Virtue® Male Incontinence Sling Study

• Sponsor: Coloplast A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00856778
• Collaborator: (none)
• Enrollment: 98
• Locations: 11
• Arm: 1
• Duration (Months): 24
• Patients Per Site: 8.9
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Stress Urinary Incontinence	Device: Virtue® Male Incontinence Sling	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 98 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Virtue® Male Incontinence Sling Study
• Study Start Date: Jan 1, 2009
• Actual Primary Completion Date: Jan 1, 2011
• Actual Study Completion Date: Jan 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Other: Virtue® Male Sling Subjects implanted with Virtue® Male Sling	Device: Virtue® Male Incontinence 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.

Outcome Measures

Primary Outcome Measures

1. Patient Satisfaction Using the Patient Global Impression of Improvement (PGI-I) [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".

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

Secondary Outcome Measures

1. Assess Change in Subject Satisfaction Through ICIQ [Baseline]

   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.

2. Assess Change in Subject Satisfaction Through ICIQ [12 months post implant]

   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.

3. Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Bother [Baseline]

   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.

4. Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Bother [12 months post implant]

   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.

5. Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Function [Baseline]

   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.

6. Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Function [12 months post implant]

   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.

7. Assess Change in Pad Use [Baseline]

   Patients reported the average number of pads used in a 24 hour period over the 4 weeks prior to the assessment.

8. Assess Change in Pad Use [12 months post-implant]

9. Physician Questionnaire - Virtue® Surgical Procedure Was Straightforward [At implant]

10. Physician Questionnaire - Virtue® Procedure Was as Easy as Competitive Therapies [At implant]

11. Physician Questionnaire - Virtue® Was Easy to Position Over the Bulbous Urethra [At implant]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kaiser Permanente	Los Angeles	California	United States	90027
2	Stanford University Medical Center	Stanford	California	United States	94305
3	Winter Park Urology Associates	Orlando	Florida	United States	32803
4	Northeast Indiana Research	Fort Wayne	Indiana	United States	46825
5	Wayne State University	Dearborn	Michigan	United States	48124
6	NYU Urology Associates	New York	New York	United States	10016
7	McKay Urology	Charlotte	North Carolina	United States	28207
8	University of Texas-M.D. Anderson Cancer Center	Houston	Texas	United States	77210
9	Sunybrook Health Sciences Centre	Toronto	Ontario	Canada	4N 3M5
10	Mortimer S Davis Jewish General Hospital	Montreal	Quebec	Canada	H3T 1E2
11	CHUS Hopital Fleurimont	Sherbrooke	Quebec	Canada	J1H 5N44

Sponsors and Collaborators

• Coloplast A/S

Investigators

• Principal Investigator: Craig Comiter, MD, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Coloplast A/S
• ClinicalTrials.gov Identifier: NCT00856778
• Other Study ID Numbers: CP001SU
• First Posted: Mar 6, 2009
• Last Update Posted: Apr 29, 2014
• Last Verified: Apr 1, 2014

• Keywords provided by Coloplast A/S: Male sling; stress urinary incontinence; urinary incontinence
• Additional relevant MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress

Study Results

Participant Flow

Arm/Group Title	Subjects Implanted With Virtue® Male Sling
Arm/Group Description	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.
Period Title: Overall Study
STARTED	98
COMPLETED	74
NOT COMPLETED	24

Baseline Characteristics

Arm/Group Title	Subjects Implanted With Virtue® Male Sling
Arm/Group Description	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.
Overall Participants	98
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	44 44.9%
>=65 years	54 55.1%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	67.0 (8.5)
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	98 100%
Region of Enrollment (participants) [Number]
United States	62 63.3%
Canada	36 36.7%

Outcome Measures

1. Primary Outcome

Title	Patient Satisfaction Using the Patient Global Impression of Improvement (PGI-I)
Description	Patient satisfaction using the Patient Global Impression of Improvement (PGI-I. Definition of Success: >50% responding "very much better" or "much better".
Time Frame	12 months post implant

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Subjects Implanted With Virtue® Male Sling
Arm/Group Description	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.
Measure Participants	74
Number (95% Confidence Interval) [% of subjects successful]	41.9

2. Primary Outcome

Title	Assess Change in 24-hour Pad Weight. Definition of Success: >50% With Outcome of Improved, Much Improved, Very Much Improved, or Cured (Dry).
Description	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".
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Subjects Implanted With Virtue® Male Sling
Arm/Group Description	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.
Measure Participants	71
Number (95% Confidence Interval) [% of subjects successful]	62.0

3. Secondary Outcome

Title	Assess Change in Subject Satisfaction Through ICIQ
Description	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.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

There are 95 subjects with outcome 3 (ICIQ at baseline). Of the 98 subjects implanted, 3 are missing the baseline ICIQ assessment.

Arm/Group Title	Subjects Implanted With Virtue® Male Sling
Arm/Group Description	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.
Measure Participants	95
Mean (Standard Deviation) [units on a scale - ICIQ Score]	16.6 (3.2)

4. Secondary Outcome

Title	Assess Change in Subject Satisfaction Through ICIQ
Description	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.
Time Frame	12 months post implant

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Subjects Implanted With Virtue® Male Sling
Arm/Group Description	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.
Measure Participants	73
Mean (Standard Deviation) [units on a scale - ICIQ Score]	12.0 (6.1)

5. Secondary Outcome

Title	Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Bother
Description	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.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

There are 97 subjects with outcome 5 (Urinary bother at baseline). Of the 98 subjects implanted, 3 are missing the baseline Urinary Bother assessment.

Arm/Group Title	Subjects Implanted With Virtue® Male Sling
Arm/Group Description	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.
Measure Participants	97
Mean (Standard Deviation) [units on a scale]	13.7 (20.7)

6. Secondary Outcome

Title	Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Bother
Description	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.
Time Frame	12 months post implant

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Subjects Implanted With Virtue® Male Sling
Arm/Group Description	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.
Measure Participants	74
Mean (Standard Deviation) [units on a scale]	36.5 (34.9)

7. Secondary Outcome

Title	Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Function
Description	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.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

There are 97 subjects with outcome 7 (Urinary function at baseline). Of the 98 subjects implanted, 1 is missing the baseline Urinary Function assessment.

Arm/Group Title	Subjects Implanted With Virtue® Male Sling
Arm/Group Description	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.
Measure Participants	97
Mean (Standard Deviation) [units on a scale]	17.1 (12.6)

8. Secondary Outcome

Title	Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Function
Description	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.
Time Frame	12 months post implant

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Subjects Implanted With Virtue® Male Sling
Arm/Group Description	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.
Measure Participants	74
Mean (Standard Deviation) [units on a scale]	37.1 (28.2)

9. Secondary Outcome

Title	Assess Change in Pad Use
Description	Patients reported the average number of pads used in a 24 hour period over the 4 weeks prior to the assessment.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

There are 97 subjects with outcome 9 (baseline pad use). Of the 98 subjects implanted, one is missing the baseline assessment of pad use.

Arm/Group Title	Subjects Implanted With Virtue® Male Sling
Arm/Group Description	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.
Measure Participants	97
Mean (Standard Deviation) [pads/24 hours]	4.1 (3.6)

10. Secondary Outcome

Title	Assess Change in Pad Use
Time Frame	12 months post-implant

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Subjects Implanted With Virtue® Male Sling
Arm/Group Description	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.
Measure Participants	74
Mean (Standard Deviation) [pads/24 hours]	2.4 (2.1)

11. Secondary Outcome

Title	Physician Questionnaire - Virtue® Surgical Procedure Was Straightforward
Time Frame	At implant

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Subjects Implanted With Virtue® Male Sling
Arm/Group Description	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.
Measure Participants	98
Strongly disagree	4.1
Somewhat disagree	6.1
Neutral	3.1
Somewhat agree	24.5
Strongly agree	62.2

12. Secondary Outcome

Title	Physician Questionnaire - Virtue® Procedure Was as Easy as Competitive Therapies
Time Frame	At implant

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Subjects Implanted With Virtue® Male Sling
Arm/Group Description	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.
Measure Participants	98
Strongly disagree	3.1
Somewhat disagree	13.3
Neutral	10.2
Somewhat agree	9.2
Strongly agree	64.3

13. Secondary Outcome

Title	Physician Questionnaire - Virtue® Was Easy to Position Over the Bulbous Urethra
Time Frame	At implant

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Subjects Implanted With Virtue® Male Sling
Arm/Group Description	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.
Measure Participants	98
Strongly disagree	3.1
Somewhat disagree	2.0
Neutral	3.1
Somewhat agree	30.6
Strongly agree	61.2

Adverse Events

Time Frame	12 months
Arm/Group Title	Subjects Implanted With Virtue® Male Sling
Arm/Group Description	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.
All Cause Mortality
	Subjects Implanted With Virtue® Male Sling
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Subjects Implanted With Virtue® Male Sling
	Affected / at Risk (%)	# Events
Total	2/98 (2%)
Surgical and medical procedures
Hematoma	1/98 (1%)	1
Urosepsis	1/98 (1%)	1
Other (Not Including Serious) Adverse Events
	Subjects Implanted With Virtue® Male Sling
	Affected / at Risk (%)	# Events
Total	26/98 (26.5%)
Surgical and medical procedures
Paresthesia (genital)	12/98 (12.2%)	12
Perineal pain	14/98 (14.3%)	14

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.