ROBUST III- Re-Establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease

ROBUST III is a prospective, multi-center, randomized controlled adaptive sample size clinical trial to establish the safety and effectiveness for the Optilume Stricture Drug Coated Balloon (DCB).

ROBUST III is a prospective, multi-center, single blind randomized controlled clinical trial in a 2:1 allocation of treatment versus control device.

This study is an adaptive design with an interim analysis for sample size re-estimation performed after 60 subjects have been enrolled. The interim analysis will be be undertaken following completion of the 6-month follow-up data from these subjects. Based on the results of the interim analysis, the final total sample size required for the study will be re-estimated. A minimum of 140 subjects, and a maximum of 200 subjects (pending the re-estimation) will be enrolled in the study. A Data Monitoring Committee (DMC) will review the interim analysis results, including the sample size re-estimation and make recommendations related to trial continuation to the sponsor.

Eligibility Criteria:
Inclusion Criteria:

1. Male subjects ≥ 18 years' old
2. Visual confirmation of stricture via cystoscopy or urethrogram
3. Single, tandem or diffuse anterior urethral stricture(s), less than or equal to 3.0 cm total length measured by retrograde urethrogram. (Stricture length is defined as the distance between the most distal edge of the stricture to the most proximal edge of the stricture).
4. Two or more prior dilation treatments of the same stricture, including DVIU (Direct Vision Internal Urethrotomy), but no prior urethroplasty.
5. Significant symptoms of stricture such as frequency of urination, dysuria, urgency, hematuria, slow flow, feeling of incomplete emptying, recurrent urinary tract infections (UTI's).
6. International Prostrate Symptoms Score (IPSS) score of 11 or higher (assumed to be "35" if suprapubic catheter is present)
7. Lumen diameter ≤ 12F by urethrogram
8. Qmax \<15 ml/sec (assumed to be "0" if suprapubic catheter is present)
9. Guidewire must be able to cross the lesion

Exclusion Criteria:

1. Subjects with diffuse stricture length, greater than 3.0 cm in total length. (Stricture length is defined as the distance between the most distal edge of the stricture to the most proximal edge of the stricture).
2. Subjects with a history of hypersensitivity reactions to TAXOL, on medication that may have negative interaction with paclitaxel, with solid tumors who have a baseline neutrophil counts of \<1500 cells/mm3 or subjects with AIDS-related Kaposi's sarcoma with baseline neutrophile counts of \<1000 cells/mm3.
3. Subjects who had an indwelling suprapubic catheter longer than three (3) months total prior to enrollment.
4. Previous urethroplasty within the anterior urethra
5. Stricture dilated or incised within the last six (6) weeks (urethral catheterization is not considered dilation)
6. Presence of local adverse factors, including abnormal prostate making catheterization difficult, urethral false passage or fistula.
7. Presence of signs of obstructive voiding symptoms not directly attributable to the stricture at the discretion of the physician
8. Diagnosis of untreated and unresolved BPH or BNC
9. Untreated stress urinary incontinence (SUI).
10. History of diagnosed radiation cystitis.
11. Diagnosis of carcinoma of the urethra, bladder or prostate within the last two (2) years
12. Active kidney, bladder, urethral or ureteral stone passage in the last six (6) weeks or concern of stone passage in the next 6 weeks at the discretion of the investigator.
13. Diagnosis of chronic renal failure and treatment with hemodialysis
14. New diagnosis of OAB (overactive bladder) within the last six (6) months
15. Use of alpha blockers, beta blockers, OAB (Overactive Bladder) medication, anticonvulsants (drugs that prevent or reduce the severity and frequency of seizures), and antispasmodics where the dose is not stable. (Stable dose is defined as having the same medication and dose in the last six months.)
16. Dependence on Botox (onabotulinumtoxinA) in urinary system
17. Presence of an artificial urinary sphincter, slings, or stent(s) in the urethra or prostate
18. Known neurogenic bladder, sphincter abnormalities, or poor detrusor muscle function
19. Diagnosed with Lichen Sclerosus, or stricture due to balanitis xerotica obliterans (BXO)
20. Previous hypospadias repair
21. History of cancer in non-genitourinary system which is not considered in complete remission (except basal cell or squamous cell carcinoma of the skin). A potential participant is considered in complete remission if there has been no evidence of cancer within two (2) years of enrollment
22. 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
23. Unwilling to use protected sex for thirty (30) days' post treatment
24. Unwilling to abstain or use protected sex for ninety (90) days post treatment if sexual partner is of child bearing potential.
25. Inability to provide Informed Consent Form (ICF) and/or comply with all the required follow-up requirements
26. Participation in other pre-market studies or treatment with an investigational drug or device. Long term follow up or post market study of an approved device is allowed.
27. Current active infection in the urinary system
28. Current uncontrolled diabetes (hemoglobin A1c \> 8.0%) or evidence of poor wound healing due to diabetes
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 in subject's urine sample without known contributing factor
31. Invisible hematuria (or significant microscopic hematuria, i.e. hematuria of ≥ 3 RBC's/HPF) that may be caused by a clinically significant disease unless it is attributed to the urethral stricture disease or other causes which are benign and not requiring treatment.