Status:
COMPLETED
Re-establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease
Lead Sponsor:
Urotronic Inc.
Conditions:
Urethral Stricture
Eligibility:
MALE
18+ years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 25 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 19 2025
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03270384
Start Date
October 25 2017
End Date
February 19 2025
Last Update
November 26 2025
Active Locations (5)
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1
University of Iowa
Iowa City, Iowa, United States, 52242
2
Chesapeake Urology
Hanover, Maryland, United States, 21076
3
University of Minnesota
Minneapolis, Minnesota, United States, 55455
4
Metro Urology
Woodbury, Minnesota, United States, 55125