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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03270384
Recruitment Status : Active, not recruiting
First Posted : September 1, 2017
Last Update Posted : November 23, 2022
Sponsor:
Information provided by (Responsible Party):
Urotronic Inc.

Study Description
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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) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : October 25, 2017
Actual Primary Completion Date : November 1, 2019
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Safety- Rate of Device Related Serious Complications [ Time Frame: 90 days ]

Secondary Outcome Measures :
  1. Safety- Change in IIEF (International Index of Erectile Function) [ Time Frame: 90 days ]
  2. Efficacy- Stricture Recurrence Rate [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03270384


Locations
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United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Maryland
Chesapeake Urology
Hanover, Maryland, United States, 21076
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Metro Urology
Woodbury, Minnesota, United States, 55125
United States, Virginia
Urology of Virginia
Virginia Beach, Virginia, United States, 23462
Sponsors and Collaborators
Urotronic Inc.
Investigators
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Principal Investigator: Sean Elliott, MD University of Minnesota
More Information
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Responsible Party: Urotronic Inc.
ClinicalTrials.gov Identifier: NCT03270384    
Other Study ID Numbers: PR1032
First Posted: September 1, 2017    Key Record Dates
Last Update Posted: November 23, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Urotronic Inc.:
early feasibility
non-randomized
Additional relevant MeSH terms:
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Urethral Stricture
Constriction, Pathologic
Pathological Conditions, Anatomical
 Urethral Obstruction
Urethral Diseases
Urologic Diseases