Clinical trial NCT01170728: Virtue® Male Sling Fixation Study
Official title: Virtue® Male Sling Fixation Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Stress Urinary Incontinence
Keywords: Male Sling
Fixation
Stress Urinary Incontinence
Urinary incontinence
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2010-07-27
Enrollment: 44
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects satisfying inclusion and exclusion criteria were enrolled.

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


Eligibility criteria: 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

Primary outcomes:
measure: Improvement of incontinence
timeFrame: 3 months post implant
measure: Safety of the device characterized by reported adverse events
timeFrame: 3 months
Secondary outcomes:
measure: To characterize incontinence severity at various time points
timeFrame: 24 months
measure: To evaluate patient quality of life at specified time points
timeFrame: 24 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: San Diego
country: United States
facility: Kaiser Permanente
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Orlando
country: United States
facility: Winter Park Urology
state: Florida
city: Atlanta
country: United States
facility: Midtown Urology
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: New York
country: United States
facility: NYU Urology Associates
state: New York
city: Charlotte
country: United States
facility: McKay Urology
state: North Carolina
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: Arlington
country: United States
facility: Urology Associates of North Texas
state: Texas
Study officials:
affiliation: Stanford University
name: Craig Comiter, MD
role: STUDY_CHAIR
References: