Re-establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease

Exclusion Criteria

• •1. Strictures greater than 3.0 cm long.
• •2. Subjects that have more than 1 stricture.
• •3. Sensitivity to paclitaxel or on medication that may have negative interaction with paclitaxel
• •4. Subjects who have a suprapubic catheter
• •5. Previous urethroplasty within the anterior urethra
• •6. Stricture due to bacterial urethritis or untreated gonorrhea
• •7. Stricture dilated or incised within the last 3 months
• •8. History of over active bladder or stress incontinence
• •9. Previous radical prostatectomy
• •10. Previous pelvic radiation
• •11. Diagnosed kidney, bladder, urethral or ureteral stones or active stone passage in the past 6 months.
• •12. Presence of a penile implant, artificial urinary sphincter, or stent(s) in the urethra or prostate
• •13. Known neurogenic bladder, sphincter abnormalities, or poor detrusor muscle function