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

Study Overview
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Brief Summary
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The study described below is designed to assess the safety and device performance for the drug coated balloon (DCB) for the treatment of urethral stricture.

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

Conditions
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Urethral Stricture

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 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

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: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Up to 15 subjects will be enrolled and treated with the Urotronic drug coated balloon (DCB) | Device: Urotronic Drug Coated Balloon (DCB)<br>* The Urotronic 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 |
| --- | --- | --- |
| Safety- Rate of Device Related Serious Complications |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety- Change in IIEF (International Index of Erectile Function) |  | 90 days | 
| Efficacy- Stricture Recurrence Rate |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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early feasibility, non-randomized