About this trial
Stress urinary incontinence is a significant potential source of morbidity after radical prostatectomy or radiation therapy for prostate cancer. At present, artificial urinary sphincter remains the preferred therapeutic option. However, this technique is not free from complications. In an attempt to avoid such complications, male sling has been suggested for use in patients with mild degrees of stress incontinence.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The subject has agreed to be treated with the male Incontinence surgery devices
The subject is willing and able to give valid informed consent.
The subject is > 18 years of age.
The subject has confirmed stress urinary incontinence for at least 12 months after prostatectomy or radiotherapy.
Disqualifiers
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 unstable bladder neck stricture disease
The subject has Neurogenic bladder condition that is not treatable or controllable by pharmacological or alternative methods.
Trial population
Patients with stress urianry incontinence undergoing male sling or artificial urinary sphincter after prostatectomy or radiation therapy for prostate cancer
Trial design
Cohort
Prospective
Treatments tested in this trial
AMS-800
Procedure/SurgeryArtificial urianry sphincter
ADVANCE/ADVANCEXP
Procedure/SurgeryMale sling
VIRTUE
Procedure/SurgeryMale sling
INVANCE
Procedure/SurgeryMale sling
Treatment groups
Trial outcomes
Primary outcomes
Success rate
Cure is defined as no pad use
Secondary outcomes
Continence improvement
Assessed by means of the 24-Hour Pad Weight test
Lower tract urinary symptoms modification after male surgery incontinence
Assessed with IPSS questionaires
Quality of Life in patients with male surgery incontinence
Assessed with "International Consultation on Incontinence Questionnaire -- Short Form (ICIQ-SF)" questionaires
Sponsors and contacts
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