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Virtue® Male Incontinence Sling Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S
ClinicalTrials.gov Identifier:
NCT00856778
First received: March 5, 2009
Last updated: April 11, 2014
Last verified: April 2014
  Purpose

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 Intervention
Stress Urinary Incontinence
Device: Virtue® Male Incontinence Sling

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Virtue® Male Incontinence Sling Study

Resource links provided by NLM:


Further study details as provided by Coloplast A/S:

Primary Outcome Measures:
  • Patient Satisfaction Using the Patient Global Impression of Improvement (PGI-I) [ Time Frame: 12 months post implant ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months post implant ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months post implant ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months post implant ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months post-implant ] [ Designated as safety issue: No ]
  • Physician Questionnaire - Virtue® Surgical Procedure Was Straightforward [ Time Frame: At implant ] [ Designated as safety issue: No ]
  • Physician Questionnaire - Virtue® Procedure Was as Easy as Competitive Therapies [ Time Frame: At implant ] [ Designated as safety issue: No ]
  • Physician Questionnaire - Virtue® Was Easy to Position Over the Bulbous Urethra [ Time Frame: At implant ] [ Designated as safety issue: No ]

Enrollment: 98
Study Start Date: January 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00856778

Locations
United States, California
Kaiser Permanente
Los Angeles, California, United States, 90027
Stanford University Medical Center
Stanford, California, United States, 94305
United States, Florida
Winter Park Urology Associates
Orlando, Florida, United States, 32803
United States, Indiana
Northeast Indiana Research
Fort Wayne, Indiana, United States, 46825
United States, Michigan
Wayne State University
Dearborn, Michigan, United States, 48124
United States, New York
NYU Urology Associates
New York, New York, United States, 10016
United States, North Carolina
McKay Urology
Charlotte, North Carolina, United States, 28207
United States, Texas
University of Texas-M.D. Anderson Cancer Center
Houston, Texas, United States, 77210
Canada, Ontario
Sunybrook Health Sciences Centre
Toronto, Ontario, Canada, 4N 3M5
Canada, Quebec
Mortimer S Davis Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
CHUS Hopital Fleurimont
Sherbrooke, Quebec, Canada, J1H 5N44
Sponsors and Collaborators
Coloplast A/S
Investigators
Principal Investigator: Craig Comiter, MD Stanford University
  More Information

No publications provided

Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT00856778     History of Changes
Other Study ID Numbers: CP001SU
Study First Received: March 5, 2009
Results First Received: September 27, 2013
Last Updated: April 11, 2014
Health Authority: United States: Institutional Review Board
Canada: Health Canada
Netherlands: Dutch Health Care Inspectorate
Italy: Ministry of Health
Denmark: Danish Medicines Agency

Keywords provided by Coloplast A/S:
Male sling
stress urinary incontinence
urinary incontinence

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Lower Urinary Tract Symptoms
Signs and Symptoms
Urination Disorders
Urologic Diseases
Urological Manifestations

ClinicalTrials.gov processed this record on November 24, 2014