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

Exclusion Criteria

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