NCT00856778

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2009

Typical duration for not_applicable

Geographic Reach
2 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 6, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

April 14, 2014

Completed
Last Updated

April 29, 2014

Status Verified

April 1, 2014

Enrollment Period

2 years

First QC Date

March 5, 2009

Results QC Date

September 27, 2013

Last Update Submit

April 11, 2014

Conditions

Stress Urinary Incontinence

Keywords

Male slingstress urinary incontinenceurinary incontinence

Outcome Measures

Primary Outcomes (2)

  • 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".

    12 months post implant

  • 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".

    12 months

Secondary Outcomes (11)

  • Assess Change in Subject Satisfaction Through ICIQ

    Baseline

  • Assess Change in Subject Satisfaction Through ICIQ

    12 months post implant

  • Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Bother

    Baseline

  • Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Bother

    12 months post implant

  • Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Function

    Baseline

  • +6 more secondary outcomes

Study Arms (1)

Virtue® Male Sling

OTHER

Subjects implanted with Virtue® Male Sling

Device: Virtue® Male Incontinence Sling

Interventions

Virtue® Male Incontinence SlingDEVICE

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.

Virtue® Male Sling

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Kaiser Permanente

Los Angeles, California, 90027, United States

Location

Stanford University Medical Center

Stanford, California, 94305, United States

Location

Winter Park Urology Associates

Orlando, Florida, 32803, United States

Location

Northeast Indiana Research

Fort Wayne, Indiana, 46825, United States

Location

Wayne State University

Dearborn, Michigan, 48124, United States

Location

NYU Urology Associates

New York, New York, 10016, United States

Location

McKay Urology

Charlotte, North Carolina, 28207, United States

Location

University of Texas-M.D. Anderson Cancer Center

Houston, Texas, 77210, United States

Location

Sunybrook Health Sciences Centre

Toronto, Ontario, 4N 3M5, Canada

Location

Mortimer S Davis Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

CHUS Hopital Fleurimont

Sherbrooke, Quebec, J1H 5N44, Canada

Location

MeSH Terms

Conditions

Urinary Incontinence, StressUrinary Incontinence

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Clinical Trial Manager
Organization
Coloplast Corp
usdibe@coloplast.com
612-302-4990

Study Officials

  • Craig Comiter, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2009

First Posted

March 6, 2009

Study Start

January 1, 2009

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

April 29, 2014

Results First Posted

April 14, 2014

Record last verified: 2014-04

Locations

US(8)CA(3)