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 @ 9:14 PM
Ignite Modification Date:
2025-12-24 @ 9:14 PM
NCT ID:
NCT00270504
Eligibility Criteria:
Inclusion Criteria:
1. Males \> 21 years of age
2. Recurrent stricture of the bulbar urethra:
1. \< 50 mm in length on urethrography; and which
2. has a segment unable to accommodate a 16Fr flexible cystoscope
3. Healthy tissue on both sides of stent
4. Urinary flow in the abnormal range of the Siroky nomogram.
5. Written informed consent obtained prior to participation in the study
6. Patients must be available for all follow-up visits.
Exclusion Criteria:
1. Strictures:
1. outside the bulbous urethra
2. associated with, or suspected to be, urethral carcinoma
3. secondary to pelvic distraction injuries
2. Inability to enlarge the bulbar urethral stricture to \> 26 Fr.
3. Presence of any other urologic implant
4. Presence of urethral diverticuli
5. History of hypospadias repair
6. Presence or prior history of balanitis xerotica obliterans.
7. Uncontrolled bleeding disorder
8. Active urinary tract infection
9. Any urological condition that would be likely to require additional urethral instrumentation during the period of the investigation, including, but not limited to, benign prostatic hypertrophy requiring treatment; use of alpha blockers; active prostate cancer; an unevaluated elevated prostate-specific antigen (PSA); bladder malignancy; or any recurrent urinary stone formation.
10. Serum creatinine \> 2.0 mg/dl or evidence of progressive renal disease
11. Concurrent participation in another clinical investigation
12. Current illness that might confound the results of this investigation
13. Inability to participate in all of the necessary study activities
14. Inability or unwillingness to return for all required follow-up visits
15. Inability or unwillingness to sign the patient informed consent document
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
21 Years
Study:
NCT00270504
Study Brief:
Protocol Section:
NCT00270504