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

NCT ID: NCT03270384

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-25
• Study Completion Date: 2025-02-19

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.

Conditions

Urethral Stricture

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Treatment

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

Group Type: EXPERIMENTAL

Urotronic Drug Coated Balloon (DCB)

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Urotronic Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sean Elliott, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Iowa

Iowa City, Iowa, United States

Chesapeake Urology

Hanover, Maryland, United States

University of Minnesota

Minneapolis, Minnesota, United States

Metro Urology

Woodbury, Minnesota, United States

Urology of Virginia

Virginia Beach, Virginia, United States

Countries

United States

Other Identifiers

PR1032

Identifier Type: -

Identifier Source: org_study_id