Virtue® Male Sling Fixation Study

Stress Urinary Incontinence Clinical Trial

Official title:

Virtue® Male Sling Fixation Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01170728
• Other study ID #: CP008SU
• Status: Terminated
• Phase: N/A
• First received: July 26, 2010
• Last updated: August 20, 2015
• Start date: July 2010
• Est. completion date: June 2014

Study information

• Verified date: August 2015
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 44
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

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.

Locations

Country	Name	City	State
United States	Urology Associates of North Texas	Arlington	Texas
United States	Midtown Urology	Atlanta	Georgia
United States	McKay Urology	Charlotte	North Carolina
United States	University of Chicago Medical Center	Chicago	Illinois
United States	Carolina Urologic Research Center	Myrtle Beach	South Carolina
United States	NYU Urology Associates	New York	New York
United States	Winter Park Urology	Orlando	Florida
United States	Mayo Clinic Arizona	Phoenix	Arizona
United States	Kaiser Permanente	San Diego	California
United States	Stanford University Medical Center	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of incontinence		3 months post implant	No
Primary	Safety of the device characterized by reported adverse events		3 months	Yes
Secondary	To characterize incontinence severity at various time points		24 months	No
Secondary	To evaluate patient quality of life at specified time points		24 months	No