Trial to Assess the Efficacy of the Comfort Plug™in Preventing Urinary Incontinence (COMFORT STUDY)

This is a first-in-human, device assessment, feasibility study to assess the safety, effectiveness, comfort and usability of the prototype Comfort Plug™ for controlling urinary incontinence in male subjects. No drug treatment will be administered.

Inclusion criteria

• Male 18 years of age or older
• At least 6 months post radical prostatectomy for localized prostate cancer
• Cystoscopic evaluation of the lower urinary tract within 12 months of screening
• Eastern Cooperative Oncology Group (ECOG) 0 or 1 performance status
• Evidence of moderate to severe urinary incontinence as assessed by the investigator, requiring protective garments or pads
• Post-surgical Prostate Specific Antigen (PSA) <0.04

Exclusion criteria

• Inability to insert the Comfort Plug™ into his own urethra and remove it
• History of significant incontinence prior to radical prostatectomy
• Evidence of incomplete bladder emptying post radical prostatectomy
• Recurrent , refractory bacteruria
• Urethral stricture disease.
• History of meatal stenosis or phimosis
• History of any other malignancy except basal cell skin cancer
• Planned radiotherapy for post prostatectomy residual disease within the next 90 days
• Evidence of neurogenic bladder dysfunction
• Multiple sclerosis or previous spinal cord trauma/pathology resulting in any neurologic deficit that, in the opinion of the investigator, might compromise the outcome
• Ongoing constipation
• Use of anticoagulant or antiplatelet medications excluding low-dose Acetylsalicylic acid (ASA)
• Hemophilia
• Any cardiac condition that requires the use of pre-procedure antibiotic prophylaxis such as a mechanical valve
• Currently receiving successful medical treatment for incontinence.
• The usage of male urethral slings
• Planning to travel by airplane during the course of the study