Re-Establishing Flow Via Drug Coated Balloon for the Treatment of Urethral Stricture Disease - Registry Study

Exclusion Criteria

• •1. Strictures greater than 3.0 cm long
• •2. Subjects with greater than 1 stricture.
• •3. Sensitivity to paclitaxel or on medication that may have negative interaction with paclitaxel
• •4. Previous urethroplasty within the anterior urethra
• •5. Stricture due to bacterial urethritis
• •6. Stricture due to untreated gonorrhea
• •7. Stricture due to Lichen Sclerosus, or balanitis xerotica obliterans (BXO)
• •8. Stricture dilated or incised within the last 3 months (apart from subjects on self-catheterization)
• •9. Presence of local adverse factors (e.g. abnormal prostate, urethral false passage or fistula) making catheterization difficult
• •10. Presence of signs of obstructive voiding symptoms not directly attributable to the stricture at the discretion of the physician
• •11. Diagnosis of untreated and unresolved severe BPH or bladder neck contracture (BNC), at the discretion of the physician
• •12. Prior diagnosis of overactive bladder (OAB)
• •13. Diagnosis of severe stress urinary incontinence (SUI), at the discretion of the physician
• •14. Previous radical prostatectomy that resulted in either unresolved bladder neck contracture (BNC) and/or unresolved incontinence
• •15. Previous pelvic radiation
• •16. Diagnosis of kidney, bladder, urethral or ureteral stones in the last 6 weeks or active stone passage in the past 6 weeks
• •17. Diagnosed with chronic renal failure, at the discretion of the physician
• •18. A dependence on Botox (onabotulinumtoxinA) in the urinary system
• •19. Presence of a penile implant, artificial urinary sphincter, or stent(s) in the urethra or prostate
• •20. Known neurogenic bladder, sphincter abnormalities, or poor detrusor muscle function
• •21. Previous hypospadias repair
• •22. Diagnosis within the last 5 years of carcinoma of the bladder or prostate or suspicion of prostate cancer (e.g. abnormal DRE or high PSA) at the discretion of the physician
• •23. Any cognitive or psychiatric condition that interferes with or precludes direct and accurate communication with the study investigator regarding the study or affect the ability to complete the study quality of life questionnaires
• •24. Unwilling to use protected sex for ≥30 days post treatment
• •25. Unwilling to abstain or use protected sex for 90 days post treatment if sexual partner is of child bearing potential.
• •26. Inability to provide legally effective Informed Consent Form (ICF) and/or comply with all the required follow-up requirements
• •27. Active infection in the urinary system
• •28. History of diabetes not controlled with a hemoglobin A1-C \>7.0%
• •29. Diagnosed or suspected primary neurologic conditions such as multiple sclerosis or Parkinson's disease or other neurological diseases known to affect bladder function, sphincter function or poor detrusor muscle function.
• •30. Visible hematuria with subject urine sample without known contributing factor