Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:58 PM
Ignite Modification Date:
2025-12-24 @ 2:58 PM
NCT ID:
NCT03605459
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT03605459
Study Brief:
Protocol Section:
NCT03605459