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

Early Phase 1

Completed

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

Detailed Description: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
DCB Treatment	Urotronic Drug Coated Balloon (DCB)	Stricture patients treated by DCB

Primary Outcome Measures

Name	Time	Method
Rate of Treatment Related Serious Complication	90 days post-procedure	* urethral formation of fistula * de novo severe urinary retention lasting \> 14 consecutive days' post-treatment * unresolved de novo stress urinary incontinence (requiring \>1 pad/day) at 90 days or earlier * urethra rupture or burst.

Secondary Outcome Measures

Name	Time	Method
Stricture Recurrence Rate	90 days post-procedure	* IPSS score of greater than 11 at the 90-day follow-up, or * if a subject had a second DCB treatment (retreatment), or * if a subject exited the study early due to treatment failure (IPSS \>11 without cystoscopically confirmed anatomical success at the time of exit or receiving additional stricture treatment with an alternative therapy).