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

Validation Study: A Prospective, Non-Randomized, Single Arm Trial to Assess the Efficacy of the Comfort Plug™ in Preventing Urinary Incontinence in Male Subjects With Post Prostatectomy Urinary Incontinence (COMFORT STUDY)

Validation Study: A Prospective, Non-Randomized, Single Arm Trial to Assess the Efficacy of the Comfort Plug™ in Preventing Urinary Incontinence in Male Subjects with Post Prostatectomy 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:

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

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