Re-Establishing Flow Via Drug Coated Balloon for the Treatment of Urethral Stricture Disease - Registry Study
Re-Establishing Flow Via Drug Coated Balloon for the Treatment of Urethral Stricture Disease - Registry Study
The ROBUST IV study is designed to collect and better understand "real-world" outcomes for
 men undergoing urethral dilation using the Optilume Drug Coated Balloon (DCB) for treatment
 of urethral stricture.
Inclusion Criteria:

 1. Male subjects ≥ 18 years old

 2. Visual confirmation of stricture via cystoscopy or retrograde urethrogram

 3. Single lesion bulbar urethral stricture, less than or equal to 3.0 cm

 4. Significant symptoms of stricture such as frequency of urination, dysuria, urgency,
 hematuria, slow flow, feeling of incomplete emptying, recurrent urinary tract
 infections (UTIs).

 5. IPSS score of 13 or higher

 6. Lumen diameter <12F by urethrogram

 7. Able to complete validated questionnaire independently

 8. Qmax <15 ml/sec

 9. Guidewire must be able to cross the lesion

 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