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

Inclusion criteria

• Male subjects ≥ 18 years' old
• Visual confirmation of stricture via cystoscopy or urethrogram
• Single lesion anterior urethral stricture less than or equal to 3 cm
• Two (2) or more prior diagnosis and treatment of stricture treatments (including self-catheterization) including DVIU (direct visual internal urethrotomy), but no prior urethroplasty
• Significant symptoms of stricture such as frequency of urination, dysuria, urgency, hematuria, slow flow, feeling of incomplete emptying, recurrent UTI's (urinary tract infections).
• IPSS (International Prostate Symptom Score) score of 13 or higher
• Lumen diameter <12F by urethrogram
• Able to complete validated questionnaire independently
• Qmax <12 ml/sec
• Guidewire must be able to cross the lesion

Exclusion criteria

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