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ROBUST I Pilot Study (ROBUST)

Primary Purpose

Stricture Urethra

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Urotronic Drug Coated Balloon (DCB)

About this trial

This is an interventional treatment trial for Stricture Urethra focused on measuring reduced urine flow rate, low peak flow rate, urinary tract infections

Eligibility Criteria

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

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

Sites / Locations

Libra Medical Inc

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DCB Treatment

Arm Description

Stricture patients treated by DCB

Outcomes

Primary Outcome Measures

Rate of Treatment Related Serious Complication

Device related formation of fistula; Device related de novo severe urinary retention

Secondary Outcome Measures

Stricture Recurrence Rate

Improvement in IPSS (International Prostate Symptoms Score)

Full Information

NCT ID

NCT03014726

First Posted

January 5, 2017

Last Updated

April 26, 2021

Sponsor

Urotronic Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03014726

Brief Title

ROBUST I Pilot Study

Acronym

ROBUST

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Unknown status

Study Start Date

November 2016 (undefined)

Primary Completion Date

October 2018 (Actual)

Study Completion Date

April 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Urotronic Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stricture Urethra

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

DCB Treatment

Arm Type

Experimental

Arm Description

Stricture patients treated by DCB

Intervention Type

Device

Intervention Name(s)

Urotronic Drug Coated Balloon (DCB)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Rate of Treatment Related Serious Complication

Description

Device related formation of fistula; Device related de novo severe urinary retention

Time Frame

90 days post-procedure

Secondary Outcome Measure Information:

Title

Stricture Recurrence Rate

Description

Improvement in IPSS (International Prostate Symptoms Score)

Time Frame

90 days post-procedure

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ian Schorn

Organizational Affiliation

Urotronic (Study Sponsor)

Official's Role

Study Director

Facility Information:

Facility Name

Libra Medical Inc

City

Brooklyn Park

State/Province

Minnesota

ZIP/Postal Code

55428

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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ROBUST I Pilot Study

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