother. The Urinary Function score ranges from 0 to 100 with lower scores indicating worse urinary function.
Measured: 12 months post implant
Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Function
The UCLA-RAND Incontinence Index is from a section within the RAND 36-item Health Survey v2 (SF-36 v2) and UCLA Prostate Cancer Index and measures a patient's urinary habits over the 4 weeks prior to questionnaire completion and consists of 6 questions. Two scores are produced, the Urinary Bother and Urinary Function scores. The Urinary Bother score ranges from 0 to 100 with lower scores indicating worse symptoms of urinary bother. The Urinary Function score ranges from 0 to 100 with lower scores indicating worse urinary function.
Measured: Baseline
Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Function
The UCLA-RAND Incontinence Index is from a section within the RAND 36-item Health Survey v2 (SF-36 v2) and UCLA Prostate Cancer Index and measures a patient's urinary habits over the 4 weeks prior to questionnaire completion and consists of 6 questions. Two scores are produced, the Urinary Bother and Urinary Function scores. The Urinary Bother score ranges from 0 to 100 with lower scores indicating worse symptoms of urinary bother. The Urinary Function score ranges from 0 to 100 with lower scores indicating worse urinary function.
Measured: 12 months post implant
Assess Change in Pad Use
Patients reported the average number of pads used in a 24 hour period over the 4 weeks prior to the assessment.
Measured: Baseline
Assess Change in Pad Use
Measured: 12 months post-implant
Physician Questionnaire - Virtue® Surgical Procedure Was Straightforward
Measured: At implant
Physician Questionnaire - Virtue® Procedure Was as Easy as Competitive Therapies
Measured: At implant
Physician Questionnaire - Virtue® Was Easy to Position Over the Bulbous Urethra
Measured: At implant

Timeline

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

Jan 2009Jan 2011

First posted6 Mar 2009 (estimated)
Study startJan 2009
Primary completionJan 2011
Study completionJan 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: 98 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00856778
Sponsor's protocol ID: CP001SU
Status last verified: Apr 2014
First submitted: 5 Mar 2009
Last updated: 29 Apr 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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

RecruitingObservational study
Standardized 4D Transperineal Ultrasound Assessment of Urethrovesical Junction Mobility After Vaginal Laser Treatment for Stress Urinary Incontinence.
Urinary Incontinence , Stress, Laser Therapy
Not yet recruiting
Feasibility of Resisted Expiratory Muscle Training for Females Assigned at Birth With Stress Urinary Incontinence: A Pilot Study
Stress Urinary Incontinence
RecruitingPhase 2
Surface Electrical Stimulation for Urinary Incontinence in Men Treated for Prostate Cancer
Urinary Urge Incontinence, Stress Urinary Incontinence
RecruitingPhase 4
Prophylactic Antibiotics for Outpatient Urethral Bulking
Urinary Tract Infections, 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

All Stress Urinary Incontinence trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Virtue® Male Incontinence Sling Study
ClinicalTrials.gov ID: NCT00856778
Acronym / sponsor ID: CP001SU
Conditions: Stress Urinary Incontinence
Keywords: Male sling, stress urinary incontinence, urinary incontinence
Study type: Interventional
Recruitment status: Completed
Enrolment: 98 participants (actual)
Lead sponsor: Coloplast A/SIndustry (pharma, biotech, devices)
Study start: Jan 2009
Primary completion: Jan 2011 (actual)
Study completion: Jan 2011 (actual)
First posted: 6 Mar 2009 (estimated)
Results: Posted 14 Apr 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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	Other	Device: Virtue® Male Incontinence SlingSubjects implanted with 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 (6 listed)

Male subject at least 18 yrs old with an estimated life expectancy of more than 5 years
Confirmed SUI (stress urinary incontinence) through medical history, urodynamics, and/or physical exam
Subject has completed urodynamics, uroflow, post-void residual and cystoscopy per protocol within 12 months prior to implant
Subject has intrinsic sphincter deficiency due to one of the following: post-TURP (trans-urethral resection of the prostate), simple open prostatectomy, radical prostatectomy completed at least 6 months prior to implantation date
Subject is willing to have the Virtue male sling implanted and is able and willing to completed all f/u visits and procedures as indicated in protocol

Key exclusion criteria (8 listed)

Subject is unable or unwilling to sign the Informed Consent Form and/or comply with provisions of the study
Subject has active urogenital infection or active skin infection in region of surgery
Subject has serious bleeding disorders
Subject has incontinence due to neurogenic causes defined as multiple sclerosis, spinal cord/brain injury,CVA (cerebrovascular accident), detrusor-external sphincter dyssynergia, Parkinson's disease, or similar conditions
Subject has previous implant to treat SUI

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 Incontinence SlingThe VIRTUE® male sling is a Class II, implantable, sub-urethral, permanent, non-absorbable support sling indicated for the surgical treatment of male SUI resulting from intrinsic sphincter deficiency. The sling is manufactured from polypropylene and is sold for single use only.	Device	Virtue® Male Sling

Primary outcome

Patient Satisfaction Using the Patient Global Impression of Improvement (PGI-I)
Time frame: 12 months post implant
Patient satisfaction using the Patient Global Impression of Improvement (PGI-I. Definition of Success: >50% responding "very much better" or "much better".
Assess Change in 24-hour Pad Weight. Definition of Success: >50% With Outcome of Improved, Much Improved, Very Much Improved, or Cured (Dry).
Time frame: 12 months
Endpoint definition: Improved = 25-49% reduction of pad weight, Much Improved = 50-89% reduction of pad weight, Very Much Improved = <12 grams or 90% reduction in pad weight, Cured = Dry. Definition of Success: >50% responding "very much better" or "much better".

11 secondary outcomes

Assess Change in Subject Satisfaction Through ICIQ
Time frame: Baseline
Assess Change in Subject Satisfaction Through ICIQ
Time frame: 12 months post implant
Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Bother
Time frame: Baseline
Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Bother
Time frame: 12 months post implant
Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Function
Time frame: Baseline
Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Function
Time frame: 12 months post implant
Assess Change in Pad Use
Time frame: Baseline
Assess Change in Pad Use
Time frame: 12 months post-implant
Physician Questionnaire - Virtue® Surgical Procedure Was Straightforward
Time frame: At implant
Physician Questionnaire - Virtue® Procedure Was as Easy as Competitive Therapies
Time frame: At implant
Physician Questionnaire - Virtue® Was Easy to Position Over the Bulbous Urethra
Time frame: At implant

Results and safety

Results posted to the registry on 14 Apr 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Subjects Implanted With Virtue® Male Sling	98	74

Primary outcome: Patient Satisfaction Using the Patient Global Impression of Improvement (PGI-I)

Time frame: 12 months post implant. Number (95% Confidence Interval). Unit: % of subjects successful

Measure	Subjects Implanted With Virtue® Male Sling n = 74
Value	41.9 (30.5 to 53.9)

Population analysed: The study was not fully enrolled and therefore underpowered for the planned analyses.

Primary outcome: Assess Change in 24-hour Pad Weight. Definition of Success: >50% With Outcome of Improved, Much Improved, Very Much Improved, or Cured (Dry).

Time frame: 12 months. Number (95% Confidence Interval). Unit: % of subjects successful

Measure	Subjects Implanted With Virtue® Male Sling n = 71
Value	62.0 (49.7 to 73.2)

Population analysed: The study was not fully enrolled and therefore underpowered for the planned analyses. There are 71 subjects with outcome 2 (pad weight endpoint). Of the 74 with 12 months follow-up, 3 are missing the pad weight improvement assessment.

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Subjects Implanted With Virtue® Male Sling	2 of 98 (2%)	26 of 98 (26.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Stress Urinary Incontinence

RecruitingObservational study
Standardized 4D Transperineal Ultrasound Assessment of Urethrovesical Junction Mobility After Vaginal Laser Treatment for Stress Urinary Incontinence.
Urinary Incontinence , Stress, Laser Therapy
Not yet recruiting
Feasibility of Resisted Expiratory Muscle Training for Females Assigned at Birth With Stress Urinary Incontinence: A Pilot Study
Stress Urinary Incontinence
RecruitingPhase 2
Surface Electrical Stimulation for Urinary Incontinence in Men Treated for Prostate Cancer
Urinary Urge Incontinence, Stress Urinary Incontinence
RecruitingPhase 4
Prophylactic Antibiotics for Outpatient Urethral Bulking
Urinary Tract Infections, 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

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 principal investigator

Stanford University

11 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Virtue® Male Incontinence Sling in people with Stress Urinary Incontinence, run by Coloplast A/S at 11 sites in 2 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 6 inclusion and 8 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 29 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States, Canada. 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?

Yes. Results are posted in the registry (first posted 14 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Patient Satisfaction Using the Patient Global Impression of Improvement (PGI-I) (time frame: 12 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 NCT00856778.

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 29 Apr 2014.