Trial Outcomes & Findings for Virtue® Male Incontinence Sling Study (NCT NCT00856778)

NCT ID: NCT00856778

Last Updated: 2014-04-29

Results Overview

Patient satisfaction using the Patient Global Impression of Improvement (PGI-I. Definition of Success: \>50% responding "very much better" or "much better".

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 98 participants
• Primary outcome timeframe: 12 months post implant
• Results posted on: 2014-04-29

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	98
Overall Study COMPLETED	74
Overall Study NOT COMPLETED	24

Reasons for withdrawal

Measure	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.
Overall Study Adverse Event	7
Overall Study Withdrawal by Subject	10
Overall Study Study deviation	2
Overall Study Lost to Follow-up	5

Baseline Characteristics

Virtue® Male Incontinence Sling Study

Baseline characteristics by cohort

Measure	Subjects Implanted With Virtue® Male Sling n=98 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	44 Participants n=5 Participants
Age, Categorical >=65 years	54 Participants n=5 Participants
Age, Continuous	67.0 years STANDARD_DEVIATION 8.5 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	98 Participants n=5 Participants
Region of Enrollment United States	62 participants n=5 Participants
Region of Enrollment Canada	36 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months post implant

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

Patient satisfaction using the Patient Global Impression of Improvement (PGI-I. Definition of Success: >50% responding "very much better" or "much better".

Outcome measures

Measure	Subjects Implanted With Virtue® Male Sling n=74 Participants 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.
Patient Satisfaction Using the Patient Global Impression of Improvement (PGI-I)	41.9 % of subjects successful Interval 30.5 to 53.9

PRIMARY outcome

Timeframe: 12 months

Population: 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.

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".

Outcome measures

Measure	Subjects Implanted With Virtue® Male Sling n=71 Participants 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.
Assess Change in 24-hour Pad Weight. Definition of Success: >50% With Outcome of Improved, Much Improved, Very Much Improved, or Cured (Dry).	62.0 % of subjects successful Interval 49.7 to 73.2

SECONDARY outcome

Timeframe: Baseline

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

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.

Outcome measures

Measure	Subjects Implanted With Virtue® Male Sling n=95 Participants 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.
Assess Change in Subject Satisfaction Through ICIQ	16.6 units on a scale - ICIQ Score Standard Deviation 3.2

SECONDARY outcome

Timeframe: 12 months post implant

Population: 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.

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.

Outcome measures

Measure	Subjects Implanted With Virtue® Male Sling n=73 Participants 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.
Assess Change in Subject Satisfaction Through ICIQ	12.0 units on a scale - ICIQ Score Standard Deviation 6.1

SECONDARY outcome

Timeframe: Baseline

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

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.

Outcome measures

Measure	Subjects Implanted With Virtue® Male Sling n=97 Participants 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.
Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Bother	13.7 units on a scale Standard Deviation 20.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Subjects Implanted With Virtue® Male Sling n=74 Participants 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.
Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Bother	36.5 units on a scale Standard Deviation 34.9

SECONDARY outcome

Timeframe: Baseline

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

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.

Outcome measures

Measure	Subjects Implanted With Virtue® Male Sling n=97 Participants 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.
Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Function	17.1 units on a scale Standard Deviation 12.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Subjects Implanted With Virtue® Male Sling n=74 Participants 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.
Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Function	37.1 units on a scale Standard Deviation 28.2

SECONDARY outcome

Timeframe: Baseline

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

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

Outcome measures

Measure	Subjects Implanted With Virtue® Male Sling n=97 Participants 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.
Assess Change in Pad Use	4.1 pads/24 hours Standard Deviation 3.6

SECONDARY outcome

Timeframe: 12 months post-implant

Outcome measures

Measure	Subjects Implanted With Virtue® Male Sling n=74 Participants 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.
Assess Change in Pad Use	2.4 pads/24 hours Standard Deviation 2.1

SECONDARY outcome

Timeframe: At implant

Outcome measures

Measure	Subjects Implanted With Virtue® Male Sling n=98 Participants 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.
Physician Questionnaire - Virtue® Surgical Procedure Was Straightforward Strongly disagree	4.1 percentage of responses
Physician Questionnaire - Virtue® Surgical Procedure Was Straightforward Somewhat disagree	6.1 percentage of responses
Physician Questionnaire - Virtue® Surgical Procedure Was Straightforward Neutral	3.1 percentage of responses
Physician Questionnaire - Virtue® Surgical Procedure Was Straightforward Somewhat agree	24.5 percentage of responses
Physician Questionnaire - Virtue® Surgical Procedure Was Straightforward Strongly agree	62.2 percentage of responses

SECONDARY outcome

Timeframe: At implant

Outcome measures

Measure	Subjects Implanted With Virtue® Male Sling n=98 Participants 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.
Physician Questionnaire - Virtue® Procedure Was as Easy as Competitive Therapies Strongly disagree	3.1 percentage of responses
Physician Questionnaire - Virtue® Procedure Was as Easy as Competitive Therapies Somewhat disagree	13.3 percentage of responses
Physician Questionnaire - Virtue® Procedure Was as Easy as Competitive Therapies Neutral	10.2 percentage of responses
Physician Questionnaire - Virtue® Procedure Was as Easy as Competitive Therapies Somewhat agree	9.2 percentage of responses
Physician Questionnaire - Virtue® Procedure Was as Easy as Competitive Therapies Strongly agree	64.3 percentage of responses

SECONDARY outcome

Timeframe: At implant

Outcome measures

Measure	Subjects Implanted With Virtue® Male Sling n=98 Participants 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.
Physician Questionnaire - Virtue® Was Easy to Position Over the Bulbous Urethra Somewhat agree	30.6 percentage of responses
Physician Questionnaire - Virtue® Was Easy to Position Over the Bulbous Urethra Strongly disagree	3.1 percentage of responses
Physician Questionnaire - Virtue® Was Easy to Position Over the Bulbous Urethra Somewhat disagree	2.0 percentage of responses
Physician Questionnaire - Virtue® Was Easy to Position Over the Bulbous Urethra Neutral	3.1 percentage of responses
Physician Questionnaire - Virtue® Was Easy to Position Over the Bulbous Urethra Strongly agree	61.2 percentage of responses

Adverse Events

Subjects Implanted With Virtue® Male Sling

Serious events: 2 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Measure	Subjects Implanted With Virtue® Male Sling n=98 participants at risk 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.
Surgical and medical procedures Hematoma	1.0% 1/98 • Number of events 1 • 12 months
Surgical and medical procedures Urosepsis	1.0% 1/98 • Number of events 1 • 12 months

Other adverse events

Measure	Subjects Implanted With Virtue® Male Sling n=98 participants at risk 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.
Surgical and medical procedures Paresthesia (genital)	12.2% 12/98 • Number of events 12 • 12 months
Surgical and medical procedures Perineal pain	14.3% 14/98 • Number of events 14 • 12 months

Additional Information

Clinical Trial Manager

Coloplast Corp

Phone: 612-302-4990

Email: usdibe@coloplast.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place