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Re-establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease (ROBUST-II)

Primary Purpose

Urethral Stricture

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Urotronic Drug Coated Balloon (DCB)
Sponsored by
Urotronic Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Urethral Stricture focused on measuring early feasibility, non-randomized

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male subjects ≥ 18 years' old
  2. Visual confirmation of stricture via cystoscopy or urethrogram
  3. Single lesion anterior urethral stricture less than or equal to 3 cm
  4. Two (2) or more prior diagnosis and treatment of stricture treatments (including self-catheterization) including DVIU (direct visual internal urethrotomy), but no prior urethroplasty
  5. Significant symptoms of stricture such as frequency of urination, dysuria, urgency, hematuria, slow flow, feeling of incomplete emptying, recurrent UTI's (urinary tract infections).
  6. IPSS (International Prostate Symptom Score) score of 13 or higher
  7. Lumen diameter <12F by urethrogram
  8. Able to complete validated questionnaire independently
  9. Qmax <12 ml/sec
  10. Guidewire must be able to cross the lesion

Exclusion Criteria:

  1. Strictures greater than 3.0 cm long.
  2. Subjects that have more than 1 stricture.
  3. Sensitivity to paclitaxel or on medication that may have negative interaction with paclitaxel
  4. Subjects who have a suprapubic catheter
  5. Previous urethroplasty within the anterior urethra
  6. Stricture due to bacterial urethritis or untreated gonorrhea
  7. Stricture dilated or incised within the last 3 months
  8. History of over active bladder or stress incontinence
  9. Previous radical prostatectomy
  10. Previous pelvic radiation
  11. Diagnosed kidney, bladder, urethral or ureteral stones or active stone passage in the past 6 months.
  12. Presence of a penile implant, artificial urinary sphincter, or stent(s) in the urethra or prostate
  13. Known neurogenic bladder, sphincter abnormalities, or poor detrusor muscle function

Sites / Locations

  • University of Iowa
  • Chesapeake Urology
  • University of Minnesota
  • Metro Urology
  • Urology of Virginia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Up to 15 subjects will be enrolled and treated with the Urotronic drug coated balloon (DCB)

Outcomes

Primary Outcome Measures

Safety- Rate of Device Related Serious Complications

Secondary Outcome Measures

Safety- Change in IIEF (International Index of Erectile Function)
Efficacy- Stricture Recurrence Rate

Full Information

First Posted
August 30, 2017
Last Updated
November 21, 2022
Sponsor
Urotronic Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03270384
Brief Title
Re-establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease
Acronym
ROBUST-II
Official Title
Re-establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 25, 2017 (Actual)
Primary Completion Date
November 1, 2019 (Actual)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Urotronic Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urethral Stricture
Keywords
early feasibility, non-randomized

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Up to 15 subjects will be enrolled and treated with the Urotronic drug coated balloon (DCB)
Intervention Type
Device
Intervention Name(s)
Urotronic Drug Coated Balloon (DCB)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Safety- Rate of Device Related Serious Complications
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Safety- Change in IIEF (International Index of Erectile Function)
Time Frame
90 days
Title
Efficacy- Stricture Recurrence Rate
Time Frame
6 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sean Elliott, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Chesapeake Urology
City
Hanover
State/Province
Maryland
ZIP/Postal Code
21076
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Metro Urology
City
Woodbury
State/Province
Minnesota
ZIP/Postal Code
55125
Country
United States
Facility Name
Urology of Virginia
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23462
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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