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Virtue Male Incontinence Sling Study

18 Years
Not Enrolling
Stress Urinary Incontinence

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Trial Information

Virtue Male Incontinence Sling Study

Inclusion Criteria:

- Male subject at least 18 yrs old with an estimated life expectancy of more than 5

- Confirmed SUI through medical history, uroldynamics, 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: psot-TURP,
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 seriuos bleeding idsorders

- Subject has incontinence due to neurogenic causes defined as multiple sclerosis,
spinal cord/brain injury,CVA, detrusor-external sphincter dyssynergia, Parkinson's
disease, or similar conditions

- Subject has previous implant to treat SUI

- Subject has undergone radiation, cryosurgery, or brachy therapy 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

- Subject has urge predominant incontinence

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Patient satisfaction using the Patient Global Impression of Improvement (PGI-I) and assess change in 24 hour pad weight.

Outcome Time Frame:

12 months post implant

Safety Issue:


Principal Investigator

Craig Comiter, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University


United States: Institutional Review Board

Study ID:




Start Date:

January 2009

Completion Date:

January 2011

Related Keywords:

  • Stress Urinary Incontinence
  • Male sling
  • stress urinary incontinence
  • urinary incontinence
  • Urinary Incontinence
  • Urinary Incontinence, Stress



Stanford University Medical CenterStanford, California  94305-5408
Wayne State UniversityDetroit, Michigan  48202
Northeast Indiana ResearchFort Wayne, Indiana  46804-4128
Winter Park Urology AssociatesOrlando, Florida  32803
Mckay UrologyCharlotte,, North Carolina  28204
Kaiser PermanenteSacramento, California  
NYU Urology AssociatesNew York, New York  10016
University of Texas-M.D. Anderson Cancer CenterHouston, Texas  77210