A 3 Years Naturalistic Cohort Survey Of Virtue® Male Sling System For Male Stress Urinary Incontinence

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 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.

Percent change in weight from baseline in 24-hour or 1-hour pad weight test

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.

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.

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.

The ICIQ-UI Short Form is a self-administred questionnaire to evaluate the frequency, severity, and impact on quality of life of urinary incontinence. Question 1 asked, "How often do you leak urine?" Subjects were instructed to select among "none" (0), "about once a week or less often" (1), "2 or 3 times a week" (2), "about once a day" (3), "several times a day" (4), and "all the time" (5). Question 2 asked, "How much urine do you usually leak (whether you wear protection or not)?" Patients responded with "none" (0), "a small amount" (2), "a moderate amount" (4) or "a large amount (6). Question 3 asked, "Overall, how much does leaking urine interfere with your everyday life?" Participants chose a number from 0 (not at all) to 10 (a great deal). Questions 1, 2 and 3 are summed to compute the total ICIQ SF score. The total score range is then a minimum of 0 to a maximum of 21. The mean score, absolute and relative change compared to baseline will be measure

This non-validated questionnaire provides additional information concerning patient satisfaction. The survey consists of two questions: How satisfied are you with your surgery?. Among 5 point-scale (very satisfied, satisfied, not satisfied-not dissatisfied, dissatisfied, very dissatisfied), patient check the one item that best describes the subject satisfaction. We measure the percentage the patients who very satisfied and satisfied. The patient answer the question "Do you recommend this operation to a friend?" by yes or no. We measure the percentage the patients who answer "yes".

The I-QoL is a validated survey questionnaire with 22 items that are scored on a 5-point Likert scale. The I-QOL and its subscale scores are computed by adding each item's response, subtracting the lowest possible score and dividing that sum by the possible raw score range. The scores are then transformed to have a range from 0 (maximum problem) to 100 (no problem at all). The mean score, absolute and relative change compared to baseline