Focus of the Report: Implantation of the ProACT device for the treatment of adult men with post-prostate surgery urinary incontinence (UI).
Technology Description: The ProACT system is a medical implantable device that consists of 2 sets of urethral balloons connected to titanium volume adjustment ports via tubing. During ProACT device implantation, a minimally invasive surgical procedure, a combined trocar and sheath system are used to guide the balloons up past the pelvic floor to the bladder neck. Once the balloons are filled to the ideal volume, proximal pressure is placed on the bladder neck, with the hope of sufficiently restoring bladder control. If patients still experience incontinence postoperatively, they can return for outpatient adjustments in which additional volume can be added to the balloons via the titanium ports that are implanted subcutaneously in the scrotum.
Controversy: For patients with post-prostate surgery UI that does not respond to 6 to 12 months of conservative treatment, artificial urinary sphincter (AUS) implantation is the standard surgical treatment option. AUS implantation is associated with an exceptionally high rate of efficacy, but an AUS is also unusable for patients without fine motor control, involves a somewhat invasive procedure, and is associated with high costs and frequent need for revision surgery. ProACT device implantation offers a less invasive alternative to an AUS that relies on passive bladder voiding instead of actively pumping to relieve the urethral sphincter. However, it remains to be seen whether the ProACT device can achieve comparable clinical dryness rates to an AUS.
Key Questions:
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Is the ProACT device effective in treating postsurgical urinary incontinence (UI) in men?
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How does the ProACT device compare with other treatments for postsurgical UI in men?
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Is the ProACT device safe?
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Have definitive patient selection criteria been identified for the ProACT device?
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