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Virtue® Male Incontinence Sling Study

Primary Purpose

Stress Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Virtue® Male Incontinence Sling
Sponsored by
Coloplast A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring Male sling, stress urinary incontinence, urinary incontinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Kaiser Permanente
  • Stanford University Medical Center
  • Winter Park Urology Associates
  • Northeast Indiana Research
  • Wayne State University
  • NYU Urology Associates
  • McKay Urology
  • University of Texas-M.D. Anderson Cancer Center
  • Sunybrook Health Sciences Centre
  • Mortimer S Davis Jewish General Hospital
  • CHUS Hopital Fleurimont

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Virtue® Male Sling

Arm Description

Subjects implanted with Virtue® Male Sling

Outcomes

Primary Outcome Measures

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".
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".

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
Assess Change in Pad Use
Physician Questionnaire - Virtue® Surgical Procedure Was Straightforward
Physician Questionnaire - Virtue® Procedure Was as Easy as Competitive Therapies
Physician Questionnaire - Virtue® Was Easy to Position Over the Bulbous Urethra

Full Information

First Posted
March 5, 2009
Last Updated
April 11, 2014
Sponsor
Coloplast A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00856778
Brief Title
Virtue® Male Incontinence Sling Study
Official Title
Virtue® Male Incontinence Sling Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coloplast A/S

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
Keywords
Male sling, stress urinary incontinence, urinary incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtue® Male Sling
Arm Type
Other
Arm Description
Subjects implanted with Virtue® Male Sling
Intervention Type
Device
Intervention Name(s)
Virtue® Male Incontinence Sling
Intervention 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.
Primary Outcome Measure Information:
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
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
Secondary Outcome Measure Information:
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
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
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
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
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
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
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
Title
Assess Change in Pad Use
Time Frame
12 months post-implant
Title
Physician Questionnaire - Virtue® Surgical Procedure Was Straightforward
Time Frame
At implant
Title
Physician Questionnaire - Virtue® Procedure Was as Easy as Competitive Therapies
Time Frame
At implant
Title
Physician Questionnaire - Virtue® Was Easy to Position Over the Bulbous Urethra
Time Frame
At implant

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Craig Comiter, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Winter Park Urology Associates
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Northeast Indiana Research
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46825
Country
United States
Facility Name
Wayne State University
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48124
Country
United States
Facility Name
NYU Urology Associates
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
McKay Urology
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
University of Texas-M.D. Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77210
Country
United States
Facility Name
Sunybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
4N 3M5
Country
Canada
Facility Name
Mortimer S Davis Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
CHUS Hopital Fleurimont
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N44
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Virtue® Male Incontinence Sling Study

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