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

Study Overview
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Brief Summary
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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.

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

Conditions
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Urethral Stricture, Urethral Stricture, Anterior, Lower Urinary Tract Symptoms, Anterior Urethral Stricture

Intervention / Treatment
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* Device: Optilume Drug Coated Balloon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male subjects ≥ 18 years old Visual confirmation of stricture via cystoscopy or retrograde urethrogram Single lesion bulbar urethral stricture, less than or equal to 3.0 cm Significant symptoms of stricture such as frequency of urination, dysuria, urgency, hematuria, slow flow, feeling of incomplete emptying, recurrent urinary tract infections (UTIs). IPSS score of 13 or higher Lumen diameter <12F by urethrogram Able to complete validated questionnaire independently Qmax <15 ml/sec Guidewire must be able to cross the lesion Exclusion Criteria: Strictures greater than 3.0 cm long Subjects with greater than 1 stricture. Sensitivity to paclitaxel or on medication that may have negative interaction with paclitaxel Previous urethroplasty within the anterior urethra Stricture due to bacterial urethritis Stricture due to untreated gonorrhea Stricture due to Lichen Sclerosus, or balanitis xerotica obliterans (BXO) Stricture dilated or incised within the last 3 months (apart from subjects on self-catheterization) Presence of local adverse factors (e.g. abnormal prostate, urethral false passage or fistula) making catheterization difficult Presence of signs of obstructive voiding symptoms not directly attributable to the stricture at the discretion of the physician Diagnosis of untreated and unresolved severe BPH or bladder neck contracture (BNC), at the discretion of the physician Prior diagnosis of overactive bladder (OAB) Diagnosis of severe stress urinary incontinence (SUI), at the discretion of the physician Previous radical prostatectomy that resulted in either unresolved bladder neck contracture (BNC) and/or unresolved incontinence Previous pelvic radiation Diagnosis of kidney, bladder, urethral or ureteral stones in the last 6 weeks or active stone passage in the past 6 weeks Diagnosed with chronic renal failure, at the discretion of the physician A dependence on Botox (onabotulinumtoxinA) in the urinary system 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 Previous hypospadias repair 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 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 Unwilling to use protected sex for ≥30 days post treatment Unwilling to abstain or use protected sex for 90 days post treatment if sexual partner is of child bearing potential. Inability to provide legally effective Informed Consent Form (ICF) and/or comply with all the required follow-up requirements Active infection in the urinary system History of diabetes not controlled with a hemoglobin A1-C >7.0% 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. Visible hematuria with subject urine sample without known contributing factor

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Optilume DCB<br>Optilume Drug Coated Balloon (DCB) treatment for the treatment of urethral stricture as approved for use in Canada | Device: Optilume Drug Coated Balloon<br>* The Optilume Drug Coated Balloon (DCB) is a guidewire compatible catheter with a tapered atraumatic tip. The distal end of the catheter has an inflatable balloon coated with a proprietary coating containing the drug paclitaxel that facilitates the drug's transfer to the urethral wall upon inflation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stricture Recurrence Rate | Stricture Free Rate | 12 months | 
| Rate of Serious Adverse Events | Major Device or Procedure Related Serious Adverse Events | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Uroflow | Change in Qmax (peak flow rate) | 3 and 12 months | 
| Change in the International Prostate Symptom Score Questionnaire (IPSS) | IPSS Percent Responder (50% improvement in IPSS score or IPSS score of 11 or lower) | 3 and 12 months | 
| Change in the EQ-5D Quality of Life Questionnaire | Change in the EQ-5D at 3 and 12 months post-procedure compared to baseline. Subscales of mobility, self-care, usual activities, pain/discomfort and anxiety/depression on a scale of 1 (no problem) to 5 (extreme problems) | 3 and 12 months | 
| Change in the International Index of Erectile Function Questionnaire (IIEF) | Change in the IIEF at 3 and 12 months post-procedure compared to baseline on a scale of 5 (severe erectile dysfunction) to 25 (no erectile dysfunction) | 3 and 12 months | 
| Change in the Male Sexual Health Questionnaire (MSHQ-EjD) | Change in the MSHQ-EjD at 3 and 12 months post-procedure compared to baseline. Subscales of ejaculatory function from 1 (more ejaculatory dysfunction) to 15 (less ejaculation dysfunction) and bother from 0 (no bother with ejaculation) to 5 (greater bother with ejaculation) | 3 and 12 months |