Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Coloplast A/S
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
