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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtue® Male Sling | Other | Subjects implanted with Virtue® Male Sling |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtue® Male Incontinence Sling | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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". | 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". | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Craig Comiter, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente | Los Angeles | California | 90027 | United States | ||
| Stanford University Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Subjects Implanted With Virtue® Male Sling | The Coloplast Virtue® Male Sling System is a permanent, synthetic suburethral sling, designed for the surgical treatment of male stress urinary incontinence (SUI). The Virtue® sling is made from knitted, monofilament polypropylene, and is for single-use only. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Subjects Implanted With Virtue® Male Sling | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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". | The study was not fully enrolled and therefore underpowered for the planned analyses. | Posted | Number | 95% Confidence Interval | % of subjects successful | 12 months post implant |
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Subjects Implanted With Virtue® Male Sling | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematoma | Surgical and medical procedures | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Paresthesia (genital) | Surgical and medical procedures | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Manager | Coloplast Corp | 612-302-4990 | usdibe@coloplast.com |
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| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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|
| 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. | 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. | 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. | 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. | 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. | 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. | Baseline |
| Assess Change in Pad Use | 12 months post-implant |
| Physician Questionnaire - Virtue® Surgical Procedure Was Straightforward | At implant |
| Physician Questionnaire - Virtue® Procedure Was as Easy as Competitive Therapies | At implant |
| Physician Questionnaire - Virtue® Was Easy to Position Over the Bulbous Urethra | At implant |
| Stanford |
| California |
| 94305 |
| United States |
| Winter Park Urology Associates | Orlando | Florida | 32803 | United States |
| Northeast Indiana Research | Fort Wayne | Indiana | 46825 | United States |
| Wayne State University | Dearborn | Michigan | 48124 | United States |
| NYU Urology Associates | New York | New York | 10016 | United States |
| McKay Urology | Charlotte | North Carolina | 28207 | United States |
| University of Texas-M.D. Anderson Cancer Center | Houston | Texas | 77210 | United States |
| Sunybrook Health Sciences Centre | Toronto | Ontario | 4N 3M5 | Canada |
| Mortimer S Davis Jewish General Hospital | Montreal | Quebec | H3T 1E2 | Canada |
| CHUS Hopital Fleurimont | Sherbrooke | Quebec | J1H 5N44 | Canada |
| Lost to Follow-up |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | 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". | 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. | Posted | Number | 95% Confidence Interval | % of subjects successful | 12 months |
|
|
|
| Secondary | 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. | There are 95 subjects with outcome 3 (ICIQ at baseline). Of the 98 subjects implanted, 3 are missing the baseline ICIQ assessment. | Posted | Mean | Standard Deviation | units on a scale - ICIQ Score | Baseline |
|
|
|
| Secondary | 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. | There are 73 subjects with outcome 4 (ICIQ at 12 months). Of the 74 subjects with 12 months follow-up, 1 is missing the 12 month ICIQ assessment. | Posted | Mean | Standard Deviation | units on a scale - ICIQ Score | 12 months post implant |
|
|
|
| Secondary | 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. | There are 97 subjects with outcome 5 (Urinary bother at baseline). Of the 98 subjects implanted, 3 are missing the baseline Urinary Bother assessment. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | 12 months post implant |
|
|
|
| Secondary | 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. | There are 97 subjects with outcome 7 (Urinary function at baseline). Of the 98 subjects implanted, 1 is missing the baseline Urinary Function assessment. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
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|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | 12 months post implant |
|
|
|
| Secondary | 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. | There are 97 subjects with outcome 9 (baseline pad use). Of the 98 subjects implanted, one is missing the baseline assessment of pad use. | Posted | Mean | Standard Deviation | pads/24 hours | Baseline |
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| Secondary | Assess Change in Pad Use | Posted | Mean | Standard Deviation | pads/24 hours | 12 months post-implant |
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| Secondary | Physician Questionnaire - Virtue® Surgical Procedure Was Straightforward | Posted | Number | percentage of responses | At implant |
|
|
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| Secondary | Physician Questionnaire - Virtue® Procedure Was as Easy as Competitive Therapies | Posted | Number | percentage of responses | At implant |
|
|
|
| Secondary | Physician Questionnaire - Virtue® Was Easy to Position Over the Bulbous Urethra | Posted | Number | percentage of responses | At implant |
|
|
|
| 2 |
| 98 |
| 26 |
| 98 |
| Urosepsis | Surgical and medical procedures | Systematic Assessment |
|
| Perineal pain | Surgical and medical procedures | Systematic Assessment |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Somewhat agree |
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| Strongly agree |
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| Somewhat agree |
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| Strongly agree |
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| Somewhat agree |
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| Strongly agree |
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