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
Qualifiers
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 design
Treatments tested in this trial
- AMS-800
- ADVANCE/ADVANCEXP
- VIRTUE
- INVANCE