ROBUST I Pilot Study

Study Overview
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Brief Summary
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Robust I study is a feasibility study for evaluating the safety and efficacy of DCB.

Detailed Description
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The study is designed to determine the safety and effectiveness for drug coated balloon (DCB). Up to 50 subjects is planned to be enrolled and treated with the study device at up to 5 clinical sites outside of US. Due to significantly higher prevalence of strictures in men vs. women and the etiology of those strictures being different, the study will focus on male subjects with single anterior urethral stricture. Subjects will be followed up post-treatment to one year and then annually for up to 5 years. The annual follow up after the first year is optional.

Official Title
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ROBUST I Pilot Study, ROBUST I Study, Re-Establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease

Conditions
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Stricture Urethra

Intervention / Treatment
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* Device: Urotronic Drug Coated Balloon (DCB)


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 urethrogram Single lesion anterior urethral stricture or bladder neck contracture, less than or equal to 2.0 cm One to three (1-3) prior diagnosis and treatment of the same stricture (including self-catheterization) including DVIU (Direct Vision 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. IPSS score of 13 or higher Lumen diameter <12F by urethrogram Able to complete validated questionnaire independently Qmax <10 ml/sec Exclusion Criteria: Strictures greater than 2.0 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 and are unable to complete study required testing, such as uroflowmetry Previous urethroplasty within the anterior urethra Stricture due to bacterial urethritis or untreated gonorrhea Stricture dilated or incised within the last 3 months Presence of local adverse factors, including abnormal prostate making catheterization difficult, urethral false passage or fistula. Presence of signs of obstructive voiding symptoms not directly attributable to the stricture such as BPH at the discretion of the clinical investigator Previous radical prostatectomy Previous pelvic radiation Diagnosed kidney, bladder, urethral or ureteral stones or active stone passage in the past 6 months. Diagnosed with chronic renal failure unless under hemodialysis or has a serum creatinine level greater than 2 mg/dL 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.) Use of Botox (onabotulinumtoxinA) in urinary system within the last 12 months

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 |
| --- | --- |
| Experimental: DCB Treatment<br>Stricture patients treated by DCB | Device: Urotronic Drug Coated Balloon (DCB)<br>* Urotronic Drug Coated Balloon (DCB) is a catheter with a tapered atraumatic tip. The distal end of the catheter has a semi-compliant inflatable balloon coated with a proprietary coating containing the drug and carriers.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Treatment Related Serious Complication | Device related formation of fistula; Device related de novo severe urinary retention | 90 days post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stricture Recurrence Rate | Improvement in IPSS (International Prostate Symptoms Score) | 90 days post-procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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reduced urine flow rate, low peak flow rate, urinary tract infections