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



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:4/3/2019
Start Date:October 25, 2017
End Date:December 2022
Contact:Laura Moffett
Email:moffettl@urotronic.com
Phone:763-285-7489

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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.


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
We found this trial at
5
sites
Minneapolis, Minnesota 55455
(612) 625-5000
Principal Investigator: Sean Elliott, MD
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
Principal Investigator: Bradley Erickson, MD
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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Iowa City, IA
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7580 Buckingham Boulevard
Hanover, Maryland 21076
Principal Investigator: Kaiser Robertson, MD
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Hanover, MD
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Virginia Beach, Virginia 23462
Principal Investigator: Ramon Virasoro, MD
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Virginia Beach, VA
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Woodbury, Minnesota 55125
Principal Investigator: Michael Ehlert, MD
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Woodbury, MN
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