This study is a prospective, single arm, non-randomized, multi-center clinical study that will be conducted in Europe. It is designed to assess efficacy and safety of the Virtue® Male Sling in post-prostatectomy urinary incontinence.
This study is a prospective, single arm, non-randomized, multi-center clinical study that will be conducted at up to thirteen centers in Europe. It is designed to assess efficacy and safety of the Virtue® Male Sling. One hundred and twenty-one subjects, satisfying criteria for selection, will be implanted with no more than 15 implanted per site. The study's primary end point will be evaluated at 12 months with continued data collection through 36 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
123
The Coloplast Virtue® Male Sling is a Class II, implantable, sub-urethral, permanent, non-absorbable support sling indicated for the surgical treatment of male stress urinary incontinence (SUI) resulting from intrinsic sphincter deficiency (ISD).
Hôpital Erasme
Brussels, Belgium
Universitair Ziekenhuis Gent
Ghent, Belgium
Centre Hospitalier Universitaire Henri Mondor
Créteil, France
Improvement of urinary incontinence based on 24-hour pad test
The primary effectiveness end point will be improvement in pad weight defined as at least a 50% reduction in 24-hour pad weight from baseline to 12-months.
Time frame: 1 year
Safety of the device characterized by reported adverse events
Safety of the device, including the implant procedure.
Time frame: 1 year
Improvement of urinary incontinence based on 24-hour pad test
24 hour pad weight tests will be administered at baseline, 1, 3, 6, 12, 24 and 36 months and the difference reported. Outcomes reported will include mean paired change from baseline as well as the proportion or patients improving by at least 50% from baseline
Time frame: Baseline, 1 month, 3 months, 6 months, 2 years, 3 years
Improvement of urinary incontinence based on number of pad used
Number and types of pads used will be collected at baseline,1, 3, 6, 12, 24 and 36 months and the difference reported.
Time frame: baseline,1 month, 3 months, 6 months, 1 year, 2 years and 3 years
Improvement of urinary incontinence based on PGI-I
Patient global Impression of improvement
Time frame: 1 month, 3 months, 6 months, 1 year, 2 years, 3 years
Assessment of the frequency, severity and impact on quality of life of urinary incontinence based on ICIQ-UI short form
Base on International Consultation on Incontinence questionnaire-Urinary Incontinence short-form
Time frame: baseline, 1 months, 3 months, 6 months, 1 year, 2 years and 3 years
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Groupe Hospitalo Universitaire Carémeau
Nîmes, France
Hôpital de la Pitié-Salpêtrière
Paris, France
Heilig Geist Krankenhaus
Cologne, Germany
Universitätsklinikum Schleswig-Holstein
Kiel, Germany
Mater Private Hospital
Dublin, Ireland
Istituto europeo di Oncologia
Milan, Italy
Hospital Santa Maria della Misericordia
Udine, Italy
...and 4 more locations
Patient satisfaction questionaire
the patient reported level of satisfaction in implantation sling procedure.
Time frame: 1 month, 3 months, 6 months, 1 year, 2 years, 3 years
Safety of the device characterized by reported adverse events
Safety of the device, including the implant procedure.
Time frame: Intraoperative, 1 month, 3 months, 6 months, 2 years, 3 years