The purpose of this study is to monitor the use of Virtue® Male Sling in a real world population and collect medical data on effectiveness and to monitor safety of Virtue® at 12 and 36 months post device implantation in men with post-prostatectomy urinary incontinence.
Implanted with the Virtue® Male Sling System
Refuses to be included in the survey or that their medical data will be used for research purposes.
Indication for the Virtue® Male Sling System implantation is not for the treatment of male urinary incontinence
Patient implanted with Virtue® Male Sling System to treat post-prostatectomy urinary incontience
Case-only
Prospective
Virtue male sling
DeviceThe Coloplast 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 in-trinsic sphincter deficiency (ISD). The sling is manufactured from polypropylene and is sold for single use only. The device is a quadratic sling and consists of a knitted monofilament polypropylene mesh. The body of the device provides surface area for supporting the bulbous urethra.
Patient Global Impression of Improvement (PGI-I)
PGI-I is a validated questionnaire that collects the patient's impression of improvement after the surgery. Among this 7-point scale (very much better, much better, a little better, no change, a little worse, much worse and very much worse), we ask the patients to check the one number that best decribes how their urinary tract condition is now, compared with how it's was before the surgery. Patients who score little or much or very much better will be considered a treatment success. We measure the percentage of patient who describe the treatment success
Adverse events
Adverse events are any untoward medical occurrence, unintended disease or injury or any untoward clinical signs in subjects. Adverse events will be categorized according to relatedness to device or procedure, severity, and frequency. At 12-months, we measure the percentage of patients without any device related severe or serious adverse events.
Pad weight testing
Percent change in weight from baseline in 24-hour or 1-hour pad weight test
Uroflowmetry
Uroflowmetry including a measure of voided volume and the peak urine flow rate (Qmax) will be collected up to 12-months. Data will be used to determine the presence of urinary obstruction. If the Qmax is considered normal by the physician after the procedure it is not necessary to collect these data at subsequent follow-up visits.
Post-void residual (PVR) volume
PVR volume will be collected pre-and post implant procedure up to 12-months. If the PVR volume is considered normal by the physician after the procedure it is not necessary to collect these data at subsequent follow-up visits.
Pad Use
The number of pads used per day will be collected. Patients will be considered to be pad free if they report never wearing pads or wear pads just for a sense of security.
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