Virtue® Male Sling Fixation Study

Sponsor

Coloplast A/S (Industry)

Overall Status

Terminated

CT.gov ID

NCT01170728

Collaborator

(none)

Enrollment

Locations

Duration (Months)

4.4

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is a multi-center study that will assess the efficacy and safety of suture fixation of the Virtue® Male Sling.

Condition or Disease	Intervention/Treatment	Phase
Stress Urinary Incontinence	Device: Coloplast Virtue® Male Sling

Study Design

Study Type:

Observational

Actual Enrollment :

44 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Virtue® Male Sling Fixation Study

Study Start Date :

Jul 1, 2010

Actual Primary Completion Date :

Jun 1, 2014

Actual Study Completion Date :

Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Virtue® Male Sling Device: Coloplast Virtue® Male Sling	Device: Coloplast Virtue® Male Sling The Virtue Male sling is a class II single use implantable sub-urethral, permanent, non-absorbable, support sling indicated for the surgical treatment of male stress urinary incontinence (SUI) resulting from intrinsic sphincter deficiency (ISD). The device consists of a knitted monofilament polypropylene mesh which provides surface area for supporting the bulbous urethra. The four arms are covered with polyethylene sleeves with braided polyester sutures attached at the end of the mesh arms providing proper attachment to the introducer for positioning of the sling. The single use introducer allows for implanting both the trans-obturator arms and pre-pubic arms of the mesh sling.

Arm

Intervention/Treatment

Virtue® Male Sling

Device: Coloplast Virtue® Male Sling

Device: Coloplast Virtue® Male Sling

The Virtue Male sling is a class II single use implantable sub-urethral, permanent, non-absorbable, support sling indicated for the surgical treatment of male stress urinary incontinence (SUI) resulting from intrinsic sphincter deficiency (ISD). The device consists of a knitted monofilament polypropylene mesh which provides surface area for supporting the bulbous urethra. The four arms are covered with polyethylene sleeves with braided polyester sutures attached at the end of the mesh arms providing proper attachment to the introducer for positioning of the sling. The single use introducer allows for implanting both the trans-obturator arms and pre-pubic arms of the mesh sling.

Outcome Measures

Primary Outcome Measures

Improvement of incontinence [3 months post implant]
Safety of the device characterized by reported adverse events [3 months]

Secondary Outcome Measures

To characterize incontinence severity at various time points [24 months]
To evaluate patient quality of life at specified time points [24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

Male subject at least 18 years of age with an estimated life expectancy of of more than 5 years
The subject has confirmed stress urinary incontinence (SUI) through medical history , urodynamics, and/or physical exam for at least 6 months
The subject has completed post-void residual per protocol within 6 weeks prior to implant
The subject has completed cystoscopy as per protocol within 12 months prior to implant
The subject has intrinsic sphincter deficiency due to one of the following: post-transurethral resection of the prostate (TURP), simple open prostatectomy, or radical prostatectomy completed at least 6 months prior to implantation date
The subject has failed at least two non-invasive therapies, eg. pelvic/Kegel exercises, behavioral modification or biofeedback for at least 6 months
The subject is willing to have the Virtue® Male Sling implanted
The subject is able and willing to complete all follow-up visits and procedures indicated in the protocol
The subject has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the local ethics committee of the respective site

Exclusion Criteria:

The subject is unable or unwilling to sign the informed consent form (ICF)and/or comply with all follow-up requirements according to the study protocol
The subject has an active urinary tract infection or active skin infection in region of surgery
The subject has serious bleeding disorders
The subject has incontinence due to neurogenic causes defined as multiple sclerosis, spinal cord/brain injury, cerebrovascular accident (CVA), detrusor-external sphincter dyssynergia, Parkinson's disease, or similar condition
The subject had a previous implant to treat stress urinary incontinence
The subject has undergone radiation, cryosurgery, or brachy therapy to treat prostate or other pelvic cancer within 6 months
The subject is likely to undergo radiation therapy within the next 6 months
The subject has active urethral or bladder neck stricture disease requiring continued treatment
The subject has urge predominant incontinence
The subject has an atonic bladder or a postvoid residual (PVR) greater than or equal to 150 milliliters (mL)
The subject has a condition or disorder likely to require future transurethral procedure
The subject is enrolled in a concurrent clinical study of any treatment (drug or device) that could affect continence function without sponsor's approval
The subject is deemed unfit for male sling implantation or participation in a research protocol as determined by attending physician

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic Arizona	Phoenix	Arizona	United States	85054
2	Kaiser Permanente	San Diego	California	United States	92154
3	Stanford University Medical Center	Stanford	California	United States	94305
4	Winter Park Urology	Orlando	Florida	United States	32803
5	Midtown Urology	Atlanta	Georgia	United States	30308
6	University of Chicago Medical Center	Chicago	Illinois	United States	60637
7	NYU Urology Associates	New York	New York	United States	10016
8	McKay Urology	Charlotte	North Carolina	United States	28207
9	Carolina Urologic Research Center	Myrtle Beach	South Carolina	United States	29572
10	Urology Associates of North Texas	Arlington	Texas	United States	76017