NCT03270384

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

October 25, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
5.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 19, 2025

Completed
Last Updated

November 26, 2025

Status Verified

July 1, 2025

Enrollment Period

2 years

First QC Date

August 30, 2017

Last Update Submit

November 25, 2025

Conditions

Urethral Stricture

Keywords

early feasibilitynon-randomized

Outcome Measures

Primary Outcomes (1)

  • Safety- Rate of Device Related Serious Complications

    90 days

Secondary Outcomes (2)

  • Safety- Change in IIEF (International Index of Erectile Function)

    90 days

  • Efficacy- Stricture Recurrence Rate

    6 months

Study Arms (1)

Treatment

EXPERIMENTAL

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

Device: Urotronic Drug Coated Balloon (DCB)

Interventions

Urotronic Drug Coated Balloon (DCB)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.

Treatment

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male subjects ≥ 18 years' old
  • Visual confirmation of stricture via cystoscopy or urethrogram
  • Single lesion anterior urethral stricture less than or equal to 3 cm
  • Two (2) or more prior diagnosis and treatment of stricture treatments (including self-catheterization) including DVIU (direct visual 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 (urinary tract infections).
  • IPSS (International Prostate Symptom Score) score of 13 or higher
  • Lumen diameter \<12F by urethrogram
  • Able to complete validated questionnaire independently
  • Qmax \<12 ml/sec
  • Guidewire must be able to cross the lesion

You may not qualify if:

  • Strictures greater than 3.0 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
  • Previous urethroplasty within the anterior urethra
  • Stricture due to bacterial urethritis or untreated gonorrhea
  • Stricture dilated or incised within the last 3 months
  • History of over active bladder or stress incontinence
  • Previous radical prostatectomy
  • Previous pelvic radiation
  • Diagnosed kidney, bladder, urethral or ureteral stones or active stone passage in the past 6 months.
  • Presence of a penile implant, artificial urinary sphincter, or stent(s) in the urethra or prostate
  • Known neurogenic bladder, sphincter abnormalities, or poor detrusor muscle function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Chesapeake Urology

Hanover, Maryland, 21076, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Metro Urology

Woodbury, Minnesota, 55125, United States

Location

Urology of Virginia

Virginia Beach, Virginia, 23462, United States

Location

MeSH Terms

Conditions

Urethral Stricture

Condition Hierarchy (Ancestors)

Urethral ObstructionUrethral DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Sean Elliott, MD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2017

First Posted

September 1, 2017

Study Start

October 25, 2017

Primary Completion

November 1, 2019

Study Completion

February 19, 2025

Last Updated

November 26, 2025

Record last verified: 2025-07

Locations

US(5)