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

Urethral Stricture Clinical Trial

— ROBUST-II  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03270384
• Other study ID #: PR1032
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 25, 2017
• Est. completion date: June 2024

Study information

• Verified date: November 2022
• Source: Urotronic Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 16
• Est. completion date: June 2024
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Urethral Stricture

Intervention

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.

Locations

Country	Name	City	State
United States	Chesapeake Urology	Hanover	Maryland
United States	University of Iowa	Iowa City	Iowa
United States	University of Minnesota	Minneapolis	Minnesota
United States	Urology of Virginia	Virginia Beach	Virginia
United States	Metro Urology	Woodbury	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Urotronic Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety- Rate of Device Related Serious Complications		90 days
Secondary	Safety- Change in IIEF (International Index of Erectile Function)		90 days
Secondary	Efficacy- Stricture Recurrence Rate		6 months