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.
This project will be launched after the first introduction of Virtue® Male Sling in Europe. This study is a multicenter prospective, non-interventional (i.e. naturalistic) post-marketing clinical follow up of men with urinary incontinence implanted with Virtue® Male Sling System by urologists who are experienced in the device. The patient will be followed for 12 months in routine real world clinical practice except for administration of subject questionnaire(s). Routine visits will be performed approximately at baseline (preoperative and implantation period), between 1 and 3 months (immediate post-operative period) and 12 months. Then questionnaires will be mailed annually during 2 additional years.
Study Type
OBSERVATIONAL
Enrollment
130
The 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.
CHU Angers
Angers, France
RECRUITINGJean Minjoz Hospital
Besançon, France
RECRUITINGPatient 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
Time frame: 12 months
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.
Time frame: 12 months
Pad weight testing
Percent change in weight from baseline in 24-hour or 1-hour pad weight test
Time frame: Baseline, 8 weeks and 12 months
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.
Time frame: Baseline, 8 weeks, 12 months
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.
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CHU de Caen
Caen, France
RECRUITINGCentre Hospitalier Chalon Sur Saône William Morey
Chalon-sur-Saône, France
RECRUITINGGroupe Hospitalier Henri Mendor
Créteil, France
TERMINATEDClaude Huriez Hospital
Lille, France
WITHDRAWNClinique Mutualiste de la Porte de l'Orient
Lorient, France
COMPLETEDEdouard Herriot Hospital
Lyon, France
COMPLETEDClinique de l'Esperance
Mougins, France
COMPLETEDCHU Carémeau
Nîmes, France
RECRUITING...and 3 more locations
Time frame: Baseline, 8 weeks, 12 months
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.
Time frame: Baseline, 8 weeks, 12, 24, 36 months
International Consultation on Incontinence Questionnaire (ICIQ-UI)
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
Time frame: Baseline, 8 weeks, 12, 24, 36 months
Subject global satisfaction questionnaire
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".
Time frame: 8 weeks, 12, 24, 36 months
Incontinence quality of life questionnaire (I-QoL)
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
Time frame: Baseline, 8 weeks, 12, 24, 36 months