ROBUST I Pilot Study

• Sponsor: Urotronic Inc. (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03014726
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arm: 1
• Duration (Months): 76.9
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Stricture Urethra	Device: Urotronic Drug Coated Balloon (DCB)	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: ROBUST I Pilot Study, ROBUST I Study, Re-Establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease
• Study Start Date: Nov 1, 2016
• Actual Primary Completion Date: Oct 1, 2018
• Anticipated Study Completion Date: Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DCB Treatment Stricture patients treated by DCB	Device: Urotronic Drug Coated Balloon (DCB); 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.

Outcome Measures

Primary Outcome Measures

1. Rate of Treatment Related Serious Complication [90 days post-procedure]

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

Secondary Outcome Measures

1. Stricture Recurrence Rate [90 days post-procedure]

   Improvement in IPSS (International Prostate Symptoms Score)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Male subjects ≥ 18 years' old

2. Visual confirmation of stricture via cystoscopy or urethrogram

3. Single lesion anterior urethral stricture or bladder neck contracture, less than or equal to 2.0 cm

4. 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

5. Significant symptoms of stricture such as frequency of urination, dysuria, urgency, hematuria, slow flow, feeling of incomplete emptying, recurrent UTI's.

6. IPSS score of 13 or higher

7. Lumen diameter <12F by urethrogram

8. Able to complete validated questionnaire independently

9. Qmax <10 ml/sec

Exclusion Criteria:

1. Strictures greater than 2.0 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 and are unable to complete study required testing, such as uroflowmetry

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. Presence of local adverse factors, including abnormal prostate making catheterization difficult, urethral false passage or fistula.

9. Presence of signs of obstructive voiding symptoms not directly attributable to the stricture such as BPH at the discretion of the clinical investigator

10. Previous radical prostatectomy

11. Previous pelvic radiation

12. Diagnosed kidney, bladder, urethral or ureteral stones or active stone passage in the past 6 months.

13. Diagnosed with chronic renal failure unless under hemodialysis or has a serum creatinine level greater than 2 mg/dL

14. 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.)

15. Use of Botox (onabotulinumtoxinA) in urinary system within the last 12 months

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Libra Medical Inc	Brooklyn Park	Minnesota	United States	55428

Sponsors and Collaborators

• Urotronic Inc.

Investigators

• Study Director: Ian Schorn, Urotronic (Study Sponsor)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Urotronic Inc.
• ClinicalTrials.gov Identifier: NCT03014726
• Other Study ID Numbers: DSC016
• First Posted: Jan 9, 2017
• Last Update Posted: Apr 27, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Urotronic Inc.: reduced urine flow rate; low peak flow rate; urinary tract infections
• Additional relevant MeSH terms: Constriction, Pathologic

Study Results

No Results Posted as of Apr 27, 2021