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

• Sponsor: Urotronic Inc. (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03270384
• Collaborator: (none)
• Enrollment: 16
• Locations: 5
• Arm: 1
• Anticipated Duration (Months): 77.2
• Patients Per Site: 3.2
• Patients Per Site Per Month: 0

Study Details

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.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Device Feasibility
• Official Title: Re-establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease
• Actual Study Start Date: Oct 25, 2017
• Actual Primary Completion Date: Nov 1, 2019
• Anticipated Study Completion Date: Apr 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Up to 15 subjects will be enrolled and treated with the Urotronic drug coated balloon (DCB)	Device: Urotronic Drug Coated Balloon (DCB); 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.

Outcome Measures

Primary Outcome Measures

1. Safety- Rate of Device Related Serious Complications [90 days]

Secondary Outcome Measures

1. Safety- Change in IIEF (International Index of Erectile Function) [90 days]

2. Efficacy- Stricture Recurrence Rate [6 months]

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 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Iowa	Iowa City	Iowa	United States	52242
2	Chesapeake Urology	Hanover	Maryland	United States	21076
3	University of Minnesota	Minneapolis	Minnesota	United States	55455
4	Metro Urology	Woodbury	Minnesota	United States	55125
5	Urology of Virginia	Virginia Beach	Virginia	United States	23462

Sponsors and Collaborators

• Urotronic Inc.

Investigators

• Principal Investigator: Sean Elliott, MD, University of Minnesota

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Urotronic Inc.
• ClinicalTrials.gov Identifier: NCT03270384
• Other Study ID Numbers: PR1032
• First Posted: Sep 1, 2017
• Last Update Posted: Jun 8, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Urotronic Inc.: early feasibility; non-randomized
• Additional relevant MeSH terms: Urethral Stricture; Constriction, Pathologic

Study Results

No Results Posted as of Jun 8, 2021