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

NCT03014726 | Completed Early Phase 1 Results FDA Device

• 1 other identifier: DSC016
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stricture Urethra

Keywords

reduced urine flow rate; low peak flow rate; urinary tract infections

Outcome Measures

Primary Outcomes (1)

• Rate of Treatment Related Serious Complication

  * 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.

  90 days post-procedure

Secondary Outcomes (1)

• Stricture Recurrence Rate

  90 days post-procedure

Study Arms (1)

DCB Treatment

EXPERIMENTAL

Stricture patients treated by DCB

Combination Product: Urotronic Drug Coated Balloon (DCB)

Interventions

Urotronic Drug Coated Balloon (DCB) COMBINATION_PRODUCT

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.

DCB Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Urotronic Inc.: lead

Study Sites (1)

Libra Medical Inc

Brooklyn Park, Minnesota, 55428, United States

Location

Related Publications (1)

• DeLong J, Virasoro R, Pichardo M, Estrella R, Rodriguez Lay R, Espino G, Elliott S. Long-Term Outcomes of Recurrent Bulbar Urethral Stricture Treatment With the Optilume Drug-Coated Balloon: Five-Year Results From the ROBUST I Study. J Urol. 2025 Jan;213(1):90-98. doi: 10.1097/JU.0000000000004229. Epub 2024 Aug 30.

  PMID: 39213367 DERIVED

MeSH Terms

Conditions

Urethral Stricture; Urinary Tract Infections

Condition Hierarchy (Ancestors)

Urethral Obstruction; Urethral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Infections

Results Point of Contact

• Title: Ian Schorn, Vice President of Clinical Affairs
• Organization: Urotronic, Inc.

schorni@urotronic.com

320.282.6312

Study Officials

• Ian Schorn

  Urotronic (Study Sponsor)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2017
• First Posted: January 9, 2017
• Study Start: November 1, 2016
• Primary Completion: October 1, 2018
• Study Completion: April 1, 2023
• Last Updated: March 22, 2024
• Results First Posted: March 22, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)